Replimune Group Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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| Item 7.01 | Regulation FD Disclosure. |
On November 21, 2024, Replimune Group, Inc. (the “Company”) issued a news release announcing certain updates with respect to RP1, the Company’s lead product candidate. A copy of such news release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
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.
The Company undertakes no obligation to update, supplement or amend the materials furnished herewith.
| Item 8.01 | Other Events. |
On November 21, 2024, the Company issued a news release announcing that it has submitted a biologics license application to the U.S. Food and Drug Administration (“FDA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | News Release dated November 21, 2024 | |
| 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: November 21, 2024 | By: | /s/ Sushil Patel |
| Sushil Patel | ||
| Chief Executive Officer | ||