Why Capricor Therapeutics (CAPR) Stock Is Down 70% Today
TLDR
- Capricor Therapeutics stock fell as much as 70% after FDA staff raised concerns about its cell therapy deramiocel
- The FDA flagged that Capricor changed how it measured results after its late-stage trial ended
- Reviewers questioned whether trial patients actually had DMD-related cardiomyopathy
- The FDA also said there was limited evidence the therapy reached the heart in sufficient amounts
- An external advisory committee meeting is scheduled for Wednesday, July 29
Capricor Therapeutics (CAPR) stock cratered as much as 70% on Monday after the FDA released briefing documents ahead of the company’s July 29 advisory committee meeting.
Capricor Therapeutics, Inc., CAPR
The FDA staff documents raised concerns about the effectiveness data for deramiocel, Capricor’s cell therapy targeting cardiomyopathy in male patients with Duchenne muscular dystrophy (DMD).
The stock had already fallen around 40% in early trading before extending losses further through the session.
The Cellular, Tissue, and Gene Therapies Advisory Committee will meet Wednesday to decide whether results from the pivotal HOPE-3 study provide substantial evidence that deramiocel works.
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