Replimune hit by FDA setback as RP1 BLA receives CRL

Rhea-AI Filing Summary

On 21-Jul-2025 Replimune Group, Inc. (REPL) received a Complete Response Letter (CRL) from the U.S. FDA for its Biologics License Application seeking approval of oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The CRL means the agency will not approve the application in its current form and requires additional information before reconsideration. Specific deficiencies and next steps were not disclosed in the 8-K.

The company furnished, but did not “file,” a news release (Exhibit 99.1) under Item 7.01/8.01. No financial statements, earnings impact, or updated guidance were provided. The setback could delay potential commercialization and future revenue for RP1, increasing regulatory uncertainty and development costs.

Insights

Biotech Equity Analyst

TL;DR – FDA CRL materially delays RP1 approval, adding cost and uncertainty for REPL.

The CRL halts near-term commercialization prospects for RP1, Replimune’s lead asset. Without clarity on required data, timelines could slip 12-24 months, eroding first-mover advantage in oncolytic immunotherapy and pushing out potential revenue inflection. The absence of financial guidance compounds valuation pressure, as RP1 represents the bulk of the company’s projected cash flows. Investors should watch for a Type A meeting outcome and required clinical or CMC work, both of which could require additional capital.

Portfolio Manager – Healthcare Focus

TL;DR – Regulatory setback is clearly negative; risk-adjusted DCF must be revised down.

The filing confirms a material regulatory delay with no offsetting positives. Given RP1’s outsized contribution to REPL’s pipeline value, a CRL justifies multiple compression and may trigger sell-side estimate cuts. Liquidity appears adequate today, but extended development raises financing risk in 2026-2027. I view this as an impactful negative event requiring portfolio under-weighting until more regulatory visibility emerges.

false 0001737953 0001737953 2025-07-21 2025-07-21 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):  July 21, 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 July 22, 2025, Replimune Group, Inc. (the “Company”) issued a news release announcing that the U.S. Food and Drug Administration (the “FDA”) has issued a 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.

On July 21, 2025, the Company received a 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.

Exhibit No.		Description
99.1		News Release dated July 22, 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: July 22, 2025	By:	/s/ Sushil Patel
		Sushil Patel
		Chief Executive Officer

FAQ

Why did Replimune (REPL) file an 8-K on July 22 2025?

The company disclosed receipt of a Complete Response Letter from the FDA for its RP1 BLA.

What product is affected by the FDA’s CRL to Replimune?

The biologic RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma.

Does the 8-K include financial results or guidance?

No. The filing contains no financial data; it is limited to the regulatory update.

What is the immediate impact of a Complete Response Letter?

Approval is denied until Replimune addresses FDA deficiencies, delaying commercialization and potential revenue.

Where can investors read the full press release about the CRL?

The press release is furnished as Exhibit 99.1 to the Form 8-K.