pdufa.bio
HomePDUFA Calendar › CAPR

CAPR PDUFA Date: Deramiocel (CAP-1002)

FDA decision (PDUFA) target 2026-08-22 · Capricor Therapeutics Inc. · Duchenne Muscular Dystrophy (DMD)

CAPR run-up into the PDUFA (last ~120 days)

$35.34$25.04
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-22
Drug / candidateDeramiocel (CAP-1002)
IndicationDuchenne Muscular Dystrophy (DMD)
CompanyCapricor Therapeutics Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT05126758 · active

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

FAQ

When is the CAPR PDUFA date?
The FDA PDUFA target date for CAPR (Capricor Therapeutics Inc.) is 2026-08-22 for Deramiocel (CAP-1002). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is CAPR's drug Deramiocel (CAP-1002)?
Deramiocel (CAP-1002) is Capricor Therapeutics Inc.'s candidate under FDA review for Duchenne Muscular Dystrophy (DMD).
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.