News Issue · Rank #8
FDA sets AdCom and Aug 22 PDUFA for Capricor DMD drug
The FDA scheduled an advisory committee meeting for Capricor's Duchenne therapy deramiocel and confirmed a PDUFA target action date of August 22. Shares fell ~13% as investors de-risked ahead of a binary panel review that will shape the BLA outcome.
Key points to watch
- AdCom panel scheduled for deramiocel (DMD)
- PDUFA target action date: August 22
- Stock down ~13% into the event
- Watch briefing docs and panel vote
– Neutral Rare-Disease Biotech (Neutral)
What's the impact??
Rare-Disease Biotech
NeutralA binary FDA panel and PDUFA date make Capricor an event-driven name with read-through to Duchenne peers.
Coverage
6 sources reporting on this issue
FDA schedules advisory meeting for Capricor’s DMD therapyInvesting.com
- Capricor Therapeutics Faces Stock Drop Ahead of FDA Advisory MeetingIntellectia AI
- Capricor Therapeutics Says Deramiocel BLA PDUFA Target Action Date Set For August 22TradingView
- Capricor faces FDA AdCom panel for Duchenne drug (CAPR:NASDAQ)Seeking Alpha
- Capricor Therapeutics Announces FDA Advisory CommitteeGlobeNewswire
- FDA panel to review Capricor’s Duchenne drug on July 29Stock Titan
AI-estimated from multi-source news and live quotes. Sector impact is a model estimate, not a recommendation. For information only — not investment advice.