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CAPR FDA Decision CRL · 2025-07-11

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
The FDA's own letter · Complete Response Letter, BL 125842 (PDF), dated July 11, 2025, released under FDA's CRL transparency program.
efficacy CRL, Deramiocel DMD BLA CRL: insufficient efficacy + CMC items

Price into the decision (T-120)

PDUFA 7/11/25$15.95$6.341/24/25
Daily close, T-120 (1/24/25) through T+5. Run-up high $15.95 on 2/21/25, low $6.34 on 5/14/25 (T-120 to T-1). FDA decision 7/11/25. Historical price action, not a forecast.
Positioning before the decision
On Jun 27, 2025, 14 days before the decision date, at-the-money options priced a move of ±24.2% through Jul 18, 2025 (the first listed expiry after the decision; ATM implied volatility 128%). The stock closed -33.0% at the first close across the decision and -37.2% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-07-11
Outcome✗ CRL✓ source-verified
Decision-day move-33.0%
T-120 run-up (low→high)+16.0% ($6.34→$14.36)
CRL reasonefficacy, Deramiocel DMD BLA CRL: insufficient efficacy + CMC items
Primary sourceView filing ↗
Market-cap tierMicro
Cohort decision-day move (history)4.7% median (n=312)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding CAPR, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
RA Capital Management1,507,844$36.3 millionfiled August 14, 2026
RTW Investments250,000$6.0 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was source-verified approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on July 11, 2025. A CRL is not final; the primary source is linked on this page.

How did CAPR stock react to the FDA decision?

On the decision day CAPR moved -33.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.