Replimune (NASDAQ: REPL) completes FDA Type A meeting on RP1 melanoma BLA

Rhea-AI Filing Summary

Replimune Group, Inc. reported that it completed a Type A meeting with the U.S. Food and Drug Administration on September 16, 2025. The meeting focused on the company’s Biologics License Application for RP1 in combination with nivolumab to treat advanced melanoma.

The company is evaluating the FDA’s feedback from this meeting to determine its next steps for the RP1 program. A news release with additional details was issued on September 18, 2025 and is included as an exhibit to this report.

Insights

Biotech regulatory analyst

Replimune completed an FDA Type A meeting on its RP1 melanoma BLA.

Replimune Group held a Type A meeting with the FDA about its Biologics License Application for RP1 plus nivolumab in advanced melanoma. Type A meetings typically address significant issues or stalled applications, so this interaction centers on resolving key questions around the filing.

The company states it is assessing the FDA’s feedback to determine next steps, which means no regulatory outcome is described yet. Investors will need to look to subsequent company communications or filings for clarity on whether the feedback supports, delays, or redirects the BLA strategy.

false 0001737953 0001737953 2025-09-16 2025-09-16 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

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):  September 16, 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 7.01 Regulation FD Disclosure.

On September 18, 2025, Replimune Group, Inc. (the “Company”) issued a news release announcing that it completed a Type A meeting with the U.S. Food and Drug Administration (the “FDA”) on September 16, 2025 regarding the Company’s Biologics License Application (“BLA”) for RP1 in combination with nivolumab for the treatment of advanced melanoma. The Company is evaluating the feedback from the FDA provided during the meeting to determine next steps. A copy of such news release regarding this meeting 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.

On September 16, 2025, the Company completed a Type A meeting with the FDA regarding the Company’s BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
99.1		News Release dated September 18, 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: September 18, 2025	By:	/s/ Sushil Patel
		Sushil Patel
		Chief Executive Officer

FAQ

What did Replimune Group (REPL) announce in this 8-K filing?

Replimune Group announced it completed a Type A meeting with the FDA about its Biologics License Application for RP1 plus nivolumab in advanced melanoma. The company is now evaluating FDA feedback to decide its next development and regulatory steps for this program.

What is the focus of Replimune’s BLA discussed with the FDA?

The Biologics License Application discussed with the FDA covers RP1 in combination with nivolumab for treating advanced melanoma. This meeting centered on that specific application, which is intended to support potential marketing authorization if regulatory requirements are ultimately satisfied.

When did Replimune hold the FDA Type A meeting on RP1?

Replimune held the Type A meeting with the FDA on September 16, 2025. The company later issued a news release on September 18, 2025 describing this interaction and furnished that release as an exhibit to the current report.

Did Replimune disclose the FDA’s conclusions on the RP1 BLA?

Replimune did not describe specific FDA conclusions in this report. It stated that it is evaluating the feedback received during the Type A meeting to determine next steps for the RP1 and nivolumab advanced melanoma Biologics License Application.

Where can investors find more details on Replimune’s FDA meeting?

Additional detail is contained in a news release dated September 18, 2025, which Replimune furnished as Exhibit 99.1. That exhibit accompanies the current report and provides further description of the FDA Type A meeting regarding the RP1 BLA.

Does this Replimune 8-K affect financial statements or earnings?

This report focuses on regulatory interactions around the RP1 Biologics License Application, not financial results. It does not present earnings, revenue, or balance sheet data, and instead highlights the completed Type A FDA meeting and related disclosure exhibit.