Replimune soars 108% on BLA resubmission acceptance of melanoma asset

[Percentage Symbol with Slash Transforming into Upward Growth Graph Representing Financial Gains and Market Trends]
J Studios

* The US FDA has accepted Replimune's (NASDAQ:REPL [https://seekingalpha.com/symbol/REPL]) BLA submission of RP1 in combination with Bristol Myers Squibb's (BMY [https://seekingalpha.com/symbol/BMY]) Opdivo (nivolumab) for advanced melanoma.
* Shares are up ~108% in pre-market trading Monday.
* RP1 would be used in patients who have failed on a treatment regimen containing a PD-1 inhibitor.
* The candidate has an FDA action date [https://seekingalpha.com/pr/20271325-replimune-announces-fda-acceptance-of-bla-resubmission-of-rp1-for-the-treatment-of-advanced] of April 10, 2026.
* In July, the FDA issued a Complete Response Letter for Replimune, citing [https://seekingalpha.com/news/4469813-replimune-stock-down-fda-rejects-cancer-drug] inadequacy with the company's IGNYTE trial. Shares tumbled in response.

MORE ON REPLIMUNE GROUP

* Replimune: Further Uncertainty Of RP1 Warrants Move To 'Hold' Rating [https://seekingalpha.com/article/4824547-replimune-further-uncertainty-of-rp1-warrants-move-to-hold-rating]
* Replimune Group: The Prospects For FDA Approval After Rejection [https://seekingalpha.com/article/4810281-replimune-group-the-prospects-for-fda-approval-after-rejection]
* Replimune: A Surprise CRL Exposes Fragility Of The Melanoma Program [https://seekingalpha.com/article/4803149-replimune-a-surprise-crl-exposes-fragility-of-the-melanoma-program]
* Replimune cut to Underweight at J.P. Morgan on further headline risk [https://seekingalpha.com/news/4496636-replimune-stock-downgraded-jp-morgan]
* Replimune down amid uncertainty over accelerated approval [https://seekingalpha.com/news/4496122-replimune-provides-update-on-fda-meeting]