Capricor Therapeutics Stock Gains Over New PDUFA Date For Deramiocel BLA

(RTTNews) - Capricor Therapeutics, Inc. (CAPR), Tuesday announced that the U.S. Food and Drug Administration has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application seeking full approval of Deramiocel for the treatment of Duchenne muscular dystrophy cardiomyopathy.

As per the announcement, the submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act target action date of August 22, 2026.

This comes as the company submitted data and supporting documentation from the HOPE-3 clinical trial, which demonstrated positive results, including achievement of the primary endpoint and all Type I error-controlled secondary endpoints. Notably, this time the FDA has not identified any potential review issues in its response to the company.

Moreover, the company expects to be eligible to receive a Priority Review Voucher upon potential approval of Deramiocel.

Currently, CAPR is moving up 16.00 percent, to $35.53 on the Nasdaq.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.