CHICAGO, June 2, 2018 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) today announced presentation of preliminary data from the ongoing PIVOT Phase 1/2 Study, which is evaluating the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214. The preliminary results presented at the 2018 American Society of Clinical Oncology (ASCO) reported safety, efficacy and biomarker data for patients enrolled in the Phase 1 dose-escalation stage of the study and for the first patients consecutively enrolled in select dose expansion cohorts in Phase 2. Data were presented today in an oral presentation (Oral Abstract Session: Developmental Therapeutics—Immunotherapy, Abstract #3006, 5:00 p.m. – 5:15 p.m. CT, Hall B1).

Enrollment is ongoing in the Phase 2 stage of the PIVOT study in over 400 patients with melanoma, renal cell, urothelial, non-small cell lung and triple negative breast cancers.
Preliminary results from the ongoing PIVOT study presented today showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. As a result, Nektar and Bristol-Myers Squibb will initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer. 
“In the Phase 1 dose-escalation and Phase 2 expansion stages of the PIVOT trial to-date, we’ve observed important responses, including activity in PD-L1 negative patients,” said Mary Tagliaferri, M.D., Senior Vice President of Clinical Development and Chief Medical Officer at Nektar Therapeutics.  “We look forward to advancing this combination into Phase 3.”
The PIVOT study incorporates a Fleming 2-Stage Design, with efficacy targets separately pre-defined for each tumor type using a historical objective response rate (for single-agent checkpoint inhibitor).¹ If the efficacy criteria at the recommended Phase 2 dose (RP2D) is met in the first stage (N1) of patients consecutively enrolled or in the second stage (N1 + N2) of patients consecutively enrolled, the combination regimen would be advanced to registrational trials in that tumor type.
Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. NKTR-214 is an investigational immuno-stimulatory therapy designed to expand and activate specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of cell-surface PD-1 on these immune cells.
“Researching IL-2 pathway agonism and anti-PD-1 in combination may be a key strategy to more effectively activate an anti-tumor immune response,” said Fouad Namouni, M.D., Head of Oncology Development, Bristol-Myers Squibb. “These preliminary results from PIVOT are encouraging, particularly in the PD-L1 negative population, and support our belief that NKTR-214, a CD122 biased IL2 agonist, in combination with Opdivo can potentially expand the treatment benefits we can bring to patients with cancer.”
Highlights from the oral presentation include:
Clinical Efficacy (Response measured per RECIST 1.1 for efficacy-evaluable patients (treated at the recommended Phase 2 dose and with >1 on treatment scan.)  Response and median time on study calculated from data cut as of May 29, 2018):

• Stage IV Metastatic Treatment-Naïve 1L Melanoma Patients (Enrolled Per Fleming 2-Stage Design at RP2D):
• • Pre-specified efficacy criteria were met for Objective Response Rate (ORR) in Stage 1 (N1=13) with 11/13 (85%) of patients achieving either a partial response (PR) or complete response (CR). Median time on study for 28 patients in Stage 2 (N1+N2) is 4.6 months.  Responses were observed in 14/28 (50%) patients (3 CR, 10 PR, 1 uPR).  Amongst the 25 patients with known PD-L1 status, ORR in PD-L1 negative patients was 5/12 (42%) and in PD-L1 positive patients was 8/13 (62%).  One patient with unknown PD-L1 baseline status experienced a CR.
• Stage IV Metastatic Treatment-Naïve 1L Renal Cell Carcinoma Patients (Enrolled Per Fleming 2-Stage Design at RP2D):
• • Pre-specified efficacy criteria were met for ORR in Stage 1 (N1=11) with 7/11 (64%) of patients achieving a partial response (PR).  Median time on study for 26 patients in Stage 2 (N1 + N2) is 5.6 months.  Responses were observed in 12/26 (46%) patients (11 PR, 1 uPR).  Amongst the 24 patients with known PD-L1 status, the ORR in PD-L1 negative patients was 9/17 (53%) and in PD-L1 positive patients was 2/7 (29%). One of two patients (50%) with unknown PD-L1 baseline status experienced a PR.  
• Stage IV Metastatic Treatment-Naïve 1L Urothelial Carcinoma (Enrolled Per Fleming 2-Stage Design at RP2D):
• • Pre-specified efficacy criteria were met for ORR in Stage 1 (N1=10) with 6/10 (60%) of patients achieving either a partial or complete response (2 uCR, 3 PR, 1 uPR). Median time on study for 10 patients in Stage 1 is 3.9 months. The ORR in PD-L1 negative patients was 3/5 (60%) and in PD-L1 positive patients was 3/5 (60%). 

Biomarkers and Mechanism of Action:

• Data presented show conversion of PD-L1 negative status at baseline to PD-L1 positive status at week 3 in 9/17 patients (53%). Of these previously PD-L1 negative patients, 78% achieved clinical benefit as defined by stable disease, partial response or complete response.

Clinical Safety (Safety database as of May 7, 2018):

• A total of 283 patients have been treated at the RP2D. The most common treatment-related adverse events (TRAEs) were grade 1-2 flu-like symptoms (58.7%), rash (44.5%), fatigue (42.0%), and pruritus (31.4%). A total of 40/283 (14.1%) of patients experienced a Grade 3 (G3) or higher TRAE with 6/283 (2.1%) patients discontinuing treatment due to a TRAE. 10/283 (3.5%) of patients experienced a G3 or higher immune-mediated AE.  There was one nivolumab-related G5 pneumonitis reported.

A copy of the full data presentation made by Dr. Diab is available on Nektar’s corporate website at http://www.nektar.com/download_file/599/00.
Nektar and Bristol-Myers Squibb entered into a global strategic development and commercialization collaboration for NKTR-214 in February 2018. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb’s nivolumab and Opdivo plus Yervoy (ipilimumab) in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.
About NKTR-214
NKTR-214 preferentially binds to the CD122 receptor on the surface of cancer-fighting immune cells in order to stimulate their proliferation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment.^2,3,4 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
Nektar will webcast an analyst and investor event to review data presented in the oral session and new additional data from the PIVOT study on Saturday, June 2, 2018 at 6:45 p.m. CDT in Chicago, IL. PIVOT clinical investigators attending include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Scott N. Gettinger, Associate Professor, Medical Oncology at the Yale Cancer Center and Dr. Nizar M. Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center. Investors and analysts are invited to listen to a live audio webcast of the event, which will be accessible from the home page of the company’s website www.nektar.com. The webcast will also be available for replay for two weeks following the event.
About Nektar
Nektar Therapeutics is a research-based biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are advancing the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. Through our leading translational capabilities, we are pioneering immune biology research and identifying a number of potentially predictive biomarkers, including PD-L1, TMB, MSI-H/dMMR and LAG-3, advancing the possibility of precision medicine for more patients with cancer.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
U.S. FDA-APPROVED INDICATIONS FOR OPDIVO ^®
OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO^® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO^® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO^® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with intermediate or poor-risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO^® (nivolumab) is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO^® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients.
In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16.6% (91/547) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.
If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate study in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with ipilimumab 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients receiving sunitinib. The most frequent serious adverse reactions reported in at least 2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 040, serious adverse reactions occurred in 49% of patients (n=154). The most frequent serious adverse reactions reported in at least 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in at least 2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia (23% vs 16%), and decreased appetite (21% vs 29%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). The most common adverse reactions (≥20%) in patients who received OPDIVO as a single agent were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, and abdominal pain.
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).
Checkmate Trials and Patient Populations
Checkmate 067–advanced melanoma alone or in combination with YERVOY^® (ipilimumab); Checkmate 037 and 066–advanced melanoma; Checkmate 017–squamous non-small cell lung cancer (NSCLC); Checkmate 057–non-squamous NSCLC; Checkmate 025–renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 040–hepatocellular carcinoma, Checkmate 238–adjuvant treatment of melanoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that NKTR-214, alone or in combination with Opdivo will receive regulatory approval for any of the indications described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2017 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Nektar Therapeutics Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-214 in combination with Opdivo, observations from early data emerging from ongoing clinical trials of NKTR-214, and the potential of our technology and drug candidates in our research and development pipeline.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of NKTR-214 in combination with Opdivo are based on findings and observations from ongoing clinical studies and these findings and observations will evolve over time as more data emerges from the studies; (ii) NKTR-214 is in early stage clinical development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors; (iii) the initial preliminary RECIST response data reported in this press release is subject to change—in particular, there is no way to predict whether unconfirmed responses will become confirmed responses as the clinical studies progress; (iv) the preliminary clinical results from the NKTR-214 clinical studies described in this press release remain subject to change as a result of final data audit confirmation procedures to be conducted following completion of the studies; (v) the timing of the commencement or end of clinical studies and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (vi) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-214) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (vii) patents may not issue from our patent applications for our drug candidates including NKTR-214, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018.  Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Nektar Contacts:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
For Media:
Dan Budwick
1AB Media
973.271.6085
Bristol-Myers Squibb Contacts:
Media:
Audrey Abernathy, 919-605-4521
audrey.abernathy@bms.com
Investors:
Tim Power, 609-252-7509
timothy.power@bms.com
Bill Szablewski, 609-252-5894
william.szablewski@bms.com

View original content:http://www.prnewswire.com/news-releases/preliminary-data-for-nktr-214-in-combination-with-opdivo-nivolumab-for-patients-with-stage-iv-metastatic-melanoma-renal-cell-carcinoma-and-urothelial-cancers-presented-at-asco-2018-300658702.html
SOURCE Nektar Therapeutics; Bristol-Myers Squibb

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http://www.nektar.com

CAMBRIDGE, Mass., June 2, 2018 /PRNewswire-USNewswire/ — Why is it so hard to develop drugs for children with cancer? And what can be done about it?

