secwatch.observer — SEC 8-K summary
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Issuer:     Eton Pharmaceuticals, Inc. (ETON)
CIK:        0001710340
Form:       8-K
Filed at:   2026-07-29T11:00:14+00:00
Accession:  0001437749-26-024746
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Eton submits PAS to expand KHINDIVI indication to younger pediatric patients
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710340/000143774926024746/0001437749-26-024746-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710340/000143774926024746/eton20260723_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-024746

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer