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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 |
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
