Biotech Stock Roundup: AMGN's Evenity Earns FDA Approval, Deal Wins & More
Zacks Investment Research | Apr 09, 2019 09:20PM ET
The past week was busy for the biotech sector with pipeline updates for most biotech bigwigs. While Amgen (NASDAQ:AMGN) received an FDA nod for its osteoporosis drug, Gilead Sciences, Inc. (NASDAQ:GILD) has submitted an application for the label expansion of its HIV drug, Descovy. Celgene Corporation (NASDAQ:CELG) too has filed a Biologics License Application (BLA) for its pipeline candidate, luspatercept, to the FDA. Meanwhile, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) has extended its collaboration agreement with Alnylam.
Recap of the Week’s Top Stories:
FDA Approves Amgen’s Osteoporosis Drug Evenity: Amgen and partner UCB announced that the FDA has approved osteoporosis drug, Evenity, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The FDA approval was based on the results of two phase III studies, namely FRAME and ARCH. Treatment with Evenity led to a significant reduction of new vertebral (spine) fracture at 12 months compared with placebo as results from the FRAME study demonstrate. Data from the ARCH study showed that treatment with EVENITY for a 12-month regime followed by 12 months of alendronate, significantly reduced the incidence of new vertebral fracture at 24 months. However, the label comes with a boxed warning of increase in the risk of myocardial infarction (heart attack), stroke and cardiovascular death.
Amgen currently carries a Zacks Rank #3 (Hold). You can see RNA interference (RNAi) therapeutics for a broad range of indications by addressing the disease targets expressed in the eye and the central nervous system (CNS) in addition to a select number of targets expressed in the liver.
Moreover, Alnylam is eligible to receive up to an additional $200 million as milestone fees. Regeneron will provide Alnylam with $2.5 million in funding at the initiation of any program and an additional $2.5 million for identifying the lead candidate. Alnylam will also get an extra $30 million in annual discovery funding.
United Therapeutics Plunges on Study Failure: Shares of United Therapeutics Corporation (NASDAQ:UTHR) declined after the company announced that a late-stage study on its pipeline candidate, esuberaprost, did not meet its primary endpoint. The BEAT study was evaluating the pipeline candidate, esuberaprost, in combination with the marketed pulmonary arterial hypertension (PAH) drug, Tyvaso as Tysuberprost, in patients with PAH, who showed signs of deterioration with Tyvaso or had a less than optimal response to the Tyvaso treatment. The primary endpoint of the delayed time to the first clinical worsening event was not successfully met in the study.
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