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REPLIMUNE GRP (REPL)
Key Performance
More- Earnings Score: 35
- Momentum Score: 57
- True Yield: N/A
- Financial Health Score: 0
Latest Research & News
A class action lawsuit has been filed against Replimune Group Inc. for allegedly making materially false statements regarding its Biologics License Application (BLA). The lawsuit claims the company failed to disclose that FDA study design concerns were not addressed and that submitted data from an early analysis included only 40 of 400 planned patients, likely causing FDA rejection of the BLA. Investors who purchased securities between October 20, 2025 and April 10, 2026 can apply to be lead plaintiff by October 5, 2026.
10/02/2026, 2:44 PM • GlobeNewswire
Pomerantz Law Firm has filed a class action lawsuit against Replimune Group, Inc. following the FDA's rejection of the company's Biologics License Application for RP1 in combination with nivolumab on April 10, 2026. The FDA cited deficiencies in clinical studies and stated the evidence did not meet approval standards. The stock price fell 19.46% on the announcement and an additional 64.29% days later, totaling an 83.75% decline from $4.76 to $1.70 per share. Investors who purchased securities during the class period have until October 5, 2026, to request Lead Plaintiff status.
09/15/2026, 6:13 PM • GlobeNewswire
Pomerantz Law Firm has filed class action lawsuits against ARS Pharmaceuticals, Inc. and other companies for alleged securities fraud. ARS's stock fell 23.91% after the company failed to secure expanded insurance coverage for its epinephrine nasal spray (neffy) through CVS Caremark by the July 1, 2026 deadline. Investors have until October 5, 2026 to join the class action.
09/15/2026, 6:11 PM • GlobeNewswire
A securities class action has been filed against Replimune Group, Inc. for allegedly failing to disclose regulatory concerns about its RP1 trial design to shareholders. The lawsuit claims the company built its regulatory strategy around single-arm trial designs that the FDA had already questioned, including response criteria inconsistent with RECIST v1.1 standards. Investors who purchased REPL shares between October 20, 2025 and April 10, 2026 experienced significant losses, with the stock declining 84.16% during the class period.
09/14/2026, 12:57 PM • GlobeNewswire
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
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
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
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
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'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
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
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
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 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
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
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MoreInformation as of 10/01/2026
Company Profile
Replimune Group, Inc., a clinical-stage biotechnology company, focuses on the development and commercialization of oncolytic immunotherapies to treat cancer in the United States and the United Kingdom. The company's proprietary oncolytic immunotherapy product candidates are designed and intended to activate the immune system against cancer. Its lead product candidate is RP1, a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF for a range of solid tumors. The company is also developing RP2 that expresses an anti-CTLA-4 antibody-like protein to block the inhibition of the immune response otherwise caused by CTLA-4. The company was founded in 2015 and is headquartered in Woburn, Massachusetts.
Key Executives
- Sushil Patel
- Philip Astley-Sparke
- Konstantinos Xynos
- Emily Luisa Hill
- Nina Aragam
Current Ownership Distribution
- Institutions1.2B (78.82%)
- Mutual Funds312.9M (19.75%)
- Insiders22.6M (1.43%)
- Other0 (0.00%)