Those questions are central to a new study published today in JAMA Oncology that explores new business models for funding drug development to treat pediatric cancers. The study, led by Andrew W. Lo, Charles E. and Susan T. Harris Professor at MIT and the director of the Laboratory for Financial Engineering, finds that a collaborative investment structure involving backing from the private sector, government, and philanthropic organizations holds the greatest promise for new drug discovery.
“As a new era of drug development dawns, scientists are finding cures and treatments for different types of cancers every day. But for a variety of reasons, childhood cancers are being left behind,” says Lo. “Spurring innovation in this field requires us to be more creative in our approach to financing. And if there is one patient population that really needs our support and advocacy, it’s our children.”
Even as our understanding of childhood cancers is growing and mortality rates are declining, pharmaceutical companies are facing significant disincentives in pursuing new treatments. For one thing, the market for these drugs is relatively small. Childhood cancer is a rare disease—only about 15,000 cases are diagnosed in the U.S. per year. Because it’s so rare, and because drug pricing is such a sensitive subject lately, pharmaceutical companies have fewer economic incentives to invest in pediatric oncology drug development.
Another factor is the scientific challenges in pediatric oncology due to the smaller number of genetic mutations in children that can serve as drug targets. Moreover, the biology of an infant is very different from that of an adolescent, which differs still from that of a young adult, making drug development even more complex for children. Also, because drug candidates sometimes have toxic side effects, pharmaceutical companies are reluctant to include children in clinical trials until safety has first been established in adults.
Finally, drug pricing remains a big obstacle. Lo and his co-authors—Sonya Das, an MIT undergraduate, Dr. Peter Adamson, Professor of Pediatrics and the Children’s Hospital of Philadelphia and Chair of Children’s Oncology Group, and Dr. Raphaël Rousseau, Chief Medical Officer at Gritstone Oncology—ran several simulations to evaluate the economic viability of a “multiple shots-on-goal” approach to therapeutic development in which many pediatric cancer projects are funded and developed simultaneously. The team found that a purely private-sector-funded portfolio of early-stage (Phase 1) projects produced expected returns ranging from −24.2% to 10.2%, depending on pricing assumptions, with the 10.2% figure requiring a $1 million price tag per course of treatment for each approved drug.
To make pediatric cancer drug development economically attractive for pharmaceutical companies, prices would need to range from several hundred thousand dollars to over a million dollars. “When lives are at stake, such lofty prices may seem like price gouging even though such prices may be justified from a cost-effectiveness perspective,” says Lo. “The political ramifications could be immense, so the issue is treated like a third rail— no one wants to touch it.”
To make progress in fighting these deadly childhood diseases, the study’s authors argue that a new way of funding pediatric drug development is needed. In further simulations involving philanthropic support, government guarantees, and portfolios of assets that include both late- and early-stage assets, the study reported expected returns ranging from –5.6% to 22.5%. “In the public/private partnership simulation, the private sector does the heavy lifting, but the so-called ‘Valley of Death’—the process of taking preclinical research through to Phase 1 clinical trials, where the financial risk is greatest—is taken on by government and charitable groups,” says Lo. “Philanthropic support helps pay for the R&D in the early stages and the government guarantee reduces the downside risk of investment at a reasonably low cost to taxpayers. This is the kind of collaborative approach that’s needed to make pediatric cancer drug development attractive to investors and the private sector.”
To encourage other researchers and practitioners to experiment with and extend their analysis, the authors published the full details of the simulations in the supplementary materials that accompany the article. The team also made all of their computer code open- source and freely available.
“Our hope is that government agencies, policymakers, philanthropists, drug companies, and investors will be motivated to action by our findings,” he says. “Treating childhood cancer is a nonpartisan issue, and under the right financing and business structures, we can do well by doing good.”
View original content with multimedia:http://www.prnewswire.com/news-releases/new-study-by-mit-sloan-researchers-provides-insights-on-the-challenges-of-developing-drugs-for-pediatric-cancerand-offers-a-potential-solution-300658197.html
SOURCE MIT Sloan School of Management

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http://www.mitsloan.mit.edu

WASHINGTON, June 2, 2018 /PRNewswire/ — This week, justice and recovery professionals fighting the nation’s battle against the opioid epidemic have convened in Houston for the National Association of Drug Court Professionals (NADCP) annual conference.
In an inaugural scholarship program through its Law Enforcement & Medical Response Line of Operation, S.A.F.E. Project US (Stop the Addiction Fatality Epidemic) provided three opportunities for law enforcement professionals to gain education, training and a network of support in the addiction epidemic.

“Law enforcement professionals are on the front lines of the addiction crisis in our country, and having them embrace a response that doesn’t rely on arrests and incarceration begins with education,” said S.A.F.E. Project US Co-Chair Admiral Sandy Winnefeld. “Offering training to members of law enforcement is a critical component to the S.A.F.E. Project US strategy, and we are grateful to our partners at NADCP for working with us to identify this opportunity.”
The scholarships were presented to two Deputy Sheriffs of the Harris County Sheriff Department (PA), and a Sergeant of the Houston Police Department.  They were chosen based on the needs of their departments and their roles in the opioid crisis, with a keen focus on community involvement.
The program is aimed at filling the gap in education and training opportunities afforded law enforcement on the front lines of the opioid epidemic, while also fundamentally changing how law enforcement views their interactions with those suffering from substance use disorder. Sponsoring Law Enforcement officers to attend training on best practice policing, the science of addiction and innovative pre-trial and post-arrest diversion programs, is a major step in the organization’s nationwide “S.A.F.E. Communities” initiative. 
“The scholarships provided by S.A.F.E Project US help ensure law enforcement have the training they need to respond to the opioid epidemic. NADCP is honored to partner with the S.A.F.E. Project US as we continue to ensure people struggling with opioid use disorder have access to life-saving treatment,” said NADCP CEO Carson Fox.  
The scholarship recipients will return to their departments and share what they learned with their law enforcement colleagues, and continue to work with the S.A.F.E. Project US team to identify opportunities to share what they’ve learned with other departments, and future potential scholarship recipients.
“Ultimately, S.A.F.E. Project US hopes to increase the number of law enforcement agencies proactively engaging with their communities to both decrease drug supply and demand in this national crisis,” concluded ADM Winnefeld.
Admiral and Mrs. Winnefeld will recognize the scholarship recipients at the conference closing ceremonies on June 2.
S.A.F.E. (Stop the Addiction Fatality Epidemic) is a non-governmental organization that is committed to contributing in a tangible way to overcoming the epidemic of opioid addiction in the United States.
Contact: Tracey Lynn Shifflett
301.602.8688
mTracey@safeproject.us
View original content:http://www.prnewswire.com/news-releases/safe-project-us-invests-in-law-enforcement-training-for-opioid-response-300658684.html
SOURCE S.A.F.E. Project US

NEW YORK, June 2, 2018 /PRNewswire/ — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Allegiant Travel Company (NASDAQ: ALGT) from June 8, 2015 through April 13, 2018, both dates inclusive (“Class Period”) of the important June 25, 2018 lead plaintiff deadline in the first-filed case commenced by the Rosen Law Firm. The lawsuit seeks to recover damages for Allegiant investors under the federal securities laws.

To join the Allegiant class action, go to http://www.rosenlegal.com/cases-1325.html or call Phillip Kim, Esq. or Zachary Halper, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or zhalper@rosenlegal.com for information on the class action.
NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. YOU MAY RETAIN COUNSEL OF YOUR CHOICE
According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Allegiant lacked adequate systems to ensure its aircraft were being properly maintained; (2) consequently, Allegiant was not operating responsibly and ethically, and providing safe working conditions for its employees; and (3) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than June 25, 2018. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-1325.html to join the class action. You may also contact Phillip Kim or Zachary Halper of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or zhalper@rosenlegal.com.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm.
Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Attorney Advertising.  Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
Zachary Halper, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 34^th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
zhalper@rosenlegal.com 
www.rosenlegal.com
View original content with multimedia:http://www.prnewswire.com/news-releases/algt-shareholder-notice-rosen-law-firm-reminds-allegiant-travel-company-investors-of-important-deadline-in-first-filed-class-action-algt-300658481.html
SOURCE Rosen Law Firm, P.A.

