---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-018698"
form_type: "8-K"
ticker: "ETON"
cik: "0001710340"
company_name: "Eton Pharmaceuticals, Inc."
filed_at: "2025-05-28T23:59:59+00:00"
generated_at: "2026-05-20T08:19:42.186591+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Eton Pharma gets FDA approval for KHINDIVI oral solution; peak sales >$50M

## Summary
- KHINDIVI is the first and only FDA-approved hydrocortisone oral solution for pediatric adrenocortical insufficiency.
- Commercial launch expected week of June 2, 2025; product distributed through Anovo specialty pharmacy.
- Combined peak sales of KHINDIVI and ALKINDI SPRINKLE expected to exceed $50 million per year.
- Indicated for patients 5 years and older; eliminates need to split or crush tablets for accurate dosing.
- Eton's rare disease sales team to promote alongside ALKINDI SPRINKLE; Eton Cares program offers $0 co-pay for qualifying patients.

## SEC filing metadata
- accession: 0001437749-25-018698
- form_type: 8-K
- ticker: ETON
- cik: 0001710340
- company_name: Eton Pharmaceuticals, Inc.
- filed_at: 2025-05-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710340/000143774925018698/0001437749-25-018698-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710340/000143774925018698/eton20250522_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-018698
- JSON: https://secwatch.observer/filing/0001437749-25-018698.json
- Plain text: https://secwatch.observer/filing/0001437749-25-018698.txt

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