other material
confidence high
sentiment positive
materiality 0.72
ET-600 passes pivotal bioequivalence study; NDA submission expected April 2025
Eton Pharmaceuticals, Inc.
- ET-600 (desmopressin oral solution) met primary endpoint in pivotal bioequivalence study of 75 healthy subjects.
- Company expects to submit NDA to FDA in April 2025; if approved, would be only FDA-approved oral liquid desmopressin.
- CEO Brynjelsen anticipates potential product launch in Q1 2026; pre-launch commercial activities underway.
- ET-600 is a proprietary patented formulation for central diabetes insipidus targeting precise pediatric dosing.