regulatory
confidence high
sentiment neutral
materiality 0.55
FDA extends PDUFA date for Eton's ET-400 NDA to May 28, 2025
Eton Pharmaceuticals, Inc.
- Original PDUFA date Feb 28, 2025 extended 3 months to May 28, 2025 for FDA review of supplemental info submitted Dec 2024.
- Eton states it has fully addressed all FDA questions and there are no outstanding requests.
- CEO says standard extension will not significantly affect internal 2025 revenue projections; company remains confident.