REPL gets FDA BLA resubmission acceptance for RP1 + nivolumab

Rhea-AI Filing Summary

Replimune Group, Inc. (REPL) announced a key regulatory milestone. The FDA accepted the company’s resubmission of its Biologics License Application for RP1 in combination with nivolumab to treat patients with advanced melanoma. The FDA set a PDUFA date of April 10, 2026 based on a Class II resubmission timeline.

The acceptance confirms the application is filed for review and establishes a clear decision date. Replimune furnished a related news release as Exhibit 99.1. Outcomes will depend on the FDA’s review of the RP1 plus nivolumab data package.

Insights

Biotech regulatory analyst

BLA resubmission accepted; FDA decision targeted for April 10, 2026.

Replimune disclosed that the FDA accepted its resubmitted BLA for RP1 + nivolumab in advanced melanoma, assigning a April 10, 2026 PDUFA under a Class II resubmission. Acceptance means the filing is administratively complete and under review.

The business implication is a defined regulatory timeline; commercial impact depends on the ultimate approval decision and label details, which are not addressed here. No pricing, sales, or post-approval commitments are discussed in the excerpt.

Key milestones are the ongoing FDA review and the PDUFA action date on April 10, 2026. Any advisory committee or additional information requests would be determined by the FDA and are not indicated in this excerpt.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  October 20, 2025

REPLIMUNE GROUP, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38596		82-2082553
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

500 Unicorn Park Drive

Suite 303

Woburn, MA 01801

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (781) 222-9600

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		REPL		The Nasdaq Stock Market LLC (Nasdaq Global Select Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

On October 20, 2025, Replimune Group, Inc. (the “Company”) issued a news release announcing that the U.S. Food and Drug Administration (the “FDA”) accepted the Company’s resubmission of the Biologics License Application for RP1 in combination with nivolumab for patients with advanced melanoma. The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.

A copy of the news release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
99.1		News Release dated October 20, 2025
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: October 20, 2025	By:	/s/ Sushil Patel
		Sushil Patel
		Chief Executive Officer