Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-078009

Filed: 2026-06-26

Period: 2026-06-26

CIK: 0001737953

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2619037d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2619037d1_ex99-1.htm)

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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): June 26, 2026

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 June 26, 2026, Replimune

Group, Inc. (the “Company”) issued a news release announcing that the U.S. Food and Drug Administration has accepted for review

the resubmission of the Biologics License Application 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 9.01 Financial Statements and Exhibits.

Exhibit No.

Description

99.1

News Release dated June 26, 2026

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: June 26, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2619037d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Replimune Announces FDA Acceptance of RP1 Biologics

License Application Resubmission for Advanced Melanoma

FDA decision expected

by August 2, 2026

WOBURN, Mass., June 26, 2026 (GLOBE NEWSWIRE) - Replimune Group,

Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today

that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for

RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete,

class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

“We are pleased that the FDA has demonstrated urgency in reconsidering

the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from

the broader melanoma community,” said Sushil Patel, Ph.D., CEO of Replimune. “We look forward to a productive scientific and

clinical discussion on the risk/benefit profile of RP1 in this difficult to treat setting.”

The resubmission seeks accelerated approval of RP1 in advanced melanoma

based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an

anti-PD-1 containing regimen.

About Advanced Melanoma

Melanoma is the fifth most common cancer in the United States, with

approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually.

Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint

blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population

in need of effective therapeutic alternatives.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate,

based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and

GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor

immune response.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in

2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s

proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic

anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing

of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and

durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment

modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information,

please visit www.replimune.com.

Forward Looking Statements

This press release contains forward looking statements within the meaning

of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including

the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials,

the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory

review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments

in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,”

“expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,”

“would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees

of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could

cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related

to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for

our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals,

the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject,

competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact

of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and

other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports

we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied

by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake

no obligation to update or revise these forward-looking statements.

Investor Inquiries

Chris Brinzey

ICR Healthcare

339.970.2843

chris.brinzey@icrhealthcare.com

Media Inquiries

Arleen Goldenberg

Replimune

917.548.1582

media@replimune.com

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