CoverageForm 410-K10-Q8-K13D13G13F

REPL Replimune Group, Inc. - 8-K

Filed Apr 13, 2026. See issuer overview · financials · original on SEC.gov ↗
Accession
0001104659-26-042141
7.018.019.01

Item 7.01 - Regulation FD Disclosure

163 words

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.

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

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