Welcome to our dedicated page for Avenue Therapeutics SEC filings (Ticker: ATXI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Avenue Therapeutics SEC filings document material agreements, governance actions, and the security status of an OTC-quoted specialty pharmaceutical issuer. Recent Form 8-K reports record the exclusive worldwide Duke University license for ATX-04 patents and know-how, the completed sale of Baergic Bio and BAER-101 rights, annual-meeting voting results, and stockholder proposal and director-nomination procedures.
Proxy materials address board elections, auditor ratification, executive compensation tables, and related corporate-governance disclosures. The filings also identify ATXI common stock as registered under Section 12(g) and quoted on OTC Markets.
Avenue Therapeutics reported a smaller quarterly net loss while continuing to face serious funding pressure. For the quarter ended March 31, 2026, the company lost about $0.7 million, compared with $1.9 million a year earlier, as operating expenses fell sharply.
Cash and cash equivalents were $2.4 million, down from $2.9 million at year-end, and management states there is substantial doubt about Avenue’s ability to continue as a going concern without new financing. The company licensed ATX‑04 from Duke University for Pompe disease and is preparing for a pivotal program, while also evaluating a Phase 3 safety study for IV tramadol that will require additional capital or a partner.
Avenue Therapeutics, Inc. files its annual report describing a neurology-focused specialty pharmaceutical business built around two main programs: ATX-04 for Pompe disease and IV tramadol for post‑operative pain. The company currently has no approved products and depends on these product candidates.
In February 2026, Avenue entered an exclusive worldwide license with Duke University for ATX-04 (clenbuterol) targeting lysosomal storage diseases, initially Pompe disease, leveraging encouraging 52‑week Phase I/II data from Duke. Avenue plans a pre‑IND meeting with the FDA to align on a pivotal trial and then seek capital to fund it.
The report details a long regulatory history for IV tramadol, including two FDA Complete Response Letters and multiple appeals and meetings. In January 2024, Avenue reached final FDA agreement on a Phase 3 non‑inferiority safety study comparing opioid‑induced respiratory depression for IV tramadol versus IV morphine in about 300 post‑bunionectomy patients, but initiation depends on securing financing or a partner.
Avenue also executed strategic portfolio changes. In April 2025 it terminated its AJ201 license with AnnJi, mutually releasing claims and transferring AJ201‑related assets back to AnnJi, with certain small cash flows between the parties. In November 2025, Avenue sold its Baergic Bio subsidiary and BAER‑101 rights to Axsome Therapeutics for upfront cash and potential milestones and royalties, retaining eligibility for about 74% of future Baergic‑related payments.
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. (ATXI) received an amended Schedule 13G filing from Ikarian Capital, LLC and its controller, Neil Shahrestani, reporting passive ownership of Avenue’s common stock. The reporting group beneficially owns 130,820 shares, representing 4.1% of the common stock, based on 3,183,426 shares outstanding as of November 25, 2025.
The shares are held by Ikarian Healthcare Master Fund, L.P. and certain separately managed accounts over which Ikarian Capital has investment discretion. The filing states the holdings are in the ordinary course of business and are not for the purpose of changing or influencing control of Avenue Therapeutics.
Fortress Biotech, Inc. filed Amendment No. 8 to its Schedule 13D for Avenue Therapeutics, Inc., reporting beneficial ownership of 439,955 shares of Avenue common stock, equal to 13.4% of the outstanding common shares. This total includes 250,000 shares of Class A preferred stock, which are convertible into 222 shares of common stock and are structured so that the Class A preferred will at all times constitute a voting majority. Fortress owns all outstanding Class A preferred shares, giving it majority voting control despite a minority economic stake.
Fortress’s ownership also reflects an Annual Equity Grant under a Founders Agreement, through which Avenue issues to Fortress each year shares equal to 2.5% of Avenue’s fully diluted outstanding equity. In addition, as holder of the Class A preferred, Fortress is entitled each January 1 to stock dividends in Avenue common equal to 2.5% of Avenue’s fully diluted outstanding capitalization. The filing notes 296 Avenue common shares underlying outstanding warrants granted by Fortress to two of its executives, with Fortress retaining sole voting power but shared dispositive power over those warrant shares.
Avenue Therapeutics, Inc. reported an insider stock award linked to preferred stock dividends. A reporting person who is both a director and a 10% owner received 111,209 shares of common stock on 01/02/2026 at a price of $0. These shares were granted as the 2025 annual dividend on the holder’s Class A Preferred Stock, which is entitled to a 2.5% annual dividend based on Avenue’s fully diluted outstanding capitalization on December 31. After this grant, the reporting person beneficially owned 439,733 shares of Avenue Therapeutics common stock in direct ownership.
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 is registering 731,061 shares of common stock for resale by existing warrant holders. These shares consist of 689,680 Series C Warrant Shares with a $6.20 exercise price and 41,381 Placement Agent Warrant Shares with a $7.75 exercise price. The company will not receive proceeds from stockholder resales, but would receive cash if the warrants are exercised.
This post-effective amendment moves a prior resale registration from Form S-3 to Form S-1 after Avenue’s common stock was delisted from Nasdaq and began trading on the OTCID Market under the symbol “ATXI.” On December 11, 2025, 3,183,558 shares of common stock were outstanding; this is a baseline figure, not the amount being offered.
Avenue is a specialty pharmaceutical company developing intravenous tramadol for post-operative acute pain, with a Phase 3 safety study protocol and statistical plan agreed with the FDA, and study initiation dependent on additional financing or a partnership. In November 2025 it sold subsidiary Baergic Bio, transferring epilepsy candidate BAER-101 to Axsome Therapeutics for a $0.3 million upfront payment plus contingent milestones and royalties, and in April 2025 it terminated its AnnJi AJ201 license in exchange for $2.0 million in scheduled payments while returning product rights to AnnJi.