Replimune's shares plummet 45% after company says no pathway identified for lead drug RP1, securities class action pending.

Replimune Group's shares fell 45% after the company announced that the FDA did not determine a pathway for its lead drug RP1. A securities class action lawsuit alleges that Replimune misled investors by overstating the success of RP1, leading to a 77% stock price crash after the FDA rejected its application. The lead plaintiff deadline is September 22, 2025. Hagens Berman urges investors with substantial losses to contact the firm now.

Replimune Group Inc. (NASDAQ: REPL) saw its stock plummet by 45% on September 16, following the company's announcement that the FDA did not determine a pathway for its lead drug, RP1. The biotechnology company completed a Type A meeting with the FDA on September 16, where it discussed the complete response letter for its Biologics License Application (BLA) for RP1 in combination with nivolumab for treating advanced melanoma. However, the FDA indicated that a clear path forward under the accelerated approval pathway has not been established Replimune stock plunges after FDA meeting fails to clear path forward^[1].

The FDA's complete response letter (CRL) highlighted several issues with the pivotal IGNYTE trial, including concerns about the interpretability of the results and the design of the confirmatory trial, IGNYTE-3. The FDA raised questions regarding the contribution of components in combination therapies, which is crucial for accelerated approval FDA Issues CRL for RP1 in Advanced Melanoma^[3].

Replimune's CEO, Sushil Patel, stated that the company remains committed to working with the FDA to find an expeditious path forward for the treatment. However, the negative market reaction reflects investor concerns about potential delays in bringing RP1 to market following the regulatory hurdle.

Adding to the company's challenges, Levi & Korsinsky, LLP has notified investors of a class action securities lawsuit. The lawsuit alleges that Replimune misled investors by overstating the success of RP1, leading to a 77% stock price crash after the FDA rejected its application. Investors who suffered losses between November 22, 2024, and July 21, 2025, have until September 22, 2025, to request that the Court appoint them as lead plaintiffs Levi & Korsinsky Notifies Replimune Group, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline – REPL^[2].

Hagens Berman urges investors with substantial losses to contact the firm now. The company's stock price has been volatile, reflecting the uncertainty surrounding the FDA's decision and the pending securities lawsuit.