REPLReplimune Group, Inc.

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...

AbCellera, Replimune and Airbnb reached fresh highs as strong drug data, new funding and better-than-expected earnings boosted investor confidence.

The firm priced about 9.7 million shares at $12.06 each, in line with Friday’s closing price.

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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.

Replimune secures FDA approval for Tudriqev on its third attempt, making it the company’s first product on the market.

The rally showed that investors are paying more attention to fast-growing healthcare and digital media companies.

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

Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner. Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body. The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary.

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

Replimune, Snowflake, and Cloudflare shares surged to annual highs last week amid a series of positive company catalysts, Wall Street optimism, and earnings anticipation.

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...

Replimune stock soars after a FDA advisory committee votes that the company’s study on its skin cancer treatment is ‘clinically meaningful.’

Replimune (REPL) stock soared 94% after the company late Thursday reported a favorable outcome of th

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Cantor Fitzgerald said the positive panel outcome materially improves the chances of accelerated approval for Replimune's RP1 therapy ahead of the Aug. 2 FDA decision.

Replimune announced a favorable outcome for its melanoma drug following a meeting of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee.

Independent experts voted 10-3 despite regulators’ concern about the design of the company’s pivotal cancer trial.

Wall Street now views the path to clearance for RP1 as increasingly uncertain following two prior rejections.

The biotech is seeking approval for its first commercial product in combination with Bristol Myers Squibb’s Opdivo.

Replimune (NASDAQ: REPL) shares fell nearly 31% on Tuesday after US Food and Drug Administration (FDA) staff reviewers raised concerns over the effectiveness of the company’s lead cancer therapy, RP1, ahead of a key advisory committee meeting. The decline followed the release of FDA briefing...

Replimune’s melanoma treatment application, which was accepted by the FDA after a third submission, has come under renewed scrutiny after agency reviewers raised concerns about the trial design and the reliability of the reported response rates.

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