Advanced melanoma — progressed on anti-PD-1 therapy (combination with nivolumab)
Key Notes
FDA issued SECOND Complete Response Letter (CRL) on April 10, 2026 — on PDUFA target date. This is Replimune's second CRL for RP1 in advanced melanoma; first CRL was July 2025. BLA was resubmitted as Class 2 resubmission with new April 10, 2026 PDUFA date after Type A meeting. IGNYTE trial data submitted (single-arm, RP1 + nivolumab in anti-PD-1-pretreated advanced melanoma). FDA raised unresolved concerns about reliability of single-arm study design and heterogeneity of patient population in IGNYTE — regulatory thesis that market had rebuilt around a recovery narrative proven wrong. Replimune stock -64% in after-hours trading on April 10. REPL has 1 year to resubmit or withdraw; may request Type A post-action meeting. Company indicated it may consider discontinuing RP1 development if FDA requires new randomized trial vs Opdivo monotherapy. Sub-$300M market cap post-CRL.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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