Axsome Therapeutics Files 8-K Report

TL;DR

AXSM filed an 8-K on Feb 10, 2025 - check for updates.

AI Summary

On February 10, 2025, Axsome Therapeutics, Inc. filed an 8-K report. The filing primarily concerns "Other Events" and "Financial Statements and Exhibits," indicating updates or disclosures related to the company's financial status and significant business occurrences. No specific financial figures or new events were detailed in the provided excerpt.

Why It Matters

This filing signals an update from Axsome Therapeutics to the SEC, potentially containing material information for investors regarding the company's operations or financial standing.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report with no immediate indication of significant negative events or financial distress.

Key Players & Entities

• Axsome Therapeutics, Inc. (company) — Registrant
• February 10, 2025 (date) — Date of earliest event reported
• 001-37635 (other) — Commission File Number
• 45-4241907 (other) — IRS Employer Identification No.
• One World Trade Center, 22nd Floor (location) — Principal Executive Offices Address
• New York (location) — Principal Executive Offices City
• 10007 (other) — Principal Executive Offices Zip Code
• (212) 332-3241 (phone_number) — Registrant's Telephone Number

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, Par Value $0.0001 Per Share AXSM Nasdaq Global Market

Filing Documents

• axsm-20250210.htm (8-K) — 45KB
• axsm-ex99_1.htm (EX-99.1) — 19KB
• img36028404_0.jpg (GRAPHIC) — 65KB
• 0000950170-25-016678.txt ( ) — 266KB
• axsm-20250210.xsd (EX-101.SCH) — 23KB
• axsm-20250210_htm.xml (XML) — 4KB

01 Other Events

Item 8.01 Other Events. On February 10, 2025, Axsome Therapeutics, Inc. (the "Company") issued a press release announcing that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome's AUVELITY (dextromethorphan HBr– bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of AUVELITY in the United States prior to the expiration of applicable Axsome patents. Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after March 31, 2039 if pediatric exclusivity is granted for AUVELITY, or on or after September 30, 2038 if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the U.S. District Court for the District of New Jersey. The settlement agreement resolves all outstanding patent litigation relating to AUVELITY. 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.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated February 10, 2025. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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: February 10, 2025 By: /s/ Herriot Tabuteau, M.D. Name: Title: Herriot Tabuteau, M.D. President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR