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荷尔蒙失调疗法接受FDA审查，伊顿公学股价上涨
2025-07-08 19:33
- Shares of Eton Pharmaceuticals (NASDAQ:ETON) added ~8% in the premarket on Tuesday after the FDA agreed to review its marketing application for ET-600, a potential treatment for a rare hormonal disorder known as central diabetes insipidus.
- Also known as arginine vasopressin deficiency (AVP-D), central diabetes insipidus is estimated to affect nearly 3,000 U.S. children.
- Eton’s (NASDAQ:ETON) New Drug Application (NDA), targeting the U.S. approval of a formulation of desmopressin oral solution, has been accepted by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026, the company said.
- “ET-600 represents yet another high-value near-term product launch opportunity for Eton,” CEO Sean Brynjelsen remarked, adding that the company has started initial activities to launch ET-600 in Q1 2026.
More on Eton Pharmaceuticals
- Eton Pharmaceuticals: Rapid Revenue Growth And Pipeline Catalysts Point To More Upside
- Eton Pharmaceuticals Set To Dominate Orphan Drug Niche
- Eton Pharmaceuticals, Inc. (ETON) Q1 2025 Earnings Call Transcript
- Eton Pharma wins FDA nod for oral hydrocortisone solution
- Eton outlines path to $100M near-term revenue with ET-400 launch and Increlex growth
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