Common Stock, par value $0.001 per share
- Symbol
- REPL
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Replimune Group, Inc.
REPLNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On July 30, 2026, Replimune Group, Inc. (the “Company”) will attend a meeting with the U.S. Food and Drug Administration's (“FDA”) Cellular, Tissue, and Gene Therapies Advisory Committee to discuss the Company’s Biologics License Application (“BLA”) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.…
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 2026-07-30
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On July 30, 2026, Replimune Group, Inc. (the “Company”)
will attend a meeting with the U.S. Food and Drug Administration's (“FDA”) Cellular, Tissue, and Gene Therapies Advisory Committee
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 Company has made available a copy of the presentation slides to be presented
at the meeting. The presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company undertakes no obligation
to update, supplement or amend the materials attached hereto.
The information contained in this Item 7.01 and
in the accompanying Exhibit 99.1 shall not be incorporated by reference into any filing of the Company, whether made before or after the
date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such
filing. The information in this Item 7.01 and the accompanying Exhibit 99.1 shall not be deemed to be “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended.
Filed exhibits (1)
EX-99.1 2 tm2621663d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 CC-1 Vusolimogene oderparepvec-wtpg (TUDRIQEV ) in Combination with Nivolumab for the Treatment of Adults with Unresectable Advanced Cutaneous Melanoma July 30, 2026 United States Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee ────────────────────────────────────────────────────────── CC-2 Introduction Kari Jeschke, MA Senior Vice President, Regulatory Affairs, Replimune, Inc. CC-3 Melanoma Community Support for Urgent Access to RP1 CC-4 TUDRIQEV is indicated in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with an anti-programmed death receptor-1 (PD-1) based regimen Proposed Indication Statement CC-5 Favorable Benefit-Risk for Accelerated Approval IGNYTE-3 randomized confirmatory trial ongoing with OS data expected in 2030 UNMET NEED: SERIOUS, LIFE-THREATENING DISEASE EFFICACY Adequate and Well-controlled Trial Supporting Evidence IGNYTE ORR: 33.6% (95% CI: 25.8, 42) DoR: 24.8 months (95% CI: 14.1, NE) MOA/Biological Plausi…
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