Replimune's TUDRIQEV wins FDA accelerated approval, launch set within 60 days
Replimune reports fiscal Q1 2027 results alongside the melanoma therapy's approval, a new commercial chief, and a completed $150 million financing.
SEC filing
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Friday, August 14
Monday, August 10
Replimune's $150 million offering formalized in prospectus supplement filed with SEC
Terms match the August 10 pricing announcement, with details on the underwriting agreement and Advisory Committee vote behind TUDRIQEV's approval now on file.
SEC filing (2)
Thursday, August 6
FDA grants accelerated approval to Replimune's TUDRIQEV plus nivolumab for melanoma
The August 6, 2026 approval covers adults with advanced cutaneous melanoma that progressed on prior anti-PD-1 therapy, based on tumor response data from the IGNYTE trial.
SEC filing
Thursday, July 30
FDA advisory committee backs RP1 efficacy data in advanced melanoma, 10-3
The panel found IGNYTE study results evaluable and clinically meaningful ahead of an August 2, 2026 FDA action date for Replimune's BLA resubmission.
SEC filing (2)