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Investing.com - Replimune Group (NASDAQ:REPL) stock fell to $3.04 after the company received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for RP1 in combination with nivolumab for anti-PD-1-failed melanoma. According to InvestingPro data, the $233.57M market cap company has shown strong returns in recent months despite regulatory challenges.
The FDA indicated that the Phase II IGNYTE trial was not considered "adequate and well-controlled to provide substantial evidence of effectiveness," according to Leerink Partners, which reiterated an Outperform rating and $17.00 price target on the stock. InvestingPro data shows analyst targets ranging from $17 to $31, with 8 more exclusive insights available to subscribers.
Regulators also stated that the trial results "could not be adequately interpreted due to the heterogeneity of the patient population," despite previously positive data from the registrational cohort of the study.
The CRL further noted issues related to the ongoing confirmatory IGNYTE-3 study that need addressing, including contribution of components, marking a setback for the company’s melanoma treatment program.
Replimune plans to request a Type A meeting with the FDA and expects this request to be granted within 30 days as it seeks to address the regulatory concerns.
In other recent news, Replimune Group faced a significant setback as the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its Biologics License Application for RP1, a therapy intended for PD-1 refractory melanoma patients. This decision was based on concerns regarding the adequacy and control of the IGNYTE trial, which showed a 33% objective response rate and a 33.7-month duration of response. Following this development, Wedbush downgraded Replimune’s stock from Outperform to Neutral and significantly reduced its price target from $19.00 to $4.00. Similarly, Cantor Fitzgerald downgraded the stock from Overweight to Neutral. Despite the FDA’s rejection, Barclays (LON:BARC) maintained an Overweight rating with a $17.00 price target, noting no safety concerns but emphasizing trial design issues. BMO Capital also reiterated an Outperform rating and a $27.00 price target, acknowledging the need for Replimune to reassess its trial strategies. These recent developments indicate a challenging period for Replimune as it navigates regulatory hurdles.
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