FDA briefing documents question Capricor's deramiocel efficacy in DMD, while the company defends its trial analysis ahead of July 29.
Capricor stock falls 61% as FDA challenges Deramiocel efficacy; Phase 3 DMD trial missed primary endpoint, cardiac data show no benefit. Signal for biotech acquirers: late-stage efficacy gaps elevate regulatory risk, erode valuations, tighten clinical M&A discipline.
Capricor Therapeutics Inc.
(NASDAQ:CAPR) stock is trading lower on Monday.
The company provided an update ahead of the company's upcoming FDA Advisory Committee meeting for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
The date for the Advisory Committee meeting is July 29. • Capricor Therapeutics stock is among today's weakest performers.
What's behind CAPR decline?
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