Item 7.01 Regulation FD Disclosure . On April 10, 2026, Replimune Group, Inc. (the “Company”) issued a news release announcing that the U.S. Food and Drug Administration (the “FDA”) has issued a second Complete Response Letter regarding the Biologics License Application (“BLA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. A copy of such news release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly stated by specific reference in such filing.
REPL Replimune Group, Inc. - 8-K
Accession
0001104659-26-0421417.018.019.01
Item 7.01 - Regulation FD Disclosure
163 words
Item 8.01 - Other Events
38 words
Item 8.01 Other Events . On April 10, 2026, the Company received a second Complete Response Letter from the FDA regarding the Company’s BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
Item 9.01 - Financial Statements and Exhibits
27 words
Item 9.01 Financial Statements and Exhibits . Exhibit No. Description 99.1 News Release dated April 10, 2026 104 Cover page interactive data file (formatted as Inline XBRL)