Biotech Stock Roundup: EDGE Falls, ALKS Down, FDA OK's AMGN Drug Label Expansion
Zacks Investment Research | Apr 03, 2018 10:56PM ET
It was a week that saw Edge Therapeutics crashing on news of discontinuation of its phase III study, Amgen’s Blincyto getting FDA’s nod for label expansion, EMA accepting Regeneron & Sanofi’s application for label expansion of Dupixent.
Recap of the Past Week’s Most Important Stories
Edge Therapeutics Plummets on Failure of Late-Stage Study: Edge Therapeutics, Inc. (NASDAQ:EDGE) lost almost 92% after the company announced disappointing results from a phase III study, NEWTON 2 on lead pipeline candidate, EG-1962 for the treatment of adults with aneurysmal subarachnoid hemorrhage (aSAH). NEWTON 2 study compared the efficacy and safety of EG-1962 (nimodipine microparticles) to standard of care oral nimodipine in adult patients with aSAH. A pre-specified interim analysis performed on data from the day 90 visit of the first 210 subjects randomized and treated in the study demonstrated a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint if the study is fully enrolled. The independent Data Monitoring Committee (“DMC”) recommended that the study be stopped based on its conclusion that it has a low probability of meeting its primary endpoint. Consequently, Edge Therapeutics has decided to discontinue the NEWTON 2 study. Moreover, the company will reduce the size of its workforce, in order to preserve cash resources, which were $88.1 million as of Dec 31, 2017 due to the failure of the late-stage study. It was the company’s lead candidate and the failure of the study puts a question on its prospects. (Read more: .
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