Replimune Shares Plunge After FDA Setback and Class Action Threat
Replimune Shares Plunge Following FDA Announcement
On September 18, 2025, investors in Replimune Group, Inc. (NASDAQ: REPL) experienced a dramatic drop in stock value, plummeting approximately 45% during intraday trading. This alarming decline was triggered after the company revealed that its discussions with the FDA regarding a Biologics License Application for its leading drug candidate, RP1, did not present a clear path forward for accelerated approval.
The FDA's Recent Developments
The company had previously expressed optimism about its applications, especially following a Type A meeting held on September 16, 2025. However, the FDA's response proved to be a dent in that optimism, indicating that a definitive pathway had yet to be confirmed, casting doubt on RP1's viability for patients with advanced melanoma. This revelation came shortly after a class action lawsuit was filed against Replimune, alleging that the company had misled investors by portraying an exaggerated success narrative regarding the drug's prospects. In the aftermath of its previous July 22 FDA rejection, when the agency delivered a
Topics Financial Services & Investing）
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