Cantor Downgrades Replimune After FDA Rejection

Cantor Fitzgerald downgraded Replimune Group (NASDAQ: REPL) to Neutral from Overweight after FDA issued a complete response letter rejecting RP1‑nivolumab biologics license.
The FDA rejected the biologics license application, citing inadequate and uninterpretable clinical data dating back to 2021 and a July 2025 CRL.
Replimune’s stock fell 30% in a week to $4.76, while the company holds $270 million cash, $283 million annual burn and a 5.6 ratio.
FDA questioned the Phase 3 IGNYTE‑3 design and requested a meeting to discuss a revised RP1‑104 protocol or a new study.