CAPR
Deramiocel (CAP-1002)
FDA PDUFA Target Action Date · Capricor Therapeutics, Inc.
Saturday, August 22, 2026
Decision delayed
delayed Note: PDUFA extended 3 months from 2026-08-22 to 2026-11-22: FDA classified the submission of 24-month HOPE-3 open-label extension data and analyses supporting a refined upper-limb indication as a major amendment. Source: Capricor 8-K 2026-08-24 https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm
Drug Information
- Drug Name
- Deramiocel (CAP-1002) (CT.gov)
- Application Type
- BLA
- FDA Designations
- Orphan DrugPriority Review
- Indication
- Duchenne muscular dystrophy (DMD) cardiomyopathy
- Approved As
- Deramiocel (CAP-1002)
Filing Details
- Company
- Capricor Therapeutics, Inc.
- Stock Ticker
- CAPR
- SEC CIK
- 0001133869
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue