Capricor Therapeutics Gains on Positive DMD Trial Data and FDA Target Date

Key Facts

1HOPE-3 open-label extension data showed Deramiocel slowed upper limb function decline by 76% compared to the patients' prior year.

2Data was included in the BLA major amendment with a PDUFA target action date set for November 22, 2026.

Capricor Therapeutics announced positive data from its HOPE-3 open-label extension study for Deramiocel, a treatment for Duchenne muscular dystrophy (DMD). GlobeNewswire reported that the therapy slowed the decline of upper limb function by 76% compared to the patients' prior year, with the findings included in a major amendment to the company's Biologics License Application (BLA).

The FDA has set a PDUFA target action date of November 22, 2026, to reach a decision on the treatment's approval. In recent market activity, CAPR closed at $8.95 on October 2, 2026, having traded between a session high of $9.24 and a low of $8.77.