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http://www.rosenlegal.com

BERWYN, Pa., June 2, 2018 /PRNewswire/ — RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased PPG Industries, Inc. (NYSE: PPG) (“PPG” or the “Company”) publicly traded securities between April 24, 2017 and May 10, 2018, inclusive (the “Class Period”).

PPG shareholders may, no later than July 19, 2018, move the Court for appointment as a lead plaintiff of the Class.  If you purchased shares of PPG and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
PPG manufactures and distributes paints, coatings, and specialty materials in the United States and internationally.
The Class Period commences on April 24, 2018, when the company filed a Form 10-Q for the quarter ended March 31, 2017 with the SEC, which provided the company’s first quarter 2017 financial results and position. On April 19, 2018, after market-close, PPG issued a press release entitled ”PPG reports first quarter 2018 financial results,” disclosing that the company received a report concerning potential violations of its accounting policies and identifying certain expenses that should have been accrued in the first quarter.  Following this news, the company’s shares fell $0.77 or 0.7% to close at $108.87 on April 20, 2018.
Then, on May 10, 2018, after market-close, PPG issued a press release entitled ”PPG provides update on Form 10-Q filing and internal investigation,” disclosing that: 1) PPG’s Audit Committee found evidence that improper accounting entries were made by certain employees at the direction of PPG’s former Vice President and Controller; 2) PPG’s Former Vice President was terminated as of May 10, 2018; 3) PPG would be unable to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018; and 4) PPG’s financial statements for the 2017 year should not be relied upon.  Following this news, the company’s shares fell $5.68 or over 5% to close at $100.43 on May 11, 2018.
If you are a member of the class, you may, no later than July 19, 2018, request that the Court appoint you as lead plaintiff of the class.  A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation.  In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class.  Under certain circumstances, one or more class members may together serve as “lead plaintiff.”  Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff.  You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.
For more information regarding this, please contact RM LAW, P.C.  (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here.   For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here.
RM LAW, P.C. is a national shareholder litigation firm.  RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.
CONTACT:
RM LAW, P.C.
Richard A. Maniskas, Esquire
1055 Westlakes Dr., Ste. 300
Berwyn, PA 19312
484-324-6800
844-291-9299
rm@maniskas.com
View original content with multimedia:http://www.prnewswire.com/news-releases/rm-law-announces-class-action-lawsuit-against-ppg-industries-inc-300658681.html
SOURCE RM LAW, P.C.

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http://www.rmclasslaw.com

BERWYN, Pa., June 2, 2018 /PRNewswire/ — RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased QuinStreet, Inc. (NASDAQ: QNST) (“QuinStreet” or the “Company”) publicly traded securities between February 10, 2016 and April 10, 2018, inclusive (the “Class Period”).

QuinStreet shareholders may, no later than June 26, 2018, move the Court for appointment as a lead plaintiff of the Class.  If you purchased shares of QuinStreet and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
QuinStreet, an Internet performance marketing and media company, provides customer acquisition services for its clients in the United States and internationally. It offers online marketing services to its clients in the form of qualified leads, inquiries, clicks, calls, applications, customers, display advertisements, or impressions through its Websites or third-party publishers.
The complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that (i) QuinStreet recklessly disregarded the occurrence of click-through fraud; (ii) QuinStreet-owned websites experienced phony, low-quality traffic for its clients; (iii) the Company’s practices were not geared toward providing its clients with valuable customers or high-quality leads or clicks; (iv) the Company’s fiscal 2018 financial guidance was overstated; and (v) as a result of the foregoing, QuinStreet’s public statements were materially false and misleading at all relevant times.
If you are a member of the class, you may, no later than June 26, 2018, request that the Court appoint you as lead plaintiff of the class.  A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation.  In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class.  Under certain circumstances, one or more class members may together serve as “lead plaintiff.”  Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff.  You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.
For more information regarding this, please contact RM LAW, P.C.  (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here.   For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here. 
RM LAW, P.C. is a national shareholder litigation firm.  RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.

View original content with multimedia:http://www.prnewswire.com/news-releases/rm-law-announces-class-action-lawsuit-against-quinstreet-inc-300658678.html
SOURCE RM LAW, P.C.

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http://www.rmclasslaw.com

PROVIDENCE, R.I., June 2, 2018 /PRNewswire-USNewswire/ — This morning, Rhode Island School of Design (RISD) awarded degrees to 463 undergraduate and 208 graduate students at its 135th Commencement ceremony. Commencement 2018 took place at the Rhode Island Convention Center in downtown Providence. On behalf of Hanson, Sophia delivered the keynote address urging students “to bring to the world a different kind of dream—a dream that wakes people up to their better selves.” Watch the full address.

This year RISD presented two honorary Doctor of Fine Arts degrees to visionaries in contemporary culture. Photographer Annie Leibovitz and artist Cai Guo-Qiang accepted honorary degrees at the ceremony. Hanson Robotics founder and RISD alumnus David Hanson (RISD ’96 Film/Animation/Video) was honored with the 2018 Alumni Award for Artistic Achievement.
David Hanson | Alumni Award for Artistic Achievement + keynote speaker
As founder and CEO of Hanson Robotics, David Hanson 96 FAV has built a worldwide reputation for creating the world’s most humanlike, empathetic robots, endowed with remarkable expressiveness, aesthetics and interactivity. His work in this realm has received widespread media attention and public acclaim.
With a BFA in Film/Animation/Video from RISD and a PhD in interactive arts and engineering from the University of Texas at Dallas, Hanson publishes regularly in materials science, artificial intelligence, cognitive science and robotics journals, and has been featured in numerous popular media outlets including The New York Times, Popular Science, Scientific American, the BBC and CNN. Dubbed a “genius” by both PC Magazine and WIRED, he has earned awards from NASA, the National Science Foundation and the Cooper Hewitt, among many others.
Cai Guo-Qiang | honorary degree
Now based in New York, Chinese-born artist Cai Guo-Qiang works across several disciplines, including drawing, installation, video and performance. He is best known for his signature “explosion events” and paintings made by detonating gunpowder. Through these works the artist says he’s “attempting to achieve a sense of the eternal from the ephemeral.”
Cai’s work has been featured in solo exhibitions at the Metropolitan Museum of Art and the Guggenheim, which hosted the 2008 retrospective I Want to Believe. In 2012 he earned the prestigious Praemium Imperiale from the Japan Art Association and was among five artists to receive the first US Department of State Medal of Arts award for his commitment to international cultural exchange. In 2016 Academy Award winner Kevin Macdonald further illuminated Cai’s life and work in the Netflix documentary Sky Ladder: The Art of Cai Guo-Qiang. The artist is also the father of RISD alumna Wen-You Cai, who graduated in 2012 with a BFA in Sculpture.
Annie Leibovitz | honorary degree
Over the course of her career, Annie Leibovitz has produced a large and distinguished body of work that encompasses some of the most well-known portraits of our time. She began her work as a photojournalist for Rolling Stone in 1970, while she was still a student. By the time she joined the staff of the revived Vanity Fair in 1983, she had established herself as the foremost rock music photographer and an astute documentarian of the social landscape. At Vanity Fair and later at Vogue, her work with actors, directors, writers, musicians, athletes and political and business figures—as well as her fashion photographs—expanded her collective portrait of contemporary life.
Leibovitz has published several books and has exhibited widely. She is a Commandeur in the French government’s Ordre des Arts et des Lettres and has been designated a Living Legend by the Library of Congress.
Risë Wilson | graduate hooding speaker
For two decades social entrepreneur Risë Wilson has been a powerful voice for the arts as a catalyst for change and community building. Currently the chief program officer for The High Line, a public park and cultural center on Manhattan’s West Side, she is known for founding The Laundromat Project in 1998. The New York-based nonprofit stages public arts projects in laundromats throughout Harlem, the South Bronx and other areas of city, inspiring people to not just view art but also “reconsider their own neighborhoods [by] discovering art in unexpected places.”
Wilson’s work in arts and culture advocacy extends to previous roles at the Robert Rauschenberg Foundation, MoMA and Parsons. She holds a BA from Columbia University, where she was a Kluge Scholar, and an MA from NYU, where she was a MacCracken Fellow.
RISD’s joyous Commencement ceremony offers a festive culmination to years of creative exploration in the studio. Students traditionally transform their caps and gowns in idiosyncratic ways—by painting, reimagining and embellishing them to make a more personal artistic statement or simply to have fun with this colorful RISD tradition. For more information on RISD’s 2018 Commencement and to view the ceremony streaming live on June 2, visit commencement.risd.edu.
On Friday, June 1 social entrepreneur and community organizer Risë Wilson spoke at the Graduate hooding ceremony as part of Commencement celebrations.
A series of exhibitions leading up to Commencement highlighted new work produced by graduating students, including the Senior Invitational Exhibition at Woods-Gerry Gallery, the RISD graduate thesis exhibition at the RI Convention Center, a selection of graduate student works at Sol Koffler Gallery and the Senior Film/Animation/Video Festival at the RISD Auditorium. A student-curated exhibition of undergraduate and graduate student work is also on view at the Gelman Student Exhibitions Gallery in the Chace Center.
About Rhode Island School of Design
Known as the leading college of art and design in the United States, Rhode Island School of Design (RISD) is ranked #1 in Business Insider‘s survey of The World’s 25 Best Design Schools. Approximately 2,450 students from around the world are enrolled in full-time bachelor’s or master’s degree programs in a choice of 19 majors. Students value RISD’s accomplished faculty of artists and designers, the breadth of its specialized facilities and its hands-on approach to studio-based learning. Required courses in the liberal arts enrich the studio experience, equipping graduates to make meaningful contributions to their communities. Through their creative thinking and problem solving in a broad range of fields, RISD’s 26,000 alumni exemplify the vital role artists and designers play in fueling global innovation. Founded in 1877, RISD (pronounced “RIZ-dee”) and the RISD Museum help make Providence, RI among the most culturally active and creative cities in the region. For more information, visit risd.edu and our.risd.edu.

