Shares of Capricor Therapeutics Inc. (NASDAQ:CAPR) dropped more than 60% Monday after the FDA posted briefing documents ahead of the company’s July 29 advisory committee meeting.
The documents raised doubts about whether the data for the company’s Duchenne cell therapy meets the FDA’s standard for substantial evidence of effectiveness.
- Capricor Therapeutics stock is showing notable weakness. What’s behind CAPR decline?
What the FDA Briefing Documents Reveal
The committee will consider whether results from the pivotal HOPE-3 study provide substantial evidence of effectiveness for the proposed indication, and the FDA’s documents outlined the regulatory standard for approval, generally requiring at least two adequate and well-controlled studies.
Deramiocel’s application rests on a single pivotal Phase 3 trial, so the FDA’s framing signals the agency may view the data package as falling short of its usual bar.
CAPR Shares Plunge Monday Morning
CAPR Price Action: Capricor Therapeutics shares were down 69.09% at $6.09 during premarket trading on Monday, according to Benzinga Pro data.
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