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
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Date of Report (Date of earliest event reported): May 27, 2025 |
Axsome Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-37635 |
45-4241907 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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One World Trade Center, 29th Floor |
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New York, New York |
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10007 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: (212) 332-3241 |
(Former Name or Former Address, if Changed Since Last Report)
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:
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Title of each class
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Trading
Symbol(s) |
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Name of each exchange on which registered
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Common Stock, Par Value $0.0001 Per Share |
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AXSM |
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Nasdaq Global 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 8.01 Other Events.
On May 27, 2025, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hetero of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Hetero a license to sell its generic version of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. Similar patent litigation brought by Axsome against other parties related to SUNOSI remains pending in the U.S. District Court for the District of New Jersey.
The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The description of the settlement agreement contained herein does not purport to be complete.
The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Axsome Therapeutics, Inc. |
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Date: |
May 27, 2025 |
By: |
/s/ Herriot Tabuteau, M.D. |
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Name: Title: |
Herriot Tabuteau, M.D.
President and Chief Executive Officer |