CAPR FDA Decision CRL · 2025-07-11
efficacy CRL — Deramiocel DMD BLA CRL — insufficient efficacy + CMC items
Price into the decision (T-120)
Historical price action; green = local high, red = low/sell-off.
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
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