Every 8-K that AVENUE THERAPEUTICS INC (ATXI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ATXI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ATXI filings page.
Avenue Therapeutics, Inc. entered an exclusive worldwide license agreement with Duke University for patents and know‑how covering ATX-04 (clenbuterol), a β2-adrenergic agonist in clinical development for Pompe disease. Avenue will make an upfront payment, reimburse certain patent costs, and pay development, regulatory and commercial milestones plus tiered low single-digit royalties on future net sales.
ATX-04 has human proof-of-concept data from a Duke study in Pompe patients on enzyme replacement therapy (ERT), showing improvements in six-minute walk distance, respiratory muscle strength, reduced muscle glycogen, increased GAA activity and broader gene-expression benefits, and was generally well tolerated. Avenue plans a late-stage clinical program, initially as an adjunct to ERT, and will assume Duke’s existing clinical and regulatory assets, including the IND and FDA orphan drug designation, with potential expansion into other neuromuscular indications.
Avenue Therapeutics, Inc. reported the results of its 2025 annual meeting of stockholders held virtually on December 30, 2025. Stockholders elected six directors to serve until the 2026 annual meeting and ratified the appointment of KPMG LLP as the company’s independent registered public accounting firm for the year ending December 31, 2025.
As of the November 25, 2025 record date, 3,183,426 shares of common stock and 250,000 shares of Class A preferred stock were outstanding and entitled to vote, representing 3,183,426 and 3,500,000 votes, respectively. Each director nominee received between 3,861,558 and 3,862,060 votes in favor, with just over 100,000 votes withheld and no broker non-votes. The auditor ratification received 3,862,335 votes for, 104,651 against, and 1,010 abstentions, indicating strong support from voting stockholders.
Avenue Therapeutics, Inc. has scheduled its 2025 annual meeting of stockholders for December 30, 2025. The exact time and location will be provided in the company’s definitive proxy statement on Schedule 14A to be filed with the SEC.
Stockholders who want their proposals included in the proxy statement under SEC Rule 14a-8 must ensure the company receives them by November 28, 2025 and that they meet all requirements of the Exchange Act and the company’s Second Amended and Restated Bylaws. Proposals or director nominations submitted outside Rule 14a-8, including those using universal proxy rules to solicit support for alternate director nominees, also require written notice to the Corporate Secretary by November 28, 2025 at the company’s Florida headquarters address.
Avenue Therapeutics entered a definitive agreement to sell 100% of its majority‑owned subsidiary Baergic Bio to Axsome Therapeutics for an upfront payment of $0.3 million (less transaction fees), plus contingent consideration. Axsome also obtained worldwide commercial, development, and manufacturing rights to BAER‑101, now referred to as AXS‑17, including all available nonclinical and clinical data.
Former Baergic stockholders, including Avenue, are eligible for up to $2.5 million in development and regulatory milestones for the first indication of AXS‑17 and $1.5 million for each additional indication; up to $79 million in commercial sales milestones; and a tiered mid‑to‑high single‑digit royalty on potential global net sales. Avenue expects to receive approximately 74% of all future payments and royalties under the agreement.
In connection with the disposition, Baergic approved equity awards that vest at closing: 443,578 restricted shares to CEO Alexandra MacLean, M.D. and 266,147 restricted shares to CFO/COO David Jin, entitling them to a portion of future payments and royalties tied to the agreement.