CAPR FDA Decision CRL · 2025-07-11 Updated August 8, 2026 · next FDA decision on the calendar efficacy CRL, Deramiocel DMD BLA CRL: insufficient efficacy + CMC items
Price into the decision (T-120) PDUFA 7/11/25 $15.95 $6.34 1/24/25 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.
Decision facts FDA decision date 2025-07-11
Outcome ✗ CRL ✓ source-verified
Decision-day move -33.0%
T-120 run-up (low→high) +16.0% ($6.34→$14.36)
CRL reason efficacy, Deramiocel DMD BLA CRL: insufficient efficacy + CMC items
Market-cap tier Micro
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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