REPL FDA Decision CRL · 2025-07-22
efficacy CRL — RP1 melanoma BLA CRL — IGNYTE not adequate/well-controlled
Price into the decision (T-120)
Historical price action; green = local high, red = low/sell-off.
Decision facts
FDA decision date2025-07-22
Outcome✗ CRL✓ source-verified
Decision-day move-77.2%
T-120 run-up (low→high)+9.0% ($2.81→$12.63)
CRL reasonefficacy — RP1 melanoma BLA CRL — IGNYTE not adequate/well-controlled
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