---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-045628"
form_type: "8-K"
ticker: "ATOS"
cik: "0001488039"
company_name: "ATOSSA THERAPEUTICS, INC."
filed_at: "2026-02-11T23:59:59+00:00"
generated_at: "2026-05-16T03:17:17.148237+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Atossa receives FDA Rare Pediatric and Orphan Drug designations for (Z)-endoxifen in DMD; pauses MBC

## Summary
- FDA Rare Pediatric Disease and Orphan Drug designations granted for (Z)-endoxifen in Duchenne Muscular Dystrophy (Dec 2025/Jan 2026).
- Paused investment in metastatic breast cancer (MBC) to prioritize other oncology and rare disease programs.
- Cash and equivalents >$40M as of early 2026, supporting >1 year of working capital.
- Reverse stock split effective Feb 2, 2026 to regain Nasdaq listing compliance.
- I-SPY 2 combination therapy enrollment near complete; preliminary data expected H2 2026.

## SEC filing metadata
- accession: 0001193125-26-045628
- form_type: 8-K
- ticker: ATOS
- cik: 0001488039
- company_name: ATOSSA THERAPEUTICS, INC.
- filed_at: 2026-02-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1488039/000119312526045628/0001193125-26-045628-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1488039/000119312526045628/atos-20260211.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-045628
- JSON: https://secwatch.observer/filing/0001193125-26-045628.json
- Plain text: https://secwatch.observer/filing/0001193125-26-045628.txt

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