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SOURCE Rhode Island School of Design

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EAST HANOVER, N.J., June 2, 2018 /PRNewswire/ — New Novartis data from two long-term Treatment-free Remission (TFR) studies in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) will be presented during the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Results from the open-label Phase II trials, ENESTop and ENESTfreedom, show sustained TFR in patients treated with both front-line and second-line Tasigna^® (nilotinib) therapy. The 144-week trials evaluate the potential to maintain molecular response (MR) after stopping therapy in eligible adult patients with Ph+ CML-CP.

“Treatment-free Remission is a new treatment goal in CML,” said François-Xavier Mahon, Cancer Center of Bordeaux, Institut Bergonié and lead investigator of ENESTop. “Clinical studies like ENESTop and ENESTfreedom offer evidence that when a Ph+ CML-CP patient achieves a deep molecular response with Tasigna, along with other eligibility criteria, s/he can attempt TFR and have a nearly 50% chance of remaining treatment-free long-term. These results confirm an exciting opportunity for eligible patients – the opportunity to reduce time on drug for a chronic leukemia.”
Data from ENESTop, presented today in an oral session (Abstract #7003) show that approximately half (48.4%; CI 95%, 39.4%-57.5%) of patients with Ph+ CML-CP who are eligible to stop second-line Tasigna therapy maintained disease remission over a prolonged period of time in the absence of treatment at 144 weeks of follow up, almost 3 years¹. Patients in this trial took Tasigna following a switch from Gleevec^® (imatinib mesylate)*. ENESTop data also show that of the patients who restarted Tasigna due to loss of major molecular response (MMR=BCR-ABL/ABL <=0.1% IS), during the study period, nearly all (97.1%) regained MMR and 95.8% regained MR^4.5 (BCR-ABL1 IS ≤ 0.0032%)¹. Study authors stress that frequent scheduled and compliant monitoring is necessary to assess for loss of response. Results of ENESTop at 144-weeks are consistent with previously reported data at both 96- and 48-weeks.
A second long-term clinical trial, ENESTfreedom, is also part of the ASCO Scientific Program this week. The authors will report on TFR results at 144 weeks in patients who started front-line CML therapy with Tasigna. Results from ENESTfreedom will be shared with ASCO attendees on Monday, June 4 (Abstract #7063). In this trial, researchers found that almost half (46.8%; CI 95%: 39.6%-54.2%) of Ph+ CML-CP patients eligible to stop Tasigna treatment remained in MMR following treatment discontinuation².
“Novartis continues to redefine treatment options for Ph+ CML patients,” said Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development. “The importance of achieving deep and sustained responses with Tasigna has been demonstrated in our TFR clinical program, which is the largest among all oncology companies. These long-term trials deliver on our commitment to the patient community to continue to look for more and better solutions for CML.”
An update on the Phase III clinical trial design for Novartis’ investigational BCR-ABL1 inhibitor, asciminib, will also be presented as part of the ASCO Scientific Program (Abstract #TPS7081). 
Novartis Commitment to CML
Novartis’ ongoing research in Ph+ CML has helped transform the disease from a fatal leukemia to a chronic condition in most patients. The company maintains an unwavering commitment to scientific innovation and access to care for patients worldwide. As an organization committed to patients, Novartis continues to reimagine CML by pursuing ambitious goals with courage, passion and commitment for the global CML community.
About ENESTop
ENESTop (Evaluating Nilotinib Efficacy and Safety Trial) is an open label Phase II study involving 163 Ph+ CML patients, conducted at 63 sites across 18 countries. The trial evaluated stopping treatment in 126 adults with Ph+ CML-CP receiving Tasigna for at least three years, after patients had achieved and sustained deep molecular response (DMR) for one year with Tasigna following Gleevec. The study is ongoing with planned follow-up to evaluate the ability of patients to sustain remission for longer durations upon discontinuation of Tasigna.
Findings from ENESTop at 144-weeks found that 48.4% (CI 95%, 39.4%-57.5%) of 126 patients were able to remain in TFR at 144 weeks¹. In the study, 58 patients with confirmed loss of MR⁴ (n=24; BCR-ABL1 IS ≤ 0.01%) or loss of MMR (n=34) restarted Tasigna by the cut-off date¹. Of the 34 patients who restarted treatment with Tasigna due to loss of MMR, 91.2% regained MR^4.5 (n=31; BCR-ABL1 IS ≤ 0.0032%)¹. Of the 24 patients with loss of MR⁴ who restarted Tasigna, 95.8% (n=23) regained MR^4.5,1. No new major safety findings were observed in ENESTop in patients treated with Tasigna beyond those in the known safety profile of Tasigna¹. Among patients who remained in the TFR phase of the trial for more than 96 weeks (n=68), 10.3%, 51.5%, 19.1%, and 11.8% experienced any-grade musculoskeletal pain–related adverse events in the consolidation phase and first, second, and third 48-week phases of TFR, respectively¹.
About ENESTfreedom
ENESTfreedom (Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Following REsponsE in De nOvo CML-CP Patients) is an open label Phase II study involving 215 Ph+ CML patients in the chronic phase, conducted at 132 sites across 19 countries. ENESTfreedom evaluated stopping treatment in 190 adults with Ph+ CML-CP receiving Tasigna for at least three years, after the patients had achieved a response of MR^4.5 with Tasigna and a sustained DMR for one year as a first-line treatment. The study is ongoing with planned follow-up to evaluate the ability of patients to sustain remission for longer durations following discontinuation of Tasigna.
Findings from ENESTfreedom at 144-weeks found that 46.8% of 190 eligible CML patients (CI 95%: 39.6%-54.2%) remained in MMR following discontinuation of Tasigna². Of the 91 patients who restarted treatment with Tasigna due to loss of MMR by the cut-off date, 98.9% (n=90) and 92.3% (n=84) were able to regain MMR and MR4.5, respectively². No new major safety findings were observed in ENESTfreedom in patients treated with Tasigna beyond those in the known safety profile of Tasigna². Among patients who remained in TFR for more than 96 weeks (n=94), any-grade musculoskeletal pain-related AEs were 16.0%, 40.4%, 9.6% and 4.3% in the consolidation phase and first, second and third 48-week phases of TFR, respectively².
About Tasigna
Tasigna (nilotinib) is approved in more than 130 countries for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in chronic phase and with chronic and accelerated phase Ph+ CML resistant or intolerant to at least one prior therapy, including Gleevec (imatinib mesylate). Tasigna is also approved for the treatment of pediatric patients with newly diagnosed Ph+ CML in the chronic phase and with resistance or intolerance to prior TKI therapy.
IMPORTANT SAFETY INFORMATION for TASIGNA^® (nilotinib) Capsules
Tasigna can cause QT prolongation, a possible life-threatening heart problem. Patients with long QTc syndrome or low levels of potassium or magnesium should not take Tasigna. Obtain a baseline ECG prior to initiating therapy and as clinically indicated. Monitor closely for an effect on the QTc interval. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Cases of sudden death have been reported in clinical studies in patients with significant risk factors. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Avoid food 2 hours before and 1 hour after taking dose.
Use with caution in patients with liver impairment, with a history of pancreatitis and with total gastrectomy. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not use Tasigna. Tasigna may cause fetal harm in pregnant women. If pregnancy is planned during the treatment-free remission phase, the patient must be informed of a potential need to re-initiate treatment with Tasigna during pregnancy. Women should not breastfeed while taking Tasigna and for 2 weeks after the last dose.
Cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive disease, and ischemic cerebrovascular events have been reported. Serious cases of hemorrhage from various sites including gastrointestinal were reported in patients receiving Tasigna. Grade 3 or 4 fluid retention including pleural effusion, pericardial effusion, ascites and pulmonary edema have been reported. Cases of tumor lysis syndrome have been reported in Tasigna-treated patients who were resistant or intolerant to prior CML therapy.
Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation (TFR) must be performed with a diagnostic test validated to measure at least MR^4.5. After discontinuation of Tasigna, frequently scheduled patient monitoring of BCR-ABL transcript levels is required to detect possible loss of remission. Loss of MMR in first line or confirmed loss of MR⁴ (2 consecutive measures separated by at least 4 weeks showing loss of MR⁴) in second line will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred. For patients who fail to achieve MMR after 3 months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Musculoskeletal pain, myalgia, pain in extremity, arthralgia, bone pain and spinal pain may occur upon discontinuing treatment with Tasigna within the framework of attempting treatment-free remission.
The most frequent Grade 3 or 4 adverse events in adults are hematological (neutropenia, thrombocytopenia, anemia) which are generally reversible and usually managed by withholding Tasigna temporarily or dose reduction. Chemistry panels, including electrolytes, lipid profile, liver enzymes, and glucose should be checked prior to therapy and periodically. Tasigna can cause increases in serum lipase. The most frequent non-hematologic adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea.
Tasigna may result in hepatotoxicity as measured by elevations in bilirubin, AST, ALT, and alkaline phosphatase. Grade 3-4 elevations of bilirubin, AST, and ALT were reported at a higher frequency in pediatric than in adult patients. Monitor hepatic function tests monthly or as clinically indicated.
Adverse reactions observed in pediatrics were generally consistent with those observed in adults. Two Grade 3 or 4 laboratory abnormalities, hyperbilirubinemia and transaminase elevation were reported at a higher frequency in children. The long-term effects of prolonged treatment with Tasigna on growth and development in children treated for chronic phase Ph+ CML are unknown.
Please see full Prescribing Information including Boxed WARNING at https://www.us.tasigna.com/.
About asciminib
Asciminib (ABL001) is an investigational compound. Efficacy and safety have not been established. There is no guarantee this compound will become commercially available.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
*Known as Glivec^® (imatinib) outside the US and Canada.
References

