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WOBURN, Mass., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present in a fireside chat at the Cantor Global Healthcare Conference on Thursday, September 10 at 9:10 AM ET. A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay will be availa

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TUDRIQEV™ in combination with nivolumab receives FDA accelerated approval and will launch within 60 days Michelle DiNapoli appointed as Chief Commercial Officer Recently completed financing extends cash runway to support commercial launch and confirmatory trial WOBURN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fisca

Replimune (REPL) reported fiscal Q1 net loss Friday of $0.72 per diluted share, narrowing from a los

Replimune Group (NasdaqGS:REPL) received FDA accelerated approval for TUDRIQEV (RP1) in combination with nivolumab to treat advanced cutaneous melanoma after anti PD 1 therapy. This marks the first FDA approval for Replimune and follows an advisory committee review and complex regulatory process. The decision allows near term commercialisation and puts fresh focus on ongoing confirmatory trials and related legal and regulatory matters. Readers looking for more ideas in adjacent areas of...

REPL's RP1 secures FDA approval for advanced melanoma, easing regulatory uncertainty. The company expands its oncolytic immunotherapy pipeline.

Replimune’s Tudriqev was granted accelerated approval by the FDA earlier this week, following two prior complete response letters and a 10-3 advisory committee vote in late July recommending the therapy.

FDA grants Replimune accelerated approval for TUDRIQEV in combination with nivolumab to treat advanced cutaneous melanoma.

Food and Drug Administration has approved Replimune's drug ‌for a difficult-to-treat form of skin ‌cancer, the company said on Thursday, giving the ​biotech firm its first marketed product after years of regulatory setbacks. Replimune was seeking accelerated approval for RP1, now known as Tudriqev, ‌in combination with ⁠Bristol Myers Squibb's immunotherapy, Opdivo, in advanced melanoma in patients whose ⁠tumors grew despite prior treatment.

Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEVTM (vusolimogene oderparepvec-wtpg), previously referred to as RP1,

Replimune said the U.S. Food and Drug Administration granted accelerated approval for TUDRIQEV, previously known as RP1, in combination with nivolumab.

The brokerage expects Replimune’s RP1 drug to see strong demand if approved, citing its relative ease of access and favorable safety profile.

In late July 2026, Replimune Group reported that the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10–3 that efficacy results from its single-arm IGNYTE trial of RP1 with nivolumab in anti-PD-1–refractory advanced melanoma are evaluable and clinically meaningful, ahead of an August 2, 2026 target FDA action date. The discussion highlighted how regulators weigh response durability and systemic anti-tumor activity from non-randomized data, a critical issue for...