一次情報の記録
重要PDUFA 日設定
Eton ET-600 NDA受理; PDUFAがFebruary 25, 2026に設定
FDAはET-600 NDAの審査を受理し、PDUFA target action dateをFebruary 25, 2026に割り当てました。会社はQ4 2025におけるlaunch inventoryの生産を含むlaunch-preparation activitiesを開始し、potential first-quarter 2026 commercial launchを目標としています。
主要事実
出典の抜粋
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 ●