UPDATED: Amylyx shares routed on skeptical adcomm docs — but did the FDA leave an open door on unmet ALS need? - Endpoints News


3/28/2022 12:00:00 AM3 years 1 month ago
by Max Gelman

The FDA released its briefing documents for Wednesday’s advisory committee to discuss Amylyx Pharmaceuticals’ ALS drug, and the initial impression appears to bode poorly for the biotech — at least on the data. Agency statisticians called into question the com…

Oncolytic virus biotech Replimune put out a comprehensive pipeline update Wednesday morning, indicating its lead program remains on its development track. But questions lingered regarding a follow-up… [+549 chars]

full article...