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CAPR FDA Decision CRL · 2025-07-11

Updated ·next FDA decision on the calendar
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)4.6% median (n=308)

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

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Questions

Was source-verified approved by the FDA?

Not in this review cycle. On July 11, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. 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.