Upcoming FDA decision · November 22, 2026
Deramiocel (CAP-1002) PDUFA date: FDA decision expected November 22, 2026
37 days to goCapricor Therapeutics, Inc. (CAPR) →
The FDA is expected to decide on Deramiocel (CAP-1002) from Capricor Therapeutics, Inc. in Duchenne muscular dystrophy (upper limb function) by the PDUFA target action date of November 22, 2026. For Duchenne muscular dystrophy (upper limb function). BLA; extended from Aug 22 after a major amendment. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: capricor.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 22
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Deramiocel (CAP-1002)?
- The FDA's PDUFA target action date for Deramiocel (CAP-1002) is November 22, 2026. The FDA can act before that date, and the review can be extended.
- What is Deramiocel (CAP-1002) being reviewed for?
- The application under FDA review covers Duchenne muscular dystrophy (upper limb function).
- Which company is developing Deramiocel (CAP-1002)?
- Capricor Therapeutics, Inc. (CAPR).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).