Registro de fuente primaria
MaterialFecha PDUFA fijada
Eton: la NDA de ET-600 fue aceptada; PDUFA fijada para el 25 de febrero de 2026
FDA accepted the ET-600 NDA for review and assigned a PDUFA target action date of February 25, 2026. The company has begun launch-preparation activities, including production of launch inventory in Q4 2025, targeting a potential first-quarter 2026 commercial launch.
Datos clave
- Presentado
- 6 nov 2025, 21:25
- Evento
- Fecha PDUFA fijada
- Dirección
- Neutral
- Empresa
ETONEton Pharmaceuticals- Activo
- ET-600
- Fuente
- SEC 8-K
- Confianza
- Con fuente
- Calendario
- Decisión de la FDA (PDUFA) · 25 feb 2026 · Resultado no registrado
Extracto de la fuente
EX-99.1 2 ex_854696.htm EXHIBIT 99.1 ex_854696.htm Exhibit 99.1 Eton Pharmaceuticals Reports Third Quarter 2025 Financial Results ● Q3 2025 product sales of $22.5 million, representing 129% growth over Q3 2024 and the 19th straight quarter of sequential product sales growth ● Q3 2025 basic and fully diluted GAAP EPS of $(0.07), non-GAAP fully diluted EPS of $0.04, and Adjusted EBITDA of $2.9 million ● ET-600 NDA accepted for review, assigned PDUFA date of February 25, 2026 ● GALZIN® launch ahead of plan; exceeded previous year-end target of 200 active patients ● Held positive FDA meeting clarifying pathway to KHINDIVI™ label expansion ● Submitted proposed clinical study to support INCRELEX® label expansion ● Generated $12.0 million of cash from operations in the quarter ●