Shares of Bristol-Myers Squibb Co (NYSE:BMY) ended Thursday session in green amid volatile trading. The shares closed up +0.48 points or 0.87% at $55.56 with 9.94 million shares getting traded. Post opening the session at $55.35, the shares hit an intraday low of $55.16 and an intraday high of $556.28 and the price vacillated in this range throughout the day. The company has a market cap of $91.96 billion and the numbers of outstanding shares have been calculated to be 1.66 billion shares.
Bristol-Myers Squibb Co (BMY) on September 20, 2016 announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“The high frequency of metastatic urothelial carcinoma and its relapsing nature highlight the substantial need for new treatment approaches with high and durable responses,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “We look forward to working with the EMA to potentially extend the use of Opdivo and bring the science of Immuno-Oncology to help patients in Europe fight this difficult-to-treat, advanced form of bladder cancer.”
The application primarily included data from CheckMate -275, a Phase 2, open-label, single-arm study assessing the safety and efficacy of Opdivo in patients with locally advanced unresectable or mUC that has progressed after a platinum-containing therapy. The primary endpoint in CheckMate -275 trial is objective response rate, and additional efficacy measures included durability of response and overall survival. Data from this study will be presented at the 2016 European Society for Medical Oncology Congress.
Shares of Aralez Pharmaceuticals Inc (NASDAQ:ARLZ) ended Thursday session in red amid volatile trading. The shares closed down -0.18 points or -3.29% at $5.29 with 1.23 million shares getting traded. Post opening the session at $5.45, the shares hit an intraday low of $5.26 and an intraday high of $5.51 and the price vacillated in this range throughout the day. The company has a market cap of $356.87 million and the numbers of outstanding shares have been calculated to be 1.00 shares.
Aralez Pharmaceuticals Inc (ARLZ) on Sept. 15, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved once-daily YOSPRALA™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S. YOSPRALA is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The Company is expanding its U.S. sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the U.S. promotional launch of YOSPRALA the first week in October.
“Daily aspirin is a standard of care for secondary cardiovascular event prevention, but gastrointestinal symptoms are often cited as the reason patients stop taking this important therapy. Discontinuation of daily aspirin therapy for secondary prevention can pose a significant cardiovascular risk,” said Lori Mosca , M.D., M.P.H, Ph.D., a national expert in cardiovascular disease prevention and education. “Published research shows that patients who have or are at risk of coronary artery disease and discontinue daily aspirin treatment have a three-fold higher risk of a major adverse cardiac event, including death, shortly after stopping therapy. Another study documented that aspirin discontinuation following a gastrointestinal bleed in patients with CV disease increases the risk of a cardiovascular event or death almost 7-fold.”