Alkermes Plc ALKS shares were trading down Friday as the Street weighed reports of regulatory setbacks for the biopharma.
What Happened
The Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly recommended not to approve Alkermes’ ALKS 5461.
Their review of the candidate found two of the studies to be statistically insignificant — a finding at odds with the conclusions drawn by Alkermes. Ultimately, they ruled the risk-benefit profile of the treatment for major depressive disorder unfavorable.
Why It’s Important
The committees’ recommendation does not guarantee rejection, according to STAT News. Alkermes remains hopeful that the FDA at large will reach a more favorable conclusion.
"We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission,” Alkermes CEO Richard Pops said in a press release.
The company reiterated in its announcement that ALKS 5461’s clinical program revealed consistent antidepressant activity, as well as safety and tolerability.
What’s Next
The FDA will announce its ruling by the drug’s Prescription Drug User Fee Act date on Jan. 31, 2019.
Related Links:
Alkermes Falls 20% After FDA Refusal To File Letter
Analyst: Opioid Legislation Likely Stalled In Senate Until After November Elections
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.