other material
confidence high
sentiment positive
materiality 1.00
Replimune wins FDA accelerated approval for TUDRIQEV melanoma combo; Q1 net loss $69.8M
Replimune Group, Inc.
- FDA granted accelerated approval for TUDRIQEV (RP1) plus nivolumab in advanced melanoma; launch within 60 days.
- Completed $150M financing; net proceeds $141M; cash and equivalents $195.3M as of June 30, 2026.
- Q1 FY2027 net loss $69.8M vs $86.7M; R&D $49.3M, SG&A $19.0M.
- Michelle DiNapoli appointed Chief Commercial Officer, effective Aug 18, 2026; ex-Deciphera.
- IGNYTE-3 confirmatory trial readout expected 2030; REVEAL Phase 2/3 for RP2 enrolling.