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BLA重新提交接受黑色素瘤资产后，Replimune股价飙升108%

2025-10-20 21:00

The US FDA has accepted Replimune's (NASDAQ:REPL) BLA submission of RP1 in combination with Bristol Myers Squibb's (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 of April 10, 2026.
In July, the FDA issued a Complete Response Letter for Replimune, citing 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
Replimune Group: The Prospects For FDA Approval After Rejection
Replimune: A Surprise CRL Exposes Fragility Of The Melanoma Program
Replimune cut to Underweight at J.P. Morgan on further headline risk
Replimune down amid uncertainty over accelerated approval

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