Replimune says FDA accepts RP1 melanoma BLA resubmission for review

Replimune

Replimune

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  • Replimune’s FDA accepted for review the resubmitted BLA for RP1 with nivolumab in advanced melanoma.
  • Agency classified the filing as a complete class 1 response; target action date set for Aug. 2, 2026.
  • FDA expects to hold an advisory committee meeting in late July.
  • Application seeks accelerated approval based on IGNYTE trial data in patients progressing on anti-PD-1 therapy.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Replimune Group Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606260800PRIMZONEFULLFEED9753142) on June 26, 2026, and is solely responsible for the information contained therein.

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