Replimune: Scope Goes Beyond That Of RP1 Oncolytic Targeting For Melanoma
2025-04-28 15:26:21 ET
Summary
- Replimune Group, Inc.'s BLA of RP1 + OPDIVO in advanced melanoma received an FDA Priority Review, with a PDUFA date set for July 22, 2025.
- RP2, adding an anti-CTLA-4 component, is being tested in metastatic uveal melanoma and 2nd-line metastatic hepatocellular carcinoma patients.
- Financially, Replimune has $536.5 million in cash, but REPL will likely need additional funding within the next 12 months.
- The global liver cancer drugs market is expected to reach $14.9 billion by 2031.
The last time I wrote about Replimune Group, Inc. ( REPL ) it was in a Seeking Alpha article entitled " Replimune: RPL1 BLA Submission Under AA Pathway Makes It A Must Watch. " With respect to this particular article, I noted that the company had submitted its Biologics License Application [BLA] of RP1 + OPDIVO [nivolumab] for the treatment of patients with advanced melanoma. I'm happy to state that not only did the FDA accept this BLA submission, but it did so under a Priority Review with a Prescription Drug User Fee Act [PDUFA] date of July 22, 2025. The thing is that this company isn't only relying on the development of RP1 + OPDIVO in the targeting of patients with anti-PD-1 failed melanoma....
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Replimune: Scope Goes Beyond That Of RP1 Oncolytic Targeting For MelanomaNASDAQ: REPL
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