---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-113371"
form_type: "8-K"
ticker: "ATOS"
cik: "0001488039"
company_name: "ATOSSA THERAPEUTICS, INC."
filed_at: "2025-09-08T23:59:59+00:00"
generated_at: "2026-05-17T07:32:48.665566+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Atossa requests FDA Type C meeting to accelerate low-dose (Z)-endoxifen for breast cancer risk reduction

## Summary
- Company requested a Type C FDA meeting; expects update by year-end 2025.
- Favorable outcome could shorten approval timeline by years and avoid tens of millions in trial costs.
- Cash position of $57.9M with no debt as of June 30, 2025; potential multi-billion-dollar market highlighted.
- Annual U.S. tamoxifen prescriptions estimated at 1.6-2.1 million; 4.3M women live with breast cancer history.
- (Z)-endoxifen avoids CYP2D6 metabolism issues affecting ~20% of tamoxifen patients.

## SEC filing metadata
- accession: 0000950170-25-113371
- form_type: 8-K
- ticker: ATOS
- cik: 0001488039
- company_name: ATOSSA THERAPEUTICS, INC.
- filed_at: 2025-09-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1488039/000095017025113371/0000950170-25-113371-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1488039/000095017025113371/atos-20250908.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-113371
- JSON: https://secwatch.observer/filing/0000950170-25-113371.json
- Plain text: https://secwatch.observer/filing/0000950170-25-113371.txt

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