---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-018582"
form_type: "8-K"
ticker: "ATXI"
cik: "0001644963"
company_name: "AVENUE THERAPEUTICS, INC."
filed_at: "2026-02-23T23:59:59+00:00"
generated_at: "2026-05-16T01:10:57.212755+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-26-018582
- form_type: 8-K
- ticker: ATXI
- cik: 0001644963
- company_name: AVENUE THERAPEUTICS, INC.
- filed_at: 2026-02-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- confidence: high
- sec_items: 1.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1644963/000110465926018582/0001104659-26-018582-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1644963/000110465926018582/tm267053d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-018582
- JSON: https://secwatch.observer/filing/0001104659-26-018582.json
- Plain text: https://secwatch.observer/filing/0001104659-26-018582.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.