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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">CURRENT REPORT</span></p>
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:9pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Securities registered pursuant to Section 12(b) of the Act:</span></p>
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  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8239;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;&#8239;240.12b-2 of this chapter).</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:2.25pt double #000000;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;min-height:0.5in;justify-content:flex-end;"></div>
  <hr style="page-break-after:always;"/>
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  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 8.01 Other Events.</span></p>
  <p style="text-indent:6.667%;font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On June 5, 2024, Axsome Therapeutics, Inc. (the &#8220;Company&#8221;) issued a press release announcing that it has entered into a settlement agreement with Unichem Laboratories Ltd. (&#8220;Unichem&#8221;) resolving patent litigation related to the Company&#8217;s product, Sunosi&#174; (solriamfetol) (&#8220;SUNOSI&#8221;).  The litigation, which is pending in the U.S. District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of SUNOSI in the United States.  The settlement agreement permits Unichem to begin selling its generic version of SUNOSI on June 30, 2042, or earlier under certain circumstances.  The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.</span></p>
  <p style="text-indent:6.667%;font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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. Similar patent litigation brought by Axsome against other parties remains pending in the U.S. District Court for the District of New Jersey.</span></p>
  <p style="text-indent:6.667%;font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.</span></p>
  <p style="font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 9.01 Financial Statements and Exhibits.</span></p>
  <p style="margin-left:6.667%;font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">(d) Exhibits</span></p>
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    <td style="vertical-align:bottom;border-bottom:1pt solid #ffffff03;text-align:left;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;"> </span></p></td>
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    <td style="vertical-align:top;"><p style="font-size:2pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
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    <td style="vertical-align:bottom;"><p style="font-size:1pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;min-height:0.5in;justify-content:flex-end;"></div>
  <hr style="page-break-after:always;"/>
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  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">SIGNATURES</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span></p>
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    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Date:</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">June 5, 2024</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">By:</span><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">/s/ Herriot Tabuteau, M.D.</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Name:</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Title:</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0.7pt;font-family:Times New Roman;margin-bottom:9.35pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Herriot Tabuteau, M.D. <br/>President and Chief Executive Officer</span></p></td>
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8-K
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 05, 2024
Axsome Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-37635
45-4241907
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
One World Trade Center, 22nd Floor
New York
,
New York
10007
(Address of Principal Executive Offices)
(Zip Code)
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:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, Par Value $0.0001 Per Share
AXSM
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 June 5, 2024, Axsome Therapeutics, Inc. (the "Company") issued a press release announcing that it has entered into a settlement agreement with Unichem Laboratories Ltd. ("Unichem") resolving patent litigation related to the Company's product, Sunosi® (solriamfetol) ("SUNOSI").  The litigation, which is pending in the U.S. District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of SUNOSI in the United States.  The settlement agreement permits Unichem to begin selling its generic version of SUNOSI on June 30, 2042, or earlier under certain circumstances.  The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.
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. Similar patent litigation brought by Axsome against other parties remains pending in the U.S. District Court for the District of New Jersey.
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
Exhibit No.
Description
99.1
Press Release dated June 5, 2024.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
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.
Axsome Therapeutics, Inc.
Date:
June 5, 2024
By:
/s/ Herriot Tabuteau, M.D.
Name:
Title:
Herriot Tabuteau, M.D.
President and Chief Executive Officer