---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-002935"
form_type: "8-K"
ticker: "ETON"
cik: "0001710340"
company_name: "Eton Pharmaceuticals, Inc."
filed_at: "2025-02-06T23:59:59+00:00"
generated_at: "2026-05-27T01:42:25.040427+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for Eton's ET-400 NDA to May 28, 2025

## Summary
- Original PDUFA date Feb 28, 2025 extended 3 months to May 28, 2025 for FDA review of supplemental info submitted Dec 2024.
- Eton states it has fully addressed all FDA questions and there are no outstanding requests.
- CEO says standard extension will not significantly affect internal 2025 revenue projections; company remains confident.

## SEC filing metadata
- accession: 0001437749-25-002935
- form_type: 8-K
- ticker: ETON
- cik: 0001710340
- company_name: Eton Pharmaceuticals, Inc.
- filed_at: 2025-02-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710340/000143774925002935/0001437749-25-002935-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710340/000143774925002935/eton20250205_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-002935
- JSON: https://secwatch.observer/filing/0001437749-25-002935.json
- Plain text: https://secwatch.observer/filing/0001437749-25-002935.txt

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