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. (Nasdaq: REPL) generates frequent news as a clinical stage biotechnology company developing novel oncolytic immunotherapies based on its proprietary HSV‑1‑derived RPx platform. Headquartered in Woburn, Massachusetts and founded in 2015, the company focuses on product candidates such as RP1 (vusolimogene oderparepvec) and RP2, which are being studied across multiple difficult‑to‑treat cancers.
News related to Replimune commonly covers clinical trial updates from programs like IGNYTE, IGNYTE‑3, ARTACUS and REVEAL. These updates include data presentations at major medical meetings, such as the Society for Immunotherapy of Cancer (SITC) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress, where the company has reported biomarker findings, response rates, durability of responses and safety data for RP1 plus nivolumab in advanced melanoma and non‑melanoma skin cancers.
Another major category of news involves regulatory milestones. Replimune has announced the FDA’s Complete Response Letter for the Biologics License Application (BLA) for RP1 in combination with nivolumab in advanced melanoma, subsequent Type A meetings with the FDA, and the agency’s acceptance of a BLA resubmission with a specified PDUFA target action date. These items are closely followed by investors and the oncology community because they reflect the evolving regulatory path for RP1.
Replimune’s news flow also includes corporate and financial updates, such as quarterly financial results, cash runway commentary, and equity‑based inducement grants to employees, as well as participation in investor conferences like the J.P. Morgan Healthcare Conference. Together, these announcements provide insight into the company’s operational progress, clinical development priorities and interactions with regulators.
Investors, clinicians and other stakeholders can use this news feed to track key developments around Replimune’s RPx platform, its lead programs in advanced melanoma and skin cancers, and the broader pipeline in metastatic uveal melanoma, hepatocellular carcinoma and biliary tract cancer.
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.
Replimune (NASDAQ: REPL) announced that the U.S. Food and Drug Administration has accepted the BLA resubmission for RP1 in combination with nivolumab to treat advanced melanoma in patients who progress on an anti‑PD‑1 containing regimen.
The FDA set a PDUFA target action date of April 10, 2026 under a Class II resubmission timeline. Replimune said the resubmission includes additional information, data and analyses and that the FDA views it as a complete response to the complete response letter issued in July 2025.
Replimune (NASDAQ: REPL) presented an ad hoc analysis from the IGNYTE phase 2 cohort at ESMO Congress 2025 showing activity of RP1 plus nivolumab in acral melanoma (Poster 1644P). The cohort had an objective response rate (ORR) of 44% (8/18) and a median duration of response of 11.9 months (95% CI lower bound 3.9 months, upper bound not reached). Safety was described as favorable with mostly transient grade 1–2 treatment‑related adverse events. The company noted ongoing phase 3 IGNYTE‑3 enrollment in post‑anti‑PD1/CTLA‑4 progressed melanoma and an additional NMSC poster (1661P) at ESMO.
Replimune (NASDAQ: REPL) has completed a Type A meeting with the FDA on September 16th, 2025, to discuss the Complete Response Letter (CRL) received for their RP1 therapy. The meeting focused on their Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.
The company is currently evaluating the FDA's feedback, noting that a path forward under the accelerated approval pathway remains undetermined. CEO Sushil Patel emphasized strong support from the melanoma community and highlighted the unmet need in advanced melanoma treatment, citing positive risk-benefit profile observed in the IGNYTE trial.