Today, Capricor Therapeutics formally announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s amendment to the Biologics License Application (BLA) for Deramiocel, and the FDA will be extending the current Prescription Drug User Fee Act (PDUFA) action date of August 22, 2026. The FDA has classified the amendment as a major amendment, extending the current action date 90 days to November 22, 2026.

Capricor has confirmed that the BLA amendment includes the 24-month Open Label Extension (OLE) data from the HOPE-3 trial and additional robustness analysis, focused on the HOPE-3 trials primary endpoint of upper limb function. The additional analyses represent a narrowing of the indication to upper limb dysfunction only.

PPMD appreciates Capricor’s continued engagement with the FDA, as well as the FDA’s willingness to accept additional information and analysis for consideration as part of its review.

PPMD has invited Capricor to join us for a community webinar to share information on the updated data they have submitted to the community. Please stay tuned for more information, including date and registration link, to be shared soon.

Review PPMD’s previous updates on Deramiocel here.