FDA briefed against Capricor and Replimune ahead of advisory meetings; Capricor lost ~70% value, Replimune ~40% after negative briefing documents released.
Two days, two similar briefing documents and two companies with diving share prices.
The FDA this week laid out its concerns with clinical data from …
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FDA officials say they’ll place renewed emphasis on advisory meetings for contested product applications.
Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more…
FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove…
FDA staff say Capricor's deramiocel fails to show clear efficacy for Duchenne, tanking shares 65%+ ahead of this week's adcomm…
Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation…
Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.…
