Deramiocel (CAP-1002) is a Capricor Therapeutics Inc. program in Duchenne muscular dystrophy; refined proposed indication focused on upper limb function. Its PDUFA date is Nov 22, 2026, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Duchenne muscular dystrophy; refined proposed indication focused on upper limb function. Sponsor: Capricor Therapeutics Inc. (CAPR). Review status: PDUFA target action date extended from August 22, 2026 to November 22, 2026. Capricor submitted a BLA amendment after the July 2026 advisory committee meeting containing 24-month open-label extension data from the pivotal Phase 3 HOPE-3 study and additional robustness analyses, in support of a refined proposed indication focused on upper limb function (the HOPE-3 primary endpoint). CBER accepted it, classified it a major amendment, and added three months to review it. The application remains under review: this is an extension, not a Complete Response Letter. Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
Deramiocel (CAP-1002)'s PDUFA date is Nov 22, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Deramiocel (CAP-1002) is in our archive yet.
In our records Deramiocel (CAP-1002) is under review or in development for Duchenne muscular dystrophy; refined proposed indication focused on upper limb function.
Capricor Therapeutics Inc. (CAPR).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.