Capricor Therapeutics: FDA extends Deramiocel PDUFA date to November 22, 2026
Capricor Therapeutics said the FDA extended the PDUFA target action date for the Deramiocel Biologics License Application from August 22, 2026 to November 22, 2026, after classifying the company's amendment as a major amendment. The amendment adds 24-month open-label extension data from the Phase 3 HOPE-3 study and seeks review for a refined indication focused on upper limb function, which delays the timing of a possible FDA decision on the therapy.
Key points
- PDUFA target action date moved from August 22, 2026 to November 22, 2026, a three-month extension
- FDA classified the submission as a major amendment and accepted it for review through CBER
- Amendment includes 24-month open-label extension data from the HOPE-3 study and a request to review a refined indication focused on upper limb function
- CEO Linda Marbán said HOPE-3 met its primary endpoint, a statistically significant benefit in upper limb function
The filing
Written by AI on Nov 9, 2026, 8:36 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on August 24, 2026.
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