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Commercial-stage biotechnology company developing cancer immunotherapies
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In short: Replimune received FDA accelerated approval for TUDRIQEV to treat advanced melanoma and secured $150 million in financing for its launch.
The FDA granted accelerated approval for TUDRIQEV with nivolumab for advanced melanoma. The company expects launch within 60 days, completed a $150 million financing, and appointed a new Chief Commercial Officer.
The offering includes 9,701,490 shares and pre-funded warrants for 2,736,340 shares, with gross proceeds of approximately $150 million before expenses.
The combination with nivolumab is approved for adults with unresectable advanced cutaneous melanoma after progression on an anti-PD-1 regimen, based on objective response rate and duration of response.
The FDA advisory committee voted 10 to 3 that the IGNYTE study's efficacy results are evaluable and clinically meaningful, with an action date of August 2, 2026.
While a positive advisory committee meeting seemed to up the odds of approval for Replimune's twice-snubbed melanoma drug in July, the fate of vusolimogene oderparepvec...
In today's Pharmaceutical Executive Daily, FDA's advisory committee votes in favor of Replimune's...
Replimune Group (REPL) Analyst Rating Update On August 26, 2026, JP Morgan maintained an Overweight...
Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that...
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