Here are the latest updates I can share based on recent public reports:
Replimune Group (REPL) faced a Complete Response Letter from the FDA in April 2026 regarding RP1 plus nivolumab for advanced melanoma, prompting the company to reassess its path forward and consider alternatives such as accelerated approval pathways or strategy adjustments. This development significantly influenced near-term prospects and manufacturing plans. [source: Stocktitan summary of 2026-04-26 reporting on the CRL and related context][1]
In 2025 and early 2026, Replimune presented updated IGNYTE trial data and biomarker analyses at SITC 2025, highlighting that RP1 may help overcome resistance mechanisms to PD-1 blockade and modulate gene signatures associated with PD-1 responsiveness. This suggests potential activity in PD-1–refractory settings, though regulatory approval remained unresolved.[1]
The company has continued communications with the FDA, including a Type A meeting in September 2025 to discuss the CRL and determine a path forward, with emphasis on extraordinary unmet need in advanced melanoma and consideration of accelerated approval pathways, though a definitive regulatory path had not been confirmed.[1]
FDA-related disclosures from 2024 note topline results from the IGNYTE trial showing a subset of patients responding to RP1 plus nivolumab, with durability of responses lasting beyond six months in the central review, informing ongoing discussions about efficacy evidence.[2]
Other coverage summarized various market and media reactions to the FDA feedback, including stock movement alongside the regulatory uncertainty, and notes about RP2 and RP3 development as potential follow-ons to broaden application beyond melanoma.[3]
If you’d like, I can pull the most recent official press releases or filings (e.g., latest SEC/IR materials or FDA correspondence) and summarize them with citations. I can also track price/volatility snapshots around key announcements and create a concise timeline of regulatory events.
Follow Replimune Group, Inc. (REPL) news, including RP1 and RP2 clinical data, FDA BLA updates, trial milestones, financial results and key oncology conference events.
www.stocktitan.netnews
www.prnewswire.comOn June 6, 2024, the Company announced the topline results from the primary analysis of its IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. The results by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO 2024, with all responses lasting greater than 6 months from baseline.
www.sec.govFDA: Fda, in complete response letter: Data was insufficient to conclude substantial evidence of effectiveness of Replimune's vusolimogene oderparepvec. ...
www.marketscreener.comSep. 18, 2025 21:15
www.taiwannews.com.twStock screener for investors and traders, financial visualizations.
finviz.comGlobeNewswire specializes in the distribution and delivery of press releases, financial disclosures and multimedia content to the media and general public.
www.globenewswire.comThe Investor Relations website contains information about Replimune Group Inc.'s business for stockholders, potential investors, and financial analysts.
ir.replimune.comReplimune Group, Inc.: News, information and stories for Replimune Group, Inc. Nasdaq: REPL Nasdaq
uk.marketscreener.comGlobeNewswire specializes in the distribution and delivery of press releases, financial disclosures and multimedia content to the media and general public.
www.globenewswire.com