Apotex targets Axsome (AXSM) Symbravo with Paragraph IV generic bid

Rhea-AI Filing Summary

Axsome Therapeutics reports that Apotex has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market a generic version of Symbravo, a meloxicam‑rizatriptan benzoate product. Axsome received a Paragraph IV certification notice from Apotex, which is a formal notification tied to generic drug applications. The company states that it plans to respond to this notice in due course, indicating the start of a potential patent and exclusivity challenge to Symbravo.

Insights

Biopharma IP and regulatory analyst

Axsome faces a Paragraph IV challenge to Symbravo from Apotex.

Axsome Therapeutics has received a Paragraph IV certification notice from Apotex, which has filed an ANDA with the FDA to market a generic version of Symbravo (meloxicam‑rizatriptan benzoate). In U.S. generics law, a Paragraph IV notice is a standard step when generics seek to enter a branded drug’s market before or around patent expiry.

This development signals an intent by Apotex to introduce a lower‑cost generic that would compete directly with Symbravo once allowed. The text does not describe any lawsuit or settlement, only that Axsome expects to respond to the notice, which is typically the first step in protecting intellectual property and market position.

Future disclosures in company communications may clarify whether Axsome initiates patent litigation, any potential stay of FDA approval, and how long Symbravo could remain free from generic competition if existing protections are upheld.

false000157942800015794282025-08-192025-08-19

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 19, 2025

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, 29th 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 19, 2025, Axsome Therapeutics, Inc. (the “Company”) received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Apotex Inc. (“Apotex”), providing notification to the Company that Apotex 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 Symbravo® (meloxicam-rizatriptan benzoate). The Company anticipates responding to the Notice Letter in due course.

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 hereunto duly authorized.

			Axsome Therapeutics, Inc.
Date:	August 20, 2025	By:	/s/ Herriot Tabuteau, M.D.
		Name: Title:	Herriot Tabuteau, M.D. President and Chief Executive Officer

FAQ

What event did Axsome Therapeutics (AXSM) disclose regarding Symbravo?

Axsome disclosed that it received a Paragraph IV Certification Notice from Apotex, which filed an ANDA with the FDA seeking approval to market a generic version of Symbravo (meloxicam‑rizatriptan benzoate).

Who is seeking to market a generic version of Symbravo from Axsome Therapeutics (AXSM)?

Generic drug maker Apotex Inc. has submitted an Abbreviated New Drug Application to the FDA to manufacture, use, or sell a generic version of Symbravo.

What is a Paragraph IV Certification Notice in the context of Axsome Therapeutics (AXSM)?

A Paragraph IV Certification Notice informs the brand‑name company that a generic company has filed an ANDA asserting it can seek approval to market a generic version, here referring to Symbravo by Apotex.

How does Axsome Therapeutics (AXSM) plan to respond to Apotex’s ANDA for generic Symbravo?

Axsome states that it anticipates responding to the Notice Letter in due course, indicating it is evaluating its options following Apotex’s ANDA for generic Symbravo.

Does the Axsome Therapeutics (AXSM) update mention financial figures or settlement terms?

No financial figures, settlement terms, or revenue impacts are described; the update focuses on Apotex’s ANDA filing for a generic Symbravo and Axsome’s intention to respond.