Capricor Therapeutics BLA Under FDA Review Following Positive HOPE-3 OLE Data
Capricor Therapeutics announced positive data from its HOPE-3 OLE study, demonstrating a 76% slowing of upper limb decline after crossover to Deramiocel. The company has submitted this data as a major amendment to its Biologics License Application (BLA), which has a PDUFA target action date of November 22, 2026.
Capricor Therapeutics said HOPE-3 OLE data showed a 76% slowing of upper limb decline after crossover to Deramiocel and that the data were included in a major amendment to its BLA. The company said the BLA is now under FDA review, and the PDUFA target action date is Nov. 22, 2026.