As of Oct 26, 2026: Capricor Therapeutics (CAPR) has a PDUFA date for deramiocel on Nov 22, 2026, in 27 days. Its Quality Score is -7. Scores as of 8:36 PM ET, 15 minutes behind.

CAPR FDA decision on Deramiocel

Capricor Therapeutics · PDUFA date

PDUFA dateNov 22in 27 days Quality Score-7Poor

Cash runway–into Q4 2027

What the company said

“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”

PDUFA date, Nov 22, 2026. As Capricor Therapeutics stated in its 8-K of Aug 24, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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