Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
NDA ET-600 Eton diterima; PDUFA ditetapkan pada 25 Februari 2026
FDA menerima NDA ET-600 untuk ditinjau dan menetapkan tanggal tindakan target PDUFA pada 25 Februari 2026. Perusahaan telah memulai kegiatan persiapan peluncuran, termasuk produksi persediaan peluncuran pada Q4 2025, menargetkan peluncuran komersial potensial pada kuartal pertama 2026.
Fakta utama
- Diajukan
- 6 Nov 2025, 21.25
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
ETONEton Pharmaceuticals- Aset
- ET-600
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 25 Feb 2026 · Hasil belum tercatat
Kutipan sumber
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 ●