Bronstein, Gewirtz & Grossman LLC Urges Replimune Group, Inc. Investors to Act: Class Action Filed Alleging Investor Harm

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 address FDA study design concerns and submitted data from an early analysis with only 40 patients instead of the planned 400, which likely led to BLA rejection. Investors who purchased securities between October 20, 2025 and April 10, 2026 are encouraged to join the case.

09/10/2026, 12:00 PM • GlobeNewswire

Bronstein, Gewirtz & Grossman LLC Urges Replimune Group, Inc. Investors to Act: Class Action Filed Alleging Investor Harm

A class action lawsuit has been filed against Replimune Group, Inc. alleging securities fraud. The complaint claims the company made false statements about its business operations and failed to disclose FDA study design concerns and deficiencies in its BLA submission. The lawsuit covers investors who purchased Replimune securities between October 20, 2025 and April 10, 2026.

09/03/2026, 12:00 PM • GlobeNewswire

Deadline Alert: Replimune Group, Inc. (REPL) Shareholders Who Lost Money Urged To Contact Glancy Prongay Wolke & Rotter LLP About Securities Fraud Lawsuit

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.

08/31/2026, 2:50 PM • GlobeNewswire

Bronstein, Gewirtz & Grossman LLC Urges Replimune Group, Inc. Investors to Act: Class Action Filed Alleging Investor Harm

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.

08/27/2026, 12:00 PM • GlobeNewswire

Bragar Eagel & Squire, P.C. is Investigating Replimune Group Inc. on Behalf of Replimune Stockholders and Encourages Investors to Contact the Firm

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.

08/05/2026, 5:52 PM • GlobeNewswire

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

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.

07/30/2026, 6:15 PM • GlobeNewswire

Bragar Eagel & Squire, P.C. is Investigating Replimune Group Inc. on Behalf of Replimune Stockholders and Encourages Investors to Contact the Firm

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.

07/30/2026, 5:48 PM • GlobeNewswire

REPL Investors Have Opportunity to Join Replimune Group, Inc. Fraud Investigation with the Schall Law Firm

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.

05/17/2026, 9:49 PM • GlobeNewswire

Oncolytic Virus Immunotherapy Market Landscape Report 2026: A $5 Opportunity by 2031 - Technology Platforms, Approved Therapy Dosage, Price & Clinical Trials Insights

The global oncolytic virus immunotherapy market is projected to reach over $5 billion by 2031, with three approved therapies and more than 150 candidates in clinical trials. Major pharmaceutical companies and biotechnology firms are advancing combination therapies and strategic partnerships to address cancer treatment challenges, with significant clinical development underway across multiple indications.

04/21/2026, 4:14 AM • GlobeNewswire

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

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.

04/10/2026, 5:02 PM • GlobeNewswire

Oncolytic Virotherapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

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.

01/23/2026, 5:52 AM • GlobeNewswire

Replimune Presents Late-Breaking Abstract and Additional Posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025)

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.

11/07/2025, 4:45 PM • GlobeNewswire

Why Replimune Stock Was Soaring Today

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.

10/20/2025, 4:10 PM • The Motley Fool

Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma

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.

10/20/2025, 7:00 AM • GlobeNewswire

Replimune Highlights Acral Melanoma Data for RP1 plus Nivolumab at the ESMO Congress 2025

Replimune reported positive phase 2 clinical trial results for RP1, an oncolytic immunotherapy, when combined with nivolumab in treating acral melanoma. The treatment showed a 44% objective response rate and a favorable safety profile for patients who had progressed on previous therapies.

10/19/2025, 8:00 AM • GlobeNewswire