As previously reported, Wedbush upgraded Replimune (REPL) to Outperform from Neutral with a price target of $18, up from $4. The firm notes the company announced FDA acceptance of BLA submission for RP1 plus nivolumab in advanced melanoma, with a PDUFA date for April 10, 2026, based on an FDA Class II resubmission timeline. The submission is considered to be a complete response to the CRL that Replimune received in July this year. Wedbush views the FDA turnaround following a Type A meeting with Replimune as highly promising. The firm says it has to assume that the FDA has given somewhat of a green light for the re-submission, which includes additional information.
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