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Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Category CAPR
Capricor Therapeutics Inc
Capricor Therapeutics Inc ( $CAPR ) FDA PDUFA Approval Target (August 22, 2026)
On March 10, 2026, Capricor Therapeutics announced that the FDA has lifted its Complete Response Letter (CRL) and resumed review of the Biologics License Application (BLA) for Deramiocel. The agency assigned a new PDUFA target action date of August 22, 2026—a pivotal moment after months of regulatory uncertainty.
CAPR Capricor Therapeutics Update feb08
FDA asks for the full HOPE-3 clinical study report but does not require new trials, while Capricor prepares a February BLA update. The stock hovers around 23–24 $, with a market cap near 1.16 B$, after a 2025 rally fuelled by Duchenne data and aggressive retail positioning.
CAPR Capricor Therapeutics (CAPR)
Positive Phase 3 HOPE-3 topline results in Duchenne muscular dystrophy cardiomyopathy with statistically significant skeletal and cardiac benefit, reopening the regulatory path after the 2025 CRL.
CAPR Capricor
Capricor Therapeutics [finance:Capricor Therapeutics, Inc.] is a clinical‑stage biotech focused on cell and exosome‑based therapeutics for rare diseases, with lead asset Deramiocel (CAP‑1002) targeting cardiomyopathy in Duchenne muscular dystrophy