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Investing.com -- Replimune Group Inc (NASDAQ:REPL) stock plummeted 41.7% Thursday after the clinical-stage biotechnology company failed to secure a clear regulatory pathway for its melanoma treatment following a meeting with the FDA.
The company announced it had completed a Type A meeting with the U.S. Food and Drug Administration on September 16 to discuss the complete response letter for its Biologics License Application. The application sought approval for RP1 in combination with nivolumab for treating advanced melanoma. However, Replimune revealed that "a path forward under the accelerated approval pathway has not been determined" following the meeting.
Replimune is now evaluating the FDA’s feedback to determine next steps for RP1, its lead product candidate. The therapy is based on a proprietary strain of herpes simplex virus engineered with a fusogenic protein and GM-CSF, designed to maximize tumor killing potency and activate an anti-tumor immune response.
Despite the setback, Replimune’s CEO Sushil Patel emphasized the unmet need in advanced melanoma and the "compelling risk-benefit profile of RP1 observed in the IGNYTE trial." Patel stated that the company remains committed to working with the FDA to find an expeditious path forward for the treatment.
The negative market reaction reflects investor concerns about potential delays in bringing RP1 to market following the regulatory hurdle.
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