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Home › FDA Decisions › REPL 2025-07-22

REPL FDA Decision CRL · 2025-07-22

Updated ·next FDA decision on the calendar
efficacy CRL: RP1 melanoma BLA CRL: IGNYTE not adequate/well-controlled

Price into the decision (T-120)

PDUFA 7/22/25$14.31$6.922/4/25
Daily close, T-120 (2/4/25) through T+5. Run-up high $14.31 on 2/26/25, low $6.92 on 4/16/25 (T-120 to T-1). FDA decision 7/22/25. Historical price action, not a forecast.

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
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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