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Investing.com - Barclays (LON:BARC) has reiterated an Overweight rating and $17.00 price target on Replimune Group (NASDAQ:REPL), representing a significant upside from the current price of $2.93, following a Complete Response Letter (CRL) from the FDA for the company’s RP1 therapy. According to InvestingPro data, the stock has shown strong returns over the past three months despite recent challenges.
The FDA rejected Replimune’s Biologics License Application (BLA) for RP1 in combination with nivolumab for PD1-refractory melanoma patients, citing issues with trial design and insufficient evidence of efficacy. The agency did not raise any safety concerns in its determination. InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt, though it’s currently experiencing rapid cash burn.
The FDA concluded that the IGNYTE trial lacked sufficient control and interpretability due to population heterogeneity, and therefore did not constitute substantial evidence of efficacy. The regulatory body also found the confirmatory trial design inadequate, including unclear contribution of RP1 within the combination therapy.
Replimune plans to request a Type A meeting with the FDA following this setback. The company had previously received Breakthrough Therapy Designation for RP1 and had aligned with the FDA on the confirmatory trial design.
Barclays views this development as a positive for Iovance’s (NASDAQ:IOVA) Amtagvi, which now faces reduced competition in the PD1-refractory melanoma setting, and notes this setback adds to challenges facing the broader oncolytic virus field. For deeper insights into biotech sector dynamics and comprehensive analysis of companies like Replimune, access the full research report on InvestingPro, where you’ll find 8 additional key insights about REPL’s financial health and market position.
In other recent news, Replimune Group has faced a significant setback as the U.S. Food and Drug Administration issued a Complete Response Letter for its Biologics License Application for RP1, a melanoma treatment. The FDA’s decision was based on concerns regarding the IGNYTE trial, which was deemed inadequate and poorly controlled, lacking substantial evidence of effectiveness. This development has sent the company back to the drawing board, as noted by BMO Capital, which nonetheless maintained its Outperform rating with a $27.00 price target for Replimune.
Despite the FDA’s rejection, H.C. Wainwright reiterated its Buy rating with a $22.00 price target, emphasizing the importance of the regulatory decision date. In addition, Cantor Fitzgerald initiated coverage of Replimune with an overweight rating, reflecting ongoing interest from analysts. These recent developments highlight the challenges and ongoing interest in Replimune’s RP1 therapy for advanced melanoma.
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