1. Mahon, F.X. et al. Long-term treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib: ENESTop 144-wk results. Abstract #7003. 2 June 2018 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, IL.
2. Radich, J. P. et al. Long-term treatment-free remission (TFR) following frontline (1L) nilotinib in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENESTfreedom 144-wk results. Abstract #7063. 4 June 2018. American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, IL.

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SOURCE Novartis

BERWYN, Pa., June 2, 2018 /PRNewswire/ — RM LAW, P.C. has commenced an investigation into potential securities law violations by certain officers of FleetCor Technologies, Inc. (“FleetCor” or the “Company”) (NYSE: FLT).
If you purchased shares of FleetCor and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.

On December 19, 2016, the Company’s largest U.S. customer, Chevron, terminated its 10-year relationship with the Company. Then, beginning in March 2017, numerous news and analyst reports revealed allegations against the Company for a pattern of misconduct involving fraudulent billing, misleading marketing and predatory sales tactics. In May 2017, Chevron filed a breach of contract lawsuit against the Company relating in part to the Company’s mistreatment of customers. Further, between May 10, 2016 and March 10, 2017, the Company’s President/CEO/Chairman, CFO and four other directors disposed of 685,720 shares of FleetCor stock at artificially inflated prices, receiving over $108 million in proceeds.
Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws. Recently, the U.S. District Court presiding over that case denied the Company’s motion to dismiss in part, allowing the case to move forward.
For more information regarding this, please contact RM LAW, P.C.  (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here.   For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here. 
RM LAW, P.C. is a national shareholder litigation firm.  RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.
CONTACT:
RM LAW, P.C.
Richard A. Maniskas, Esquire
1055 Westlakes Dr., Ste. 300
Berwyn, PA 19312
484-324-6800
844-291-9299
rm@maniskas.com 
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SOURCE RM LAW, P.C.

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Breakthrough in Nigeria paves the way for accelerated growth in African market
ABUJA, Nigeria, June 2, 2018 /PRNewswire/ — GAC Motor has officially delivered 150 GA3Ss to Nigerian police force in Nigerian capital city of Abuja, which were purchased and donated by Alhaji Aliko Dangote, Chairman of Aliko Dangote Foundation. This is the second time that the company has delivered cars to Nigerian police, after an initial order from the Lagos police department in 2015. The bulk order is further recognition of GAC Motor’s growth in the African market, and affirmation of the excellent quality and high safety standards of its vehicles. The delivery ceremony was attended by distinguished guests including Yemi Osinbajo, Vice President of Nigeria.

“GAC Motor has successfully brought a variety of signature models to Nigeria, gaining bulk purchase orders from local governments for showing its quality and positive brand image. This latest cooperation will accelerate our further development in the Nigerian market,” said Yu Jun, President of GAC Motor.
The Nigerian police spoke highly of the powerful and intelligent design and excellent safety features of GA3S. It is believed that the model’s style, design and customized smart safety features can be adapted to the complex requirements of police cars.
To better adapt to market developments in Africa, GAC Motor is constantly optimizing vehicle designs based on local road conditions to guarantee reliable quality and performance. Most models have been specifically adjusted to meet the requirements of performing on bumpy and muddy roads, such as by adding higher chassis to improve passing clearance. With its excellent product quality and high adaptability to the African market, GAC Motor won the favor of local consumers and has been the best-selling Chinese brand in Nigeria.
GAC Motor achieved its market success by sticking to its quality-first principle. For five years in a row, GAC Motor has been ranked first among all Chinese brands in J.D. Power Asia’s IQS study. GS8, the most popular model in Nigeria, is rated five-star by C-NCAP (China-New Car Assessment Program). It has also established strategic partnerships with the world’s top suppliers and recruited top talent to strictly monitor quality, which will boost the company’s expansion in the African market and the world at large.
Noteworthy milestones for GAC Motor in African market

• Opened the first dealer shop in Nigeria in December 2014, and a second two years later.
• In 2016, GAC Motor established a SKD (semi knocked-down) factory in Nigeria, becoming the first Chinese auto brand to have parts assembled locally.
• In 2017, the Nasarawa State government made a bulk purchase of GS8s, GS4s and GA3Ss as official reception vehicles.
• In February 2018, GAC Motor’s signature model GS8 was launched in Nigeria.

Nigeria is one of the most important markets in GAC Motor’s growth strategy for Africa, which includes developing its local management team, the release of localized versions of its top models, and a factory on the ground that enables the automaker to achieve continuous breakthroughs in the market.
Achieving a solid foundation in Nigeria, a participating country in China’s “Belt and Road” Initiative, will allow GAC Motor to more effectively reach the greater African market, and to push forward its brand internationalization.
About GAC Motor
Founded in 2008, Guangzhou Automobile Group Motor CO., LTD (GAC Motor) is a subsidiary of GAC Group which ranks the 238th among the Fortune Global 500 companies. The company develops and manufactures premium quality vehicles, engines, components and auto accessories. GAC Motor has now ranked the first among all Chinese brands for five consecutive years in J.D. Power Asia Pacific’s China Initial Quality Study SM (IQS), demonstrating the company’s quality-centric strategy from innovative research and development (R&D), manufacturing to supply chain and sales & services.
For more information, please visit:
Facebook: https://www.facebook.com/GACMotor
Instagram: https://www.instagram.com/gac_motor
Twitter: https://www.twitter.com/gac_motor
Media Contact:
Sukie Wong
+86-186-8058-2829
GACMotor@126.com
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SOURCE GAC Motor

TOKYO, June 2, 2018 /PRNewswire/ — Shiseido Company, LTD commemorated the re-launch of its hero serum, Ultimune Power Infusing Concentrate with simultaneous celebrations all around the globe. Kicking off in Paris on May 31st the festivities continued in Tokyo, Hong Kong, Taipei, Bangkok and Singapore, culminating in Malibu, USA on June 1st. In partnership with internationally celebrated dance artist and choreographer, Koharu Sugawara, each event focuses on the virtue of inner strength, the confidence it instills, and the joy it brings.

With Ultimune Power Infusing Concentrate taking center stage, this series of events represents a significant milestone in SHISEIDO’s brand rejuvenation journey, underpinning the brand’s VISION 2020.
Shortly after its inaugural launch in 2014, Ultimune Power Infusing Concentrate cemented its status as the best-selling product in the SHISEIDO range, with one bottle sold every 13 seconds.* This game-changing serum has received over 132 beauty awards globally** – more than any other product in SHISEIDO’s portfolio in the course of the brand’s 145-year history. Ultimune Power Infusing Concentrate was developed with an uncompromising commitment to fortifying the skin’s inner defenses, and the global #StrongSouls campaign is a motivating expression of the product’s end promise. A salute to the inner strength of every individual, #StrongSouls invites each of us to embrace our own convictions, our personal power and the empathy that unites us with others, through these shared celebrations and the sense of positivity they evoke.
Marrying Art with Grace and Strength
With its inspiring imagery, the #StrongSouls campaign taps into both SHISEIDO‘s enduring heritage as a distinguished beauty brand, and its position as a progressive voice for women. The campaign film is shaped by the dance artistry of Koharu Sugawara as she moves through the city of Tokyo. Through dance, she conveys a story of deep emotion and with calculated nuance, she draws from her own inner and outer strength to create the ultimate expression of joy and power.
Celebrate the power of inner strength and share in the joy that it brings with Koharu Sugawara at https://youtu.be/ELYYRQkCYzc
For more event images, please follow SHISEIDO at www.instagram.com/shiseido/
To go behind-the-scenes, please visit https://www.image.net/ultimune_strongsouls2018
*Based on global sell-in data collected from January 2017–December 2017, in which 1 day is counted as 24 hours
**Total number of awards globally as of December 2017
Shiseido Brand Unit
Hiroko Ozeki
hiroko.ozeki@to.shiseido.co.jp
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SOURCE Shiseido Co Ltd

NEW ORLEANS, June 1, 2018 /PRNewswire/ — ClaimsFiler, a FREE shareholder information service, reminds investors that they have until June 2, 2018 to file lead plaintiff applications in a securities class action lawsuit against LendingClub Corporation (NYSE: LC), if they purchased the Company’s securities between February 28, 2015 and April 25, 2018, inclusive (the “Class Period”).  This action is pending in the United States District Court for the Northern District of California.
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NEW ORLEANS, June 1, 2018 /PRNewswire/ — Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Caterpillar, Inc. (NYSE: CAT).  

