Latest Replimune News & Updates

See the latest news and media coverage for Replimune. We track all announcements, press releases, and industry mentions in real time, all in one place.

Replimune

Clinical-stage biotech company developing oncolytic immunotherapies

replimune.com

Headquarters: Woburn, United States
Founded year: 2015
Company type: Public company
Number of employees: 300–500
Industry: Pharmaceuticals

Last updated Today

Latest news about Replimune

In short: Replimune secured a 10-3 favorable FDA advisory committee vote for its RP1 melanoma treatment despite previous regulatory setbacks.

Company announcements

July 31 Replimune

Replimune announces favorable FDA advisory committee vote for RP1

The FDA advisory committee voted 10 to 3 that the IGNYTE study's efficacy results are evaluable and clinically meaningful, with an action date of August 2, 2026.

June 26 Replimune

Replimune announces FDA acceptance of RP1 BLA resubmission

The FDA decision is expected by August 2, 2026, with an advisory committee meeting in late July.

May 31 Replimune

Replimune presents final RP2 first-in-human data

RP2 alone and with nivolumab achieved objective response rates of 19%, with durable responses and a tolerable safety profile in heavily pretreated patients.

May 30 Replimune

Replimune presents 3-year survival data from IGNYTE trial

In anti-PD-1-failed melanoma, RP1 plus nivolumab achieved median overall survival of 32.9 months, with 47.8% of patients alive at 3 years and 83.5% of responders.

Media coverage

July 31 Seeking Alpha

At a glance: stocks gapping up premarket

Track Friday’s biggest premarket gap-up stocks as index futures rise on tech strength after Amazon earnings.

July 30 Politico

Replimune gets a favorable vote after Capricor falls short

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 Thursday in favor of the clinical benefit of Replimune's investigational treatment for advanced melanoma...

July 30 BioWorld

Replimune's RP-1 for melanoma wins over FDA adcom

Following two complete response letters in the past year, Replimune Group Inc.'s RP-1 (suvolimogene oderparepvec) for unresectable metastatic cutaneous melanoma refractory to PD-1 therapy cleared...

July 29 STAT

Capricor and Replimmune face FDA advisory panels

Advisers question Capricor's Duchenne data while Replimmune presents melanoma results, and a fugitive biotech executive is unmasked.

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