Welcome to our dedicated page for Replimune Group news (Ticker: REPL), a resource for investors and traders seeking the latest updates and insights on Replimune Group stock.
Replimune Group, Inc. reports clinical, regulatory and financial developments for a clinical-stage biotechnology business developing oncolytic immunotherapies for cancer. The company’s proprietary RPx platform uses an engineered HSV-1 backbone intended to promote tumor cell killing, immunogenic cell death and systemic anti-tumor immune responses.
Recurring Replimune news centers on RP1, or vusolimogene oderparepvec, including data from the IGNYTE clinical trial, combination use with nivolumab in advanced melanoma, Biologics License Application activity and FDA complete response letters. Updates also cover RP2 clinical data in advanced solid tumors, scientific presentations at oncology meetings, quarterly financial results, research and development spending, cash runway commentary and management presentations at healthcare conferences.
Replimune (NASDAQ: REPL) reported final first-in-human Phase 1 data for RP2, alone and with nivolumab, in 85 heavily pretreated patients with advanced solid tumors at the 2026 ASCO meeting.
RP2 showed objective responses, durable disease control, systemic immune activity, and a favorable safety profile, supporting an ongoing randomized Phase 2/3 uveal melanoma trial.
Replimune (NASDAQ: REPL) reported 3-year landmark overall survival data from the IGNYTE trial of RP1 plus nivolumab in anti–PD-1–failed advanced melanoma at the 2026 ASCO meeting.
Median overall survival reached 32.9 months; 3-year overall survival was 47.8% for all treated patients and 83.5% for responders. Objective response rate was 33.6% with a median duration of response of 24.8 months, and 44.8% of responders maintained responses at 3 years. A survival benefit was seen across key subgroups, with a predominantly Grade 1–2 safety profile and no Grade 5 events reported.
Replimune (NASDAQ: REPL) plans to resubmit its RP1 (vusolimogene oderparepvec) BLA in the coming days for use with nivolumab in advanced melanoma after anti-PD-1 progression. Following collaborative talks, the FDA agreed on a path forward and will prioritize the urgent review, supported by IGNYTE trial data.
Replimune (NASDAQ: REPL) will present multiple clinical updates at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 29–June 2, 2026. The company has two oral abstracts and four poster presentations covering 3‑year overall survival data for RP1 plus nivolumab, final Phase 1 RP2 safety/efficacy/biomarker results, and multiple ongoing RP1/RP2 studies across melanoma, solid tumors, HCC, and biliary tract cancer.
Oral presentations occur May 30 and May 31, 2026; poster sessions are scheduled across May 30–31 in Hall A and other ASCO session locations.
Replimune (NASDAQ: REPL) received a Complete Response Letter (CRL) from the FDA on April 10, 2026 for its BLA seeking approval of RP1 plus nivolumab in advanced melanoma. The company cites IGNYTE data showing a 34% response rate and median duration of response of 24.8 months, and says FDA review teams changed and declined regulatory flexibility. Replimune warns the CRL forces job cuts and a substantial scale-back of U.S. manufacturing and says accelerated approval is required for RP1's development to remain viable.
Replimune (Nasdaq: REPL) said its management team will present at two investor conferences in March 2026: a fireside chat at the Leerink Partners 2026 Global Healthcare Conference on March 9, 2026 at 2:20 pm EDT, and 1x1 meetings at the Jefferies 2026 Biotech on the Beach Summit on March 10, 2026.
Live webcast of the March 9 fireside chat will be available in the Investors section of Replimune's website, with a replay available for 30 days after the conference.
Replimune (Nasdaq: REPL) reported fiscal Q3 2026 results and a corporate update, highlighting an FDA PDUFA target action date of April 10, 2026 for the RP1 BLA resubmission and commercial readiness activities underway. The company drew $35M on an amended Hercules loan with potential $120M post-approval funding and extended debt repayment to 2027. Cash, cash equivalents and short-term investments were $269.1M as of Dec 31, 2025, down from $483.8M a year earlier, and the company expects funding into late Q1 2027 under the current plan. Clinical updates include IGNYTE-3 Phase 3 enrollment (~400 patients), acral melanoma ORR 44%, ARTACUS CSCC ORR 34.6% (CR 23.1%), and ongoing RP2 trials.
Replimune (Nasdaq: REPL) said company management will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2025 at 1:30 PM PT.
A simultaneous webcast will be available in the Investors section of replimune.com, and a replay will be available for 30 days following the conference.
Replimune (NASDAQ: REPL) presented late-breaking biomarker and updated clinical data for RP1 plus nivolumab at SITC 2025 on Nov 7, 2025. The IGNYTE trial update (abstract #1327) reported that RP1 appears to reverse multiple mechanisms of resistance to PD-1 blockade and upregulates gene signatures linked to PD-1 responsiveness. With an additional 7 months follow-up, the combination showed an objective response rate (ORR) of 33.6% and a median duration of response of 24.8 months. Consistent durability was observed across PD-L1–positive and PD-L1–negative tumors and in primary and secondary resistance settings. Two additional posters (abstracts 611 and 600) reported comparable efficacy by BRAF status and tolerability with extended RP1 dosing.
Replimune (Nasdaq: REPL) reported fiscal Q2 results for the period ended September 30, 2025 and provided a corporate update. The company said the FDA accepted the BLA resubmission for RP1 with a PDUFA date of April 10, 2026 and indicated the IGNYTE-3 trial could potentially support approval.
Clinical programs continue: IGNYTE-3 (RP1+nivolumab, ~400 patients, primary endpoint overall survival), RP2 REVEAL (metastatic uveal melanoma, ~280 patients), and multiple ongoing Phase 2 trials and presentations through SITC 2025. Financials: $323.6M cash as of Sept 30, 2025 and a Q2 net loss of $83.1M.