On March 2, 2017, multiple federal law enforcement agencies executed search warrants in a raid of Caterpillar’s offices, which the Company stated was related to “export filings” for its Swiss subsidiary. Media reports alleged that the raids were “related to potential crimes, including ‘failure to file or submitting false electronic export information’ and ‘false and misleading financial reports and statements'” and that a report commissioned by the federal government accused Caterpillar of tax and accounting fraud, avoiding federal income taxes on billions of dollars of offshore money, to boost its stock price.
Thereafter, Caterpillar and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws, which is ongoing.  On October 10, 2017, the Company filed a motion to dismiss the suit, which is presently under consideration by the court.
KSF’s investigation is focusing on whether Caterpillar’s officers and/or directors breached their fiduciary duties to Caterpillar’s shareholders or otherwise violated state or federal laws. 
If you have information that would assist KSF in its investigation, or have been a long-time holder of Caterpillar shares, and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nyse-cat/ to learn more.
About Kahn Swick & Foti, LLC
KSF, whose partners include the Former Louisiana Attorney General Charles C. Foti, Jr., is a law firm focused on securities, antitrust and consumer class actions, along with merger & acquisition and breach of fiduciary litigation against publicly traded companies on behalf of shareholders. The firm has offices in New York, California and Louisiana.
To learn more about KSF, you may visit www.ksfcounsel.com.
Contact:
Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
lewis.kahn@ksfcounsel.com
1-877-515-1850
206 Covington St.
Madisonville, LA 70447

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SOURCE Kahn Swick & Foti, LLC

Related Links

http://www.ksfcounsel.com

LOS ANGELES, June 2, 2018 /PRNewswire/ — Last night, “Orange is the New Black” actress Laverne Cox hosted a special lighting ceremony at Beverly Center ceremoniously flipping the switch to bathe the center’s exterior in PRIDE’s signature rainbow colors as a symbol of the center’s ongoing support of the LGBTQ community.
Held at Farmhouse restaurant, the ceremony was held in honor of The Advocate’s Champions of PRIDE event that honored notable LGBTQ advocates and allies who have made a significant impact on their community over this past year.

“Beverly Center has welcomed and supported the LGBTQ community since it opened its doors in 1982,” said Taubman Centers, Inc. Chief Executive Officer William S. Taubman. “This year, we are proud to be partnering with The Advocate to host the Champions of PRIDE event, as well as light the center in PRIDE’s signature rainbow colors.”
Beverly Center’s new lights were installed as part of the center’s $500 million reimagination that is scheduled to be completed by Holiday 2018. The newly installed exterior mesh, over which the lights are projected, covers 95,000 sq. ft. More than 670 custom projectors and over 34,000 LED diodes are able to create four billion colors – more than the human eye can distinguish.
This marks the first of many holidays Beverly Center plans to light the building throughout the year including July 4^th, Halloween, winter holiday, Valentine’s Day and more. 
About Beverly Center
Beverly Center is Southern California’s premier fashion destination with more than 100 distinctive specialty boutiques reflecting the diverse styles and tastes of Los Angeles, including a paramount portfolio of luxury retailers such as Burberry, Dolce & Gabbana, Fendi, Gucci, Louis Vuitton, Prada, Saint Laurent and Salvatore Ferragamo. The Center is anchored by Bloomingdale’s and Macy’s. The unique assortment of point-of-difference stores like COS, Henri Bendel and Traffic, paired with the expanded fast fashion collection comprised of Uniqlo, H&M and XXI Forever and contemporary brands Sandro, Maje and Zara make Beverly Center the ultimate shopping experience.
View original content with multimedia:http://www.prnewswire.com/news-releases/beverly-center-shows-its-pride-by-lighting-exterior-in-rainbow-colors-300658664.html
SOURCE Beverly Center

MISSOULA, Mont., June 2, 2018 /PRNewswire-USNewswire/ — The National Forest Foundation (NFF) and REI are joining forces again in 2018 to improve National Forests across America. In 2017, REI supported $1 million worth of work on America’s National Forests and Grasslands — from the Tongass National Forest in Alaska to Midewin National Tallgrass Prairie near Chicago. REI’s support generated significant positive benefits for our National Forests, including:

• More than 66 miles of trail restoration and maintenance,
• More than 660 volunteers engaged on projects,
• More than 16,627 volunteer hours dedicated to projects,
• 17 campsites maintained or improved,
• More than 1,200 acres of wildlife habitat restored or maintained.

In 2018, REI will donate up to $1 million to the NFF through the REI members-only REI Co-op World Mastercard®. With every purchase made on the REI Co-op Mastercard^®, REI makes a donation to the National Forest Foundation¹. This year is also the 50^th Anniversary of the National Scenic Trails Act, making 2018’s slate of projects that focus largely on restoring, maintaining and building trails on National Forests especially relevant.
“Access to quality trails is key to a life outdoors,” said Taldi Walter, REI community and government affairs manager. “As we celebrate 50 years of the National Scenic Trails Act, we’re grateful for partners like the National Forest Foundation who are working to improve access in America’s national forests and ensure these spaces remain accessible for all.”
Projects in 2018 will help repair damage that 2017’s hurricane season wreaked on National Forests in Texas and Florida including trail restoration on the Sam Houston National Forest and on the Ocala National Forest. Additional projects include:

• Trail restoration in the Seneca Rocks – Spruce Knob National Recreation Area on the Monongahela National Forest in West Virginia;
• Pairing midshipmen from the U.S. Naval Academy with volunteer crews to conduct wilderness restoration in the George Washington-Jefferson National Forest in Virginia;
• Building more than six miles of new trail for mountain bikers, trail runners and hikers on the Tahoe National Forest in California;
• Working with Native American youth from Oklahoma on forest restoration and archeological projects in Georgia’s Chattahoochee-Oconee National Forest;
• Repairing and rerouting trails on popular peaks in Colorado’s Rocky Mountains, including Pikes Peak;
• Trail restoration and trailhead improvements in the San Gabriel Mountains National Monument,
• Trail restoration and trailhead improvements on the Mount Baker-Snoqualmie National Forest in Washington.

“REI’s commitment to our National Forests is truly extraordinary,” said Mary Mitsos, NFF president. “Today is National Trails Day and we couldn’t find a better opportunity to express our appreciation for the leadership that REI demonstrates and the impacts they’ve had on our National Forests and other public lands.”
To celebrate the partnership and National Trails Days, the NFF and REI are collaborating on a volunteer trail restoration event in the San Gabriel Mountains National Monument, outside of Los Angeles. For detailed descriptions of 2017 and 2018 projects supported by REI, please visit www.nationalforests.org/REI.
About the National Forest Foundation
The National Forest Foundation promotes the enhancement and public enjoyment of the 193-million-acre National Forest System. By directly engaging Americans and leveraging private and public funding, the NFF improves forest health and Americans’ outdoor experiences. The NFF’s programs inform millions of Americans about the importance of these treasured landscapes. Each year, the NFF restores fish and wildlife habitat, plants trees in areas affected by fires, insects and disease, improves recreational opportunities, and enables communities to steward their National Forests and Grasslands. Learn more at www.nationalforests.org.
About REI
REI is a specialty outdoor retailer, headquartered near Seattle. The nation’s largest consumer co-op, REI is a growing community of more than 17 million members who expect and love the best quality gear, inspiring expert classes and trips, and outstanding customer service. REI has 152 stores in 36 states. If you can’t visit a store, you can shop at REI.com, REI Outlet or the free REI shopping app. REI isn’t just about gear. You can take the trip of a lifetime with REI Adventures, a global leader in active adventure travel that runs more than 170 custom-designed itineraries worldwide. The REI Outdoor School is run by professionally-trained, expert-instructors who teach beginner- to advanced-level courses about a wide range of activities. To build on the infrastructure that makes life outside possible, REI invests millions annually in hundreds of local and national nonprofits that create access to—and steward—the outdoor places that inspire us all.
¹This year, REI will donate $0.10 per REI Co-op Mastercard purchase transaction made to the National Forest Foundation, up to $1 million. Non-Purchase transactions, including cash advances, convenience checks, balance transfers, and other advance transactions as defined in the Cardmember Agreement, as well as interest charges and fees, do not qualify. Transactions posted in late December of the current year may be applied in the following year. REI may change the benefit or named charity in future years. REI is solely responsible for making the donation.
The creditor and issuer of the REI Co-op Mastercard® is U.S. Bank National Association, pursuant to a license from Mastercard International Incorporated.
© 2018 U.S. Bank
© 2018 Recreational Equipment Incorporated. All rights reserved.
View original content:http://www.prnewswire.com/news-releases/rei-and-national-forest-foundation-team-up-again-in-2018-to-restore-trails-and-connect-youth-to-national-forests-300658479.html
SOURCE National Forest Foundation

Related Links

http://www.natlforests.org

SCOTTSDALE, Ariz. and OTTAWA, Ontario, June 2, 2018 /PRNewswire/ — Natural Partners, Inc. and Fullscript announced plans today to combine, bringing the best wholesale and fulfillment network in the nutritional supplement industry together with the premier online supplement dispensing platform to create a more efficient, effective, and innovative solution for integrative practitioners and patients who seek holistic and natural solutions for wellness.

