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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): 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.
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 |
