Capricor上涨，FDA延长Deramiocel行动日期

2026-08-24 22:27

Capricor Therapeutics (CAPR) is up ~7% in Monday morning trading after announcing that the FDA has extended the action date for its BLA on Duchenne muscular dystrophy therapy Deramiocel by three months to Nov. 22.
The company said that after an agency advisory committee last month, it submitted open-label extension data from the phase 3 HOPE-3 study and additional analyses. Capricor also asked that the proposed indication focus on upper limb function.
The Cellular, Tissue, and Gene Therapies Advisory Committee voted 9-3 that there was not strong evidence that Deramiocel was effective for treating cardiomyopathy in Duchenne.
"In a progressive disease where function, once lost, cannot be recovered, we believe preservation of upper limb function has the potential to translate into meaningful differences in patients' independence and daily lives," Capricor CEO Linda Marbán said in a statement.

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