Replimune Group, INC 8-K filings

Replimune Group announced FDA accelerated approval for TUDRIQEV in combination with nivolumab for advanced melanoma, alongside a $150 million financing to support commercial launch and clinical trials.

Replimune Group, Inc. announced the pricing of an underwritten offering of common stock and pre-funded warrants, raising approximately $150 million.

Replimune Group, Inc. presented data on RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma to the FDA's Advisory Committee.

Replimune Group announced fiscal year 2026 financial results and provided corporate updates, including the FDA's acceptance of the BLA resubmission for RP1 in advanced melanoma with a target action date of August 2, 2026.

The FDA has accepted Replimune's resubmitted Biologics License Application for RP1 in advanced melanoma with a goal date of August 2, 2026.

Replimune Group, Inc. announced it will resubmit its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma following productive FDA discussions.

Replimune Group, Inc. announced an amendment to its loan agreement with Hercules Capital, extended its cash runway, and reported fiscal third quarter 2026 financial results while awaiting an FDA decision on RP1 for advanced melanoma.

Replimune Group, Inc. provides an updated corporate presentation highlighting recent business and strategic developments, positive clinical data for RP1 and RP2, and readiness for commercial launch.

Replimune Group, Inc. announced its fiscal second quarter 2026 financial results and provided an update on its clinical programs, including the FDA's acceptance of the BLA resubmission for RP1 with a PDUFA date of April 10, 2026.

Replimune Group announced the FDA accepted its Biologics License Application resubmission for RP1 in advanced melanoma, setting an April 10, 2026 PDUFA date.

Replimune Group, Inc. completed a Type A meeting with the FDA regarding its Biologics License Application for RP1 in advanced melanoma, but a path for accelerated approval is not yet determined.

Replimune Group, Inc. announced a critical Type A meeting with the FDA to discuss the Complete Response Letter for its RP1 BLA in advanced melanoma, with the CEO stating the program's viability hinges on accelerated approval.

Replimune Group, Inc. announced its fiscal first quarter 2026 financial results and a Complete Response Letter from the FDA for its RP1 BLA in advanced melanoma.

Replimune Group, Inc. announced that the FDA issued a Complete Response Letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma, citing issues with the IGNYTE trial and confirmatory study design.

Replimune Group, Inc. announced it hosted an Investor Day on June 24, 2025, making the presentation and webcast available online for investor review.

Replimune Group, Inc. announced its financial results for the fourth fiscal quarter and year ended March 31, 2025, and provided a business update, highlighting the progress of RP1 and RP2 clinical trials and commercial readiness for RP1 launch.

Replimune Group, Inc. expands its Board of Directors with the appointment of Michael Goller and enters into an agreement granting Baker Brothers Life Sciences resale registration rights for their shares.

Replimune Group, Inc. reported its fiscal third quarter 2025 financial results, highlighted by FDA priority review of RP1 and enrollment progress in clinical trials.

The FDA has accepted Replimune's BLA for RP1 in combination with nivolumab for advanced melanoma, granting priority review with a PDUFA action date of July 22, 2025.

Replimune Group corrected a filing to increase the maximum beneficial ownership threshold for pre-funded warrants from 9.99% to 19.99% and completed a public offering of common stock and pre-funded warrants, raising approximately $155.8 million.

Replimune Group, Inc. has successfully priced a public offering of common stock and pre-funded warrants, expected to generate approximately $155.8 million in net proceeds.

Replimune Group has amended its sales agreement to reduce the aggregate offering amount of its at-the-market offering from $100 million to $89 million and has suspended the current prospectus.

Replimune has submitted a biologics license application to the FDA for RP1 in combination with nivolumab for advanced melanoma and has received Breakthrough Therapy designation.

Replimune announced its fiscal second quarter 2025 financial results, highlighted by progress towards a BLA submission for RP1 and positive clinical trial data.

Replimune Group, Inc. held its annual meeting of stockholders on September 4, 2024, where directors were elected, the auditor was ratified, and executive compensation was approved on an advisory basis.

Replimune reported positive topline data from its IGNYTE trial for RP1 in melanoma, secured significant funding, and is advancing its pipeline with key clinical trial milestones.

Replimune Group, Inc. has announced a $100 million private placement to support the commercialization of its lead candidate, RP1, in skin cancers.

Replimune's RP1 combined with nivolumab shows a 33.6% overall response rate in anti-PD1 failed melanoma patients, with all responses lasting over six months.

Replimune presented promising clinical data for its RP1 and RP2 programs at the 2024 ASCO Annual Meeting, showing positive response rates in melanoma and uveal melanoma.

Replimune reported its fiscal year 2024 financial results, highlighted progress in its clinical trials, and anticipates key milestones in the coming months.