CAPR
Deramiocel (CAP-1002)
FDA PDUFA Target Action Date · Capricor Therapeutics, Inc.
Sunday, November 22, 2026
8 days away
Note: Extended from 2026-08-22 (FDA major amendment: 24-month HOPE-3 open-label extension data + refined upper-limb indication). Capricor 8-K 2026-08-24.
Drug Information
- Drug Name
- Deramiocel (CAP-1002) (CT.gov)
- Application Type
- BLA
- FDA Designations
- Orphan DrugPriority Review
- Indication
- Duchenne muscular dystrophy (DMD); refined proposed indication focused on upper limb function
Filing Details
- Company
- Capricor Therapeutics, Inc.
- Stock Ticker
- CAPR
- SEC CIK
- 0001133869
- Source
- SEC 8-K →
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: 2026-10-06. Report an issue