UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On August 6, 2026, Replimune Group, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has granted accelerated approval for TUDRIQEVTM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. In addition, the Company posted to its website a corporate presentation in connection with the approval. A copy of the corporate presentation is attached hereto as Exhibit 99.2 and is incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | News Release dated August 6, 2026 | |
| 99.2 | Company Presentation dated August 6, 2026 | |
| 104 | Cover page interactive data file (formatted as Inline XBRL) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| REPLIMUNE GROUP, INC. | ||
| Date: August 6, 2026 | By: | /s/ Sushil Patel |
| Sushil Patel | ||
| Chief Executive Officer | ||