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Investing.com - H.C. Wainwright has reiterated its Buy rating and $22.00 price target on Replimune Group (NASDAQ:REPL), currently trading at $9.40, as the company approaches a key regulatory decision date. According to InvestingPro data, analyst targets range from $16 to $31, with a strong consensus recommendation favoring the stock.
The firm’s analysis focuses on Replimune’s Biologics License Application (BLA) for RP1 in combination with Opdivo (nivolumab), which is under FDA review for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.
The FDA has granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025, meaning a decision is expected by that date.
Replimune has been informed by the FDA that the agency is not currently planning to hold an Advisory Committee meeting regarding this application, and no potential review issues have been identified at this time.
The BLA submission is based on results from the IGNYTE clinical trial, which evaluated the combination of RP1 and Opdivo specifically in melanoma patients who had failed prior anti-PD1 therapy.
In other recent news, Replimune Group reported a significant miss on its first-quarter 2025 earnings, with an earnings per share (EPS) of -$3.07, far below the expected -$0.72. Despite this, the company’s cash and cash equivalents increased to $483.8 million, extending its cash runway into the fourth quarter of 2026. Meanwhile, Piper Sandler analysts raised their price target for Replimune stock to $22, maintaining an Overweight rating, following updates from the company, including additional RP1 data disclosed at the ASCO conference. Analysts from JPMorgan reiterated an Overweight rating with a $16 price target, emphasizing the high probability of timely approval for RP1 in anti-PD1 failed melanoma, with a PDUFA date set for July 22, 2025. Cantor Fitzgerald also initiated coverage of Replimune with an Overweight rating, highlighting the RP1 therapy’s potential for accelerated approval and significant sales by 2030 and 2040. Replimune has been actively preparing for the commercial launch of RP1, with plans to have 150 centers ready for injection upon approval. The company’s commercial strategy includes a team of 60 professionals to support the launch, focusing on academic centers and a broad range of patients.
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