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8-K
false000157942800015794282023-08-042023-08-04

 

 

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): August 04, 2023

 

 

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 August 4, 2023, Axsome Therapeutics, Inc. (the “Company”) received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Hikma Pharmaceuticals USA Inc. (“Hikma”), providing notification to the Company that Hikma has submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use, or sell a generic version of Sunosi® (solriamfetol hydrochloride).

 

In the Notice Letter, Hikma alleges that the following patents listed in the FDA Orange Book for Sunosi are invalid, unenforceable, or will not be infringed by Hikma's manufacture, use, or sale of the generic product described in its ANDA submission: 8,440,715, 10,195,151, 10,512,609, 10,912,754, 10,940,133, 10,959,976, 11,160,779, 11,439,597, 11,560,354, and 11,648,232 (the “PIV Notice Patents”). The last of the PIV Notice Patents expires in 2040.

​Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

 

 

Exhibit No.

 

Description

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 thereunto duly authorized.

 

 

 

Axsome Therapeutics, Inc.

 

 

 

 

Date:

August 4, 2023

By:

/s/ Herriot Tabuteau, M.D.

 

 

Name:

Title:

 

Herriot Tabuteau, M.D.
President and Chief Executive Officer