Common Stock, par value $0.001 per share
- Symbol
- REPL
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01, 9.01 · 8-K
Replimune Group, Inc.
REPLNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On July 30, 2026, Replimune Group, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (the “Advisory Committee”) met to discuss the Company’s Biologics License Application (“BLA”) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the trea…
Company context
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Current securities
Registered securities in this filing
REPLIMUNE GROUP, INC. · 8-K · Filed 2026-07-31
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On July 30, 2026, Replimune
Group, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (the “Advisory Committee”) met to discuss the Company’s Biologics License Application
(“BLA”) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The Advisory Commitee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful.
A copy of the press release announcing the results of the meeting is attached as Exhibit 99.1 hereto and is incorporated by reference
herein.
Filed exhibits (1)
EX-99.1 2 tm2621708d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma Advisory Committee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful WOBURN, Mass., July 30, 2026 (GLOBE NEWSWIRE) - Replimune Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the outcome of today's meeting of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy. The committee discussed two topics: (1) whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population; and (2) the clinical meaningfulness of the response rate and du…
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