Glancy Prongay Wolke & Rotter LLP announced a class action lawsuit against Replimune Group, Inc. for alleged securities fraud. The company made misleading statements about its FDA drug application (RP1 BLA) between October 2025 and April 2026. The FDA rejected the application on April 10, 2026, citing undisclosed study design deficiencies and insufficient patient data (40 of 400 planned patients), causing the stock to plummet 19.46% on the day and an additional 64.29% decline by April 13, 2026. Investors who purchased shares during the class period are urged to file lead plaintiff motions by October 5, 2026.

A class action lawsuit has been filed against Replimune Group, Inc. alleging that the company made false and misleading statements regarding its FDA submission for RP1-104. The complaint claims Replimune failed to disclose study design concerns from the FDA and submitted data from an early analysis with only 40 patients instead of the planned 400, which likely caused FDA rejection of the BLA. Investors who purchased securities between October 20, 2025 and April 10, 2026 are eligible to join the case.

Law firm Bragar Eagel & Squire is investigating Replimune Group Inc. following FDA briefing documents that deemed the company's mid-stage study for its skin cancer drug RP1 as 'not interpretable.' The FDA assessment raised concerns about the study's ability to verify efficacy results. Following the news on July 28, 2026, Replimune's stock price dropped 37.89% in intraday trading.

Replimune's FDA advisory committee voted 10-3 that efficacy results from the IGNYTE study for RP1 (in combination with nivolumab) are evaluable and clinically meaningful for treating advanced melanoma in anti-PD-1 therapy-resistant patients. The FDA's target action date for the BLA resubmission is August 2, 2026.

Law firm Bragar Eagel & Squire is investigating Replimune Group Inc. following FDA briefing documents that deemed the company's mid-stage study for its skin cancer drug RP1 as 'not interpretable.' The FDA assessment raised concerns about the study's ability to verify efficacy results. Following the announcement on July 28, 2026, Replimune's stock price dropped 37.89% in intraday trading.

The Schall Law Firm is investigating Replimune Group, Inc. for potential securities law violations related to allegedly false or misleading statements. The company received a complete response letter from the FDA regarding its BLA for RP1 in combination with nivolumab for advanced melanoma treatment, citing disagreement over data suitability. Following this announcement on April 10, 2026, Replimune's stock price fell approximately 64.3% on April 13, 2026.

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Replimune announced it received a Complete Response Letter (CRL) from the FDA for its RP1 biologics license application in combination with nivolumab for advanced melanoma treatment. Despite the drug showing a 34% response rate with 24.8-month median duration in the IGNYTE trial, the FDA rejected approval. The company criticized the FDA's regulatory process and announced it will scale back operations and eliminate jobs, stating the treatment will not be available to patients due to systemic failures rather than drug efficacy.

The global oncolytic virotherapy market is projected to grow from USD 49.73 million in 2025 to USD 153.31 million by 2031, with a CAGR of 20.64%. Growth is driven by rising cancer incidence, advances in genetic engineering, and synergistic combination therapies with checkpoint inhibitors. However, host immune system challenges and premature viral clearance remain significant obstacles to market expansion.

Replimune presented biomarker data showing RP1 plus nivolumab can potentially reverse resistance mechanisms to PD-1 blockade in advanced melanoma, demonstrating a 33.6% response rate and 24.8-month median response duration.

Replimune Group's stock surged after the FDA accepted its resubmitted Biologics License Application for RP1, an investigational drug targeting advanced melanoma when combined with Bristol Myers Squibb's Opdivo.

Replimune Group resubmitted a Biologics License Application to the FDA for RP1, an oncolytic immunotherapy for advanced melanoma patients who progressed on anti-PD-1 therapy. The PDUFA date is set for April 10, 2026.