Here are the 10-K annual reports from Avenue Therapeutics Inc (ATXI) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, 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. 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.