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

REPL FINAL DEADLINE ALERT: Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman

Replimune's stock plummeted 45% after the FDA rejected its Biologics License Application for RP1, a cancer drug, citing inadequate trial design. A securities class action lawsuit alleges the company misled investors about the drug's prospects.

09/21/2025, 11:20 AM • GlobeNewswire

SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Replimune

Faruqi & Faruqi, LLP is investigating potential securities claims against Replimune Group after the FDA issued a Complete Response Letter for their RP1 Biologics License Application, causing the stock to drop over 73%.

09/21/2025, 7:40 AM • GlobeNewswire

מחר המועד האחרון לתביעה נגד REPL: רוזן, יועץ למשקיעים מיומן, מעודד את משקיעי Replimune Group, Inc. שצברו הפסדים של יותר מ- 100 אלף דולר להבטיח ייעוץ לפני המועד האחרון החשוב בתביעה ייצוגית בניירות ערך שהוגשה ראשונה על ידי המשרד – REPL

Rosen Law Firm alerts investors of Replimune Group and RxSight who suffered losses over $100,000 about an upcoming September 22, 2025 deadline for filing securities class action lawsuits related to allegedly misleading statements.

09/21/2025, 6:09 AM • GlobeNewswire

REPL DEADLINE TOMORROW: ROSEN, SKILLED INVESTOR COUNSEL, Encourages Replimune Group, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm – REPL

Rosen Law Firm reminds Replimune Group investors of an important September 22, 2025 deadline for a securities class action lawsuit, alleging the company made false or misleading statements about its IGNYTE trial prospects.

09/21/2025, 6:09 AM • GlobeNewswire

REPLIMUNE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Replimune Group, Inc. and Encourages Investors to Contact the Firm Before September 22nd

A class action lawsuit has been filed against Replimune Group, Inc. alleging false statements about the IGNYTE trial's prospects, which the FDA deemed inadequate and not well-controlled.

09/17/2025, 6:00 PM • GlobeNewswire