Capricor Therapeutics Stock Plunges 30% After FDA Rejects Duchenne Therapy BLA

(RTTNews) - Capricor Therapeutics, Inc. (CAPR) shares sank 30 percent to $7.98 on Friday after the company announced it received a Complete Response Letter from the U.S. FDA for its Biologics License Application for Deramiocel, a cell therapy candidate targeting cardiomyopathy in Duchenne muscular dystrophy patients.

The stock opened at $6.99 and ranged between $6.74 and $8.68 on heavy volume of nearly 17 million shares, far exceeding its average volume of 2.6 million on the Nasdaq. CAPR now trades well below its 52-week high of $23.40, hovering closer to its low of $3.52.

The FDA cited a lack of substantial evidence of effectiveness and outstanding manufacturing-related issues, though Capricor says many had already been addressed. Capricor plans to submit data from its ongoing Phase 3 HOPE-3 trial later this year to address the FDA's concerns.