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www.globenewswire.comHere are the latest publicly reported updates on Replimune (ticker: REPL) through April–May 2026:
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FDA status on RP1: In April 2026, Reuters-style summaries and investor notices indicated the FDA issued a Complete Response Letter (CRL) for the RP1 plus nivolumab BLA for advanced melanoma, with the agency citing data insufficiency for substantial evidence of effectiveness and changes in regulatory flexibility. Replimune stated the CRL necessitates adjustments to plans, including manufacturing and development timelines, and it signaled a potential path forward may require accelerated approval considerations or additional data.[1][4]
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Conference activity and updated data: Replimune publicly shared late-breaking biomarker and updated clinical data for RP1 plus nivolumab at SITC 2025, including evidence that RP1 may counter several mechanisms of resistance to PD-1 blockade and upregulate PD-1–responsive gene signatures. These results are part of ongoing discussions around RP1’s clinical profile and potential indications.[1]
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Regulatory interactions in 2025: The company reported progress from a Type A FDA meeting held in September 2025 to discuss the CRL and the BLA for RP1. The company described continued evaluation of the FDA’s feedback and noted uncertainty around pursing accelerated approval, while reaffirming interest in RP1’s risk-benefit profile and the need for effective melanoma therapies.[1]
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Related product candidates: Beyond RP1, Replimune is developing RP2 and RP3 to broaden its oncolytic immunotherapy platform, including efforts to address tumor types with historically lower immune responsiveness. RP2 includes components designed to enhance immune activation and potentially address additional targets.[1]
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Baseline financial/regulatory context: The company’s filings and press materials from 2024–2026 discuss topline IGNYTE trial data for RP1 plus nivolumab, showing meaningful response rates and durability in anti-PD-1–failed melanoma, which underpins the case for RP1 in combination strategies though regulatory acceptance has been challenging. Public disclosures in 2024–2026 reflect ongoing investor communications around regulatory milestones and development plans.[2]
If you’d like, I can compile a concise timeline with dates and document titles, or pull the most current official filings and press releases from Replimune’s investor relations site and the FDA to verify each item. I can also set up a quick alert summary if you want ongoing updates.
Citations:
- Latest updates and CRL status (April 2026; SITC 2025 data):[1]
- FDA meeting and 2025 regulatory context:[1]
- 2024–2026 IGNYTE trial data and regulatory disclosures:[2]
- RP2/RP3 development note:[1]