Avenue Therapeutics licenses ATX-04 from Duke University for Pompe disease; plans late-stage development

AVENUE THERAPEUTICS, INC.

Exclusive worldwide license from Duke for ATX-04 (clenbuterol) to treat Pompe disease as adjunct to ERT.
Upfront payment plus development, regulatory, and commercial milestone payments; tiered low single-digit royalty on net sales.
Prior Duke clinical study showed ATX-04 improved six-minute walk distance, respiratory muscle strength, and reduced glycogen.
Avenue to assume IND and FDA orphan drug designation for Pompe disease; plans late-stage development leveraging existing data.

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Key facts

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Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

AVENUE THERAPEUTICS, INC. entered into License Agreement with Duke University (effective 2026-02-18).

Action: entry
Agreement: license
Counterparty: Duke University
Effective: 2026-02-18

Exact text from the filing

On February 18, 2026, Avenue Therapeutics, Inc. (the “Company”) entered into a license agreement (the “License Agreement”) with Duke University (“Duke”), whereby the Company obtained from Duke an exclusive, worldwide license to certain patents and know-how

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Source: SEC EDGAR

accession 0001104659-26-018582

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