efficacy CRL: RP1 melanoma BLA CRL: IGNYTE not adequate/well-controlled
Price into the decision (T-120)
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.
Positioning before the decision
On Jul 8, 2025, 14 days before the decision date, at-the-money options priced a move of ±47.0% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 179%). The stock closed -77.2% at the first close across the decision and -74.3% 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 date2025-07-22
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
Not in this review cycle. On July 22, 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 REPL stock react to the FDA decision?
On the decision day REPL moved -77.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.