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Home › PDUFA Calendar › CAPR

CAPR PDUFA Date: Deramiocel (CAP-1002)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-08-22 · Capricor Therapeutics Inc. · Duchenne Muscular Dystrophy (DMD)
More Rare Disease FDA decisions →All August 2026 PDUFA dates →

The story

Deramiocel (CAP-1002) is under FDA review to treat Duchenne Muscular Dystrophy (DMD). Balance sheet: about 36 months of cash, runway ~36 mo (estimated).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREELNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)MRNA . 2026-08-05Same month decision . mRNA-1010
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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See the full 2026 PDUFA calendar →

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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.