Capricor Therapeutics Says FDA Extends PDUFA Target Action Date For Its BLA For Deramiocel, Investigational Cell Therapy For Duchenne Muscular Dystrophy, From August 22 To November 22
– New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication –SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Capricor
The FDA asked Capricor to send more information about their new medicine for a muscle disease, so the decision date moved from August to November. When a company needs extra time to explain their medicine, it usually means regulators want to be really sure it's safe and works before saying yes.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only — not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.