secwatch.observer — SEC 8-K summary
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Issuer:     Eton Pharmaceuticals, Inc. (ETON)
CIK:        0001710340
Form:       8-K
Filed at:   2024-07-15T23:59:59+00:00
Accession:  0001437749-24-022736
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025
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- PDUFA target action date set for February 28, 2025.
- ET-400 is a proprietary room-temperature stable hydrocortisone oral solution with patent protection through 2043.
- CEO Sean Brynjelsen projects combined peak sales of ET-400 and ALKINDI SPRINKLE to exceed $50 million annually.
- Company preparing for potential product launch in early 2025 upon FDA approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/0001437749-24-022736-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/eton20240708_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-022736

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