Supplement protocols are notoriously complicated yet effective when followed; simplifying the patient’s process and routine is critical to improving outcomes. By providing a seamless solution for stocking, prescribing and dispensing, the new merged company gives practitioners the time and resources to create highly personalized wellness plans that are easy for patients to follow.
Natural Partners Fullscript will harness Fullscript’s excellence in software engineering and Natural Partners’ supply chain and merchandising expertise to provide a holistic management solution for integrative practitioners – no matter how they choose to prescribe and dispense. The new company, which will specialize in online dispensary management, speciality distribution, e-commerce, and patient adherence tools, is dedicated to supporting the expanding integrative healthcare market. The company’s new roadmap for service evolution and product innovation is expected to improve health outcomes for patients, while driving increased demand for wellness products and services.
“This combination is unique; we’re bringing together two teams that are completely complementary and laser focused on the future direction of the wellness industry. Fullscript’s strengths are amplified by Natural Partner’s strengths, and vice versa. The Natural Partners team is incredibly passionate, and it takes that kind of passion to make a difference in healthcare. That’s why we were so drawn to the Fullscript team. In an industry that’s fraught with complex issues that have a real impact on human lives, we’ve got something special to contribute – a great strategy, and a team of people that truly care,” said Fran Towey, Chief Executive Officer, Natural Partners Fullscript.
“When my co-founders and I started Fullscript in 2011, we knew we were embarking on a difficult journey with an incredibly worthy mission – we believe in integrative care and we need to make it easier for everyone involved in that industry, especially patients. Every decision we’ve made, every new feature or service that we’ve released in the past five years, it’s all been driven by that mission to take the hassle out of integrative health. The decision to combine with Natural Partners is no exception. They want what we want, they care about the same things we do, and together we can take our services and our platform even further in delivering on that shared goal,” said Kyle Braatz, President, Natural Partners Fullscript.
Natural Partners and Fullscript anticipate completing the transaction in June, assuming satisfaction of customary closing conditions.
About Fullscript:
Fullscript is a fast-growing, health-tech startup with over 2000% GAAP revenue growth in the past three years. Founded in 2011 by Kyle Braatz, Brad Dyment, and Chris Wise, Fullscript was the first online dispensing platform for nutritional supplements, now powering digital dispensing for over 25,000 practitioners, and over 450,000 patients across the U.S. and Canada. Fullscript’s mission is to take the hassle out of integrative healthcare by making supplementation seamless and easy. For more information, visit Fullscript.com.
About Natural Partners:
Natural Partners, Inc. is a resource for integrative healthcare practitioners who strive to improve patient wellness and improve practice economics.  Founded in 1995 by Tye Smith, Natural Partners has researched trusted brands and welcomed them into their portfolio, currently offering over 16,000 premium products from hundreds of high-quality manufacturers.  No matter how integrative practitioners do business, Natural Partners ensures their patients get the products they need, when they need them, in a way they love. For more information, please visit naturalpartners.com.

View original content with multimedia:http://www.prnewswire.com/news-releases/natural-partners-and-fullscript-plan-to-merge-to-create-the-industry-leading-technology-enabled-wellness-management-service-for-integrative-healthcare-practitioners-and-patients-300658666.html
SOURCE Natural Partners, Inc.

Related Links

http://www.naturalpartners.com

LOS ANGELES, June 1, 2018 /PRNewswire-USNewswire/ — Century Housing Corporation was honored for its affordable development work at the 48^th Annual Los Angeles Architectural Awards, hosted by the Los Angeles Business Council (LABC) on June 1st at the Beverly Hilton.  Century received the Housing Award, which recognized Anchor Place and the whole project team for its groundbreaking design and commitment to meeting the modern day needs of Los Angeles. 

Anchor Place, Century’s fifth phase of campus development, provides 120 permanent supportive homes for homeless veterans and homeless families. Located at the foot of River Avenue, the mixed population LEED-certified development expands upon Century’s permanent supportive housing offerings while providing extensive service and amenity space.
The Anchor Place development coupled with the social hall renovation and transit infrastructure improvements to River Avenue creates a hub for activity on campus, aiding access to vital services and job centers while creating a more pedestrian friendly environment.  Together, these developments will provide Century’s Villages at Cabrillo and its 1,500 residents with a built environment that is conducive to the transformation they seek: health & wellness, personal development and restoration of hope.
“This year we received over 275 submissions in 23 design categories, representing a historic number of high quality projects,” said Mary Leslie, President of the Los Angeles Business Council. “Congratulations to this year’s exceptional and diverse winners.”
This year boasted an especially competitive pool of applicants, with 54 winning projects awarded by the LABC. From brick and mortar retail transformed into creative office environments, to mixed use developments and the tallest new building west of the Mississippi, the project winners reflect a city in transition demanding new, innovative ideas from the architectural community.
The keynote address was delivered by Joshua Ramus, Founding Principal of REX and widely regarded as one of the industry’s most promising young architects.
This year’s grand prize was presented by Culver City Mayor Thomas Small to Vespartine, a pioneering new restaurant featuring a world-renowned chef and breathtaking structural design. The eye-catching building, clad with a curving steel and glass façade, creates a unique and memorable dining experience.
A full list of honorees as well as pictures is available at www.labusinesscouncil.org.

View original content:http://www.prnewswire.com/news-releases/century-wins-housing-award-for-affordable-development-at-48th-annual-los-angeles-architectural-awards-300658564.html
SOURCE Century Housing Corporation

Alport Syndrome Pipeline Analysis report covers 5 drugs currently in different phases of development.The report provides Alport Syndrome treatment drugs by company, phases of development including products in early discovery stage and NDA filing, molecule type, route of administration and region. The report will help to evaluate the collaboration, in-licensing and out-licensing opportunities, formulating business development strategies and tracking the activities of the key market players.Epidemiology, major drivers, restraints, and opportunities have been covered to provide an exhaustive picture of the market. The analysis presents in-depth information regarding the development, trends, and industry policies and regulations implemented to offer stakeholders a better understanding of the key factors affecting the overall market environment.Major industry players profiled as part of the report are Ember Therapeutics, Foresee Pharmaceuticals Co., Ltd., Reata Pharmaceuticals, Inc., Regulus Therapeutics Inc. and Variant Pharmaceuticals, Inc.Key Topics Covered:1. Introduction
1.1. Research Methodology
1.2. Research Scope
1.2.1. Analysis by Company
1.2.2. Analysis by Phase
1.2.3. By Molecule Type
1.2.4. By region2. Disease Overview3. Executive Summary4. Market Dynamics
4.1. Drivers
4.2. Restraints
4.3. Opportunities5. Pipeline Analysis/Outlook
5.1. Analysis by Company
5.2. Analysis by Phase
5.2.1. Phase of Development
5.2.1.1. Introduction
5.2.1.1.1. Drug Profiling
5.2.1.1.2. Strategic Developments
5.2.1.1.3. Clinical trials
5.2.1.1.4. Clinical trial results
5.2.1.1.5. Patents
5.2.1.1.6. Technology
5.2.2. Comparative Analysis for Trials by Phase (Pie, Bar graph)
5.3. By Molecule type
5.4. Analysis by Region6. Company profiling

• Ember Therapeutics
• Foresee Pharmaceuticals Co., Ltd.
• Reata Pharmaceuticals, Inc.
• Regulus Therapeutics Inc.
• Variant Pharmaceuticals, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/2hp8zc/alport_syndrome?w=5
Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.comFor E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
View original content:http://www.prnewswire.com/news-releases/alport-syndrome-pipeline-analysis-2018-5-drugs-currently-in-different-phases-of-development-300658060.html
SOURCE Research and Markets

Related Links

http://www.researchandmarkets.com

DALLAS, June 1, 2018 /PRNewswire/ — NexPoint Strategic Opportunities Fund (NYSE: NHF) (“NHF” or the “Fund”) today announced its regular monthly dividend on its common stock of $.20 per share. The dividend will be payable on June 29, 2018 to shareholders of record at the close of business June 22, 2018. 

The Fund is a closed-end fund managed by NexPoint Advisors, L.P. (the “Manager”), an affiliated adviser of Highland Capital Management, L.P. The Fund invests primarily in below investment grade debt, equity securities and real estate and has the ability to hedge risk. The Manager attempts to deliver consistent returns in excess of the Dow Jones Credit Suisse Hedge Fund and the HFRX Global Hedge Fund indices in a transparent, registered fund format consistent with monthly dividends.

Total operating expenses as of the most recent fund annual report are 2.21%. Performance data represents past performance, which does not guarantee future results. Current performance may be higher or lower than the figures shown. Investment return and principal value will fluctuate with market conditions, and you may have a gain or loss when you sell your shares. For most recent month-end performance please visit www.nexpointadvisors.com or call 866-351-4440.
Investors should consider the investment objectives, risks, charges and expenses of the NexPoint Strategic Opportunities Fund carefully before investing. This and other information can be found in the Fund’s prospectus, which may be obtained by calling 1-866-351-4440 or visiting www.nexpointadvisors.com. Please read the prospectus carefully before you invest.
Interest Rate Risk. Interest rate risk is the risk that debt securities, and the Fund’s net assets, may decline in value because of changes in interest rates. Generally, fixed rate debt securities will decrease in value when interest rates rise and increase in value when interest rates decline.
Leverage Risk. The Fund uses leverage through borrowings from notes and a credit facility, and may also use leverage through the issuances of preferred shares. The use of leverage magnifies both the favorable and unfavorable effects of price movements in the investments made by the Fund. Insofar as the Fund employs leverage in its investment operations, the Fund will be subject to substantial risks of loss.
Closed-End Fund Risk. The Fund is a closed-end investment company designed primarily for long-term investors and not as a trading vehicle.  No assurance can be given that a shareholder will be able to sell his or her shares on the NYSE when he or she chooses to do so, and no assurance can be given as to the price at which any such sale may be effected.
Industry Concentration Risk. The Fund must invest at least 25% of the value of its total assets at the time of purchase in securities of issuers conducting their principal business activities in the real estate industry.  The Fund may be subject to greater market fluctuations than a fund that does not concentrate its investments in a particular industry.  Financial, economic, business, and other developments affecting issuers in the real estate industry will have a greater effect on the Fund, and if securities of the real estate industry fall out of favor, the Fund could underperform, or its NAV may be more volatile than, funds that have greater industry diversification. 
Credit Risk. Investments rated below investment grade are commonly referred to as high-yield, high risk or “junk debt.” They are regarded as predominantly speculative with respect to the issuing company’s continuing ability to meet principal and/ or interest payments. Non-payment of scheduled interest and/or principal would result in a reduction of income to the Fund, a reduction in the value of the asset experiencing non-payment and a potential decrease in NAV of the Fund.
Illiquidity of Investments Risk. The investments made by the Fund may be illiquid, and consequently the Fund may not be able to sell such investments at prices that reflect the Investment Adviser’s assessment of their value or the amount originally paid for such investments by the Fund.
About NexPoint Strategic Opportunities Fund
NexPoint Strategic Opportunities Fund (formerly known as NexPoint Credit Strategies Fund) is a closed-end fund managed by NexPoint Advisors, L.P. The Fund’s investment objectives are to provide both current income and capital appreciation. The Fund is invested primarily in below investment grade debt, equity securities and real estate and has the ability to hedge risk. The Fund’s investment adviser attempts to deliver consistent returns in excess of the Dow Jones Credit Suisse Hedge Fund and the HFRX Global Hedge Fund indices in a transparent, registered fund format consistent with monthly dividends. No assurance can be given that the Fund will achieve its investment objectives.
Shares of closed-end investment companies frequently trade at a discount to net asset value. The price of the Fund’s shares is determined by a number of factors, several of which are beyond the control of the Fund. Therefore, the Fund cannot predict whether its shares will trade at, below or above net asset value. Past performance does not guarantee future results.
MEDIA CONTACT:
Lucy Bannon
lbannon@highlandcapital.com
+1 (972) 419-6272

View original content with multimedia:http://www.prnewswire.com/news-releases/nexpoint-strategic-opportunities-fund-announces-the-regular-monthly-dividend-300658548.html
SOURCE NexPoint Advisors, L.P.

UTRECHT, Netherlands, June 1, 2018 /PRNewswire/ — NOBLES MEDICAL TECHNOLOGIES II, INC.  announced today it has officially launched sales in the Netherlands with its first Dutch center performing several successful PFO closure cases at the University Medical Center in Utrecht, Netherlands.   The company is building a growth strategy with this expansion further into the European Market and The Netherlands is a key territory with the continued growth of PFO closures in Holland.   NMT 2 has partnered with one of the top distributors in the region, Angiocare B.V.   Over the past 14 years Angiocare has established itself as a leader in offering new innovative technologies to their customers.  Jan Willem Jongma Angiocare’s Director, like many of our distributors Jan personally sought out NobleStitch™ EL as a device he wanted to add to their profile of products. 

Dr. Pieter R Stella, MD, PhD the Head of Interventional Cardiology at the University Medical Center in Utrecht expressed his views following his initial experience using the NobleStitch™ EL.  “I was positively impressed with the use of the system and the good outcome we experienced in the first patients.” Dr. Stella is continuing to grow his experience with the NobleStitch™ EL and with Dr. Federico De Marco of Italy who was an author and investigator on the Italian clinical study recently published in EuroIntervention, who proctored Dr. Stella’s initial cases and will be joining Dr. Stella for his upcoming NobleStitch™ EL cases. 
Professor Anthony Nobles, CEO and Inventor of the NobleStitch™ EL, noted, “The Netherlands is a natural market for us.  Having one of the best healthcare systems in the world, with a high standard for improving patient treatment and outcomes.   Having the ability with our rapid growth to bring physicians together in proctoring our device is another validation of its success.  The added collaboration supports our belief that with each new user there is an added affirmation of the devices ease of use and success in treatment.  The results we are seeing both at the time of procedure and post procedural are reinforcing all the data we have been collecting over the past years which verifies the safety and efficacy which we believed in from the start. I also am excited to provide regular updates to the patients, physicians and our shareholders on the growth and benefits of the NobleStitch across the world.”
Read the recent data published in EuroIntervention showing the benefits of NobleStitch™ over traditional umbrella occluders, (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html)
About PFO Closure
A PFO is a relatively common heart defect characterized by an unsealed tunnel between the right and left atria of the heart.  This defect has been known to be present in anywhere between 27%-38% of people. However, in a number of cases, it is benign.
The PFO is formed as a trace of the fetal circulation. When the chambers of a human heart begin to develop, a communication is made between the right and left atria, allowing blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning fetal lungs.  Following birth, the pressure differential between the right and left atria changes with newly operational blood flow to the fully functioning lungs.  Because of this, the communication eventually closes completely within the first few months.
However, in some patients, the foramen ovale fails to seal and remains “patent”.  In patients with a Patent Foramen Ovale (PFO), the communication can reopen under elevated atrial pressure, such as coughing, or straining.
A key issue with PFO is that it gives a pathway for blood clots to pass directly to the arterial circulation without being filtered out by the capillary bed of the lungs.  A PFO can also let deoxygenated blood and certain chemicals cross over to the arterial side.  The presence of a PFO has been linked to a number of clinical issues, mainly strokes, migraines and chronic fatigue.  Developments are being made to solidify the link between PFO and strokes or migraines, and to identify patients that would benefit from PFO closure.
About Nobles Medical Technologies II
Nobles Medical Technologies II, Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the PFO, ASD-closure, and cardiovascular-suturing marketplace.  The company does business under the name of Nobles Medical II (NMT 2).  Initial efforts of the company have been focused in Europe on the innovative suture-based PFO closure system for closing the Patent Foramen Ovale (PFO), a tunnel between the right and left atria of the heart.
The NobleStitch™ is approved for PFO Closure and Cardiovascular suturing in the European Union. 
The NobleStitch™ EL is FDA cleared for Vascular and Cardiovascular suturing in the United States.  Further information including warnings and precautions can be found in the instructions for use.
NobleStitch™ EL is distributed worldwide by HeartStitch^®, Inc. (HeartStitch^® is a registered trademark of HeartStitch, Inc.).
NobleStitch™ EL for PFO closure
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.
HeartStitch^® manufactures and markets the NobleStitch™ EL under exclusive license from Nobles Medical Technologies II, Inc.  NobleStitch™ EL is FDA cleared for vascular suturing in the United States and CE Marked for cardiovascular suturing and PFO closure in the European Union and the Republic of Kazakhstan, respectively.
For more on Nobles Medical Technologies II visit http://www.noblesmed2.com.
info@noblesmed2.com

View original content with multimedia:http://www.prnewswire.com/news-releases/noblestitch-el-continues-expansion-through-europe-with-sales-launch-in-the-netherlands-300658554.html
SOURCE Nobles Medical Technologies II, Inc.

Related Links

http://www.noblesmed2.com