FDA pushes back Capricor's Deramiocel PDUFA date to November 22, 2026
The agency classified new HOPE-3 extension data as a major amendment, adding three months to its review of the Duchenne muscular dystrophy therapy.
SEC filing
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Monday, August 24
Thursday, August 13
Capricor gives update on Deramiocel BLA after adcomm setback, reports Q2 2026 results
Capricor said it continues to work with FDA on the Deramiocel BLA following a negative advisory committee vote, as HOPE-3 data appear in The Lancet and cash falls to $238 million.
SEC filing
Thursday, July 30
FDA advisory panel votes against Deramiocel for DMD cardiomyopathy, 9 to 3
Capricor's Deramiocel fell short in a non-binding FDA advisory committee vote, though the panel's PUL 2.0 discussion was more favorable, with a PDUFA date set for August 22, 2026.
SEC filing
Wednesday, July 29
Lancet publishes Capricor's HOPE-3 data as FDA review continues
The peer-reviewed publication comes with a revised LVEF statistical result and disclosure of an FDA inspection finding tied to the Deramiocel trial.
SEC filing
Tuesday, July 14
Capricor discloses San Diego HQ lease tied to Deramiocel FDA decision
The company signed a lease for a new headquarters with rent terms and a termination clause linked to FDA approval by December 31, 2026.
SEC filing