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WOBURN, Mass. - The U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for Replimune Group Inc.’s (NASDAQ:REPL) Biologics License Application for its melanoma treatment, the company announced Tuesday. The clinical-stage biotechnology company, currently valued at approximately $950 million, has seen its stock maintain resilience despite the setback, according to InvestingPro data.
The FDA stated it cannot approve the application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma treatment in its current form, citing concerns about the IGNYTE trial. Regulators determined the trial does not provide "substantial evidence of effectiveness" and "cannot be adequately interpreted due to the heterogeneity of the patient population."
The agency also raised concerns about the confirmatory trial study design, including contribution of components. No safety issues were identified in the CRL.
Replimune plans to request a Type A meeting with the FDA, which it expects will be granted within 30 days, to discuss a path forward for potential accelerated approval.
"We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options," said Sushil Patel, Replimune’s Chief Executive Officer, in the press release statement. Patel noted that the issues highlighted in the CRL were not raised during mid- and late-cycle reviews.
RP1 is Replimune’s lead product candidate based on a proprietary strain of herpes simplex virus engineered with a fusogenic protein and GM-CSF, designed to maximize tumor killing and activate systemic anti-tumor immune response.
Replimune, a clinical stage biotechnology company focused on developing oncolytic immunotherapies, is headquartered in Woburn, Massachusetts.
In other recent news, Replimune Group reported its first-quarter earnings for 2025, revealing a significant shortfall in expected earnings per share (EPS). The company posted an EPS of -$3.07, which was well below the forecasted -$0.72. Despite this earnings miss, Replimune’s cash and cash equivalents increased to $483.8 million, extending its cash runway into the fourth quarter of 2026. Piper Sandler analysts responded to recent company updates by raising their price target for Replimune stock to $22 from $14, maintaining an Overweight rating. H.C. Wainwright also reiterated its Buy rating with a $22 price target, focusing on the company’s Biologics License Application for RP1 in combination with Opdivo, currently under FDA review. Cantor Fitzgerald initiated coverage of Replimune with an Overweight rating, ahead of the July 22 PDUFA date for RP1 therapy in advanced melanoma. JPMorgan reaffirmed its Overweight rating and a $16 price target, highlighting the anticipated approval of RP1 for anti-PD1 failed melanoma. Replimune has reported no red flags in its communication with the FDA and is preparing to have 150 centers ready for injection upon RP1 approval.
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