Replimune Shares Crash 45% After FDA Discusses RP1 Approval

Replimune Group's shares plummeted 45% after a meeting with the FDA regarding its BLA for lead drug candidate RP1, with no clear path for accelerated approval. This comes after a securities class action lawsuit alleging the company misled investors about RP1's success, resulting in a 77% stock price crash. The Lead Plaintiff deadline is September 22, 2025.

Replimune Group Inc.'s (NASDAQ: REPL) shares plunged 45% on September 16 following a meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for its lead drug candidate RP1. The meeting, a Type A discussion, aimed to address the FDA's Complete Response Letter (CRL) issued on July 22, which cited insufficient clinical evidence from Replimune's Phase 2 study FDA Grants Type A Meeting to Discuss RP1 Plus Nivolumab in Advanced Melanoma^[1].

The FDA meeting did not clear a path forward for accelerated approval, leaving Replimune's future uncertain. The company's stock has been volatile since the CRL was issued, dropping over 70% on July 22 and another 40% on September 18 BREAKING: Replimune Shares Drop Over 40%; Investors Should Contact Block & Leviton By September 22nd To Join Securities Fraud Lawsuit^[2]. The recent decline follows a securities class action lawsuit alleging that Replimune misled investors about RP1's success Replimune stock plunges after FDA meeting fails to clear path forward^[3].

The lawsuit, filed by Block & Leviton, alleges material false and misleading statements about the IGNYTE clinical trial and the prospects for regulatory approval of RP1 in combination with nivolumab. Investors who purchased Replimune Group Inc. common stock between November 22, 2024, and July 21, 2025, may be eligible to participate in the lawsuit BREAKING: Replimune Shares Drop Over 40%; Investors Should Contact Block & Leviton By September 22nd To Join Securities Fraud Lawsuit^[2].

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 Replimune stock plunges after FDA meeting fails to clear path forward^[3].

The deadline to seek appointment as lead plaintiff in the lawsuit is September 22, 2025 BREAKING: Replimune Shares Drop Over 40%; Investors Should Contact Block & Leviton By September 22nd To Join Securities Fraud Lawsuit^[2]. Investors who have lost money in their Replimune Group, Inc. investment should contact Block & Leviton to learn more about how they might recover those losses BREAKING: Replimune Shares Drop Over 40%; Investors Should Contact Block & Leviton By September 22nd To Join Securities Fraud Lawsuit^[2].