---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-024746"
form_type: "8-K"
ticker: "ETON"
cik: "0001710340"
company_name: "Eton Pharmaceuticals, Inc."
filed_at: "2026-07-29T11:00:14+00:00"
generated_at: "2026-07-29T11:06:36.283598+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Eton submits PAS to expand KHINDIVI indication to younger pediatric patients

## Summary
- Submitted Prior Approval Supplement to FDA to expand KHINDIVI label to include children under age 5.
- New formulation demonstrated bioequivalence to ALKINDI SPRINKLE oral granules.
- Potential expanded indication approval expected in first half 2027.
- KHINDIVI is the only FDA-approved oral solution of hydrocortisone; currently approved for ages 5+.
- CEO estimates ~10,000 pediatric adrenal insufficiency patients in the U.S.

## SEC filing metadata
- accession: 0001437749-26-024746
- form_type: 8-K
- ticker: ETON
- cik: 0001710340
- company_name: Eton Pharmaceuticals, Inc.
- filed_at: 2026-07-29T11:00:14+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710340/000143774926024746/0001437749-26-024746-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710340/000143774926024746/eton20260723_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-024746
- JSON: https://secwatch.observer/filing/0001437749-26-024746.json
- Plain text: https://secwatch.observer/filing/0001437749-26-024746.txt

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