Shares of Aralez Pharmaceuticals Inc (NASDAQ:ARLZ) ended Monday session in red amid volatile trading. The shares closed down -0.11 points or -2.08% at $5.18 with 1.92 million shares getting traded. Post opening the session at $5.28, the shares hit an intraday low of $4.86 and an intraday high of $5.29 and the price vacillated in this range throughout the day. The company has a market cap of $345.13 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.”
Shares of Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) ended Monday session in green amid volatile trading. The shares closed up +0.13 points or 0.14% at $91.82 with 1.94 million shares getting traded. Post opening the session at $91.99, the shares hit an intraday low of $89.08 and an intraday high of $92.71 and the price vacillated in this range throughout the day. The company has a market cap of $22.86 billion and the numbers of outstanding shares have been calculated to be 247.78 million shares.
Vertex Pharmaceuticals Incorporated (VRTX) on August 16, 2016 provided an update on its ongoing Phase 3 development program of its investigational compound VX-661 in combination with ivacaftor, which includes four studies that together are expected to enroll more than 1,000 people with cystic fibrosis (CF). Based on a planned interim futility analysis conducted by the study’s independent Data Safety Monitoring Board (DSMB), Vertex plans to stop the study of VX-661 and ivacaftor in people with one copy of the F508del mutation and one copy of a mutation that results in minimal CFTR protein function (F508del het/min). There were no safety concerns noted in the DSMB’s review of the data. Vertex also announced that enrollment is now complete in the study of VX-661 and ivacaftor in people with two copies of the F508del mutation (F508del homozygous) and that the company expects to complete enrollment in the study of people with one copy of the F508del mutation and one copy of a residual function mutation in September.
“While we recognize that people with CF with minimal function mutations have a form of the disease that is particularly difficult to treat, we believed it was important to evaluate whether a dual combination of VX-661 and ivacaftor could provide some benefit to these patients given they do not have a medicine to treat the cause of their disease,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex. “These results suggest that a triple combination regimen may provide this group of people with CF the best chance at obtaining a meaningful benefit and we look forward to beginning the first study of a next-generation corrector together with VX-661 and ivacaftor in this group of patients later this year, pending data from our ongoing Phase 1 studies in healthy volunteers.”