Regeneron：FDA 受理 cemdisiran 用於 gMG 之 NDA，設定 2026 年 11 月 PDUFA

FDA 與 EMA 已受理 cemdisiran 用於成人 gMG 之法規申請。FDA 授予優先審查，目標行動日期為 2026 年 11 月；EC 預計於 2027 年下半年作出決定。

關鍵事實

申報時間: 2026年7月30日上午10:48
事件: 申請已受理
方向: 中性
公司: REGN再生元製藥
資產: cemdisiran
來源: SEC 8-K
可信度: 有出處
行事曆: FDA 審查決定 (PDUFA) · 2026年11月1日

來源摘錄

EX-99.1 2 exhibit991q22026.htm EXHIBIT 99.1 Document Exhibit 99.1 Press Release Regeneron Reports Second Quarter 2026 Financial and Operating Results • Second quarter 2026 revenues increased 17% to $4.3 billion versus second quarter 2025 • Dupixent ® global net sales (recorded by Sanofi) increased 38% to a new all-time high of $6.0 billion • EYLEA HD ® U.S. net sales increased 52% to a new all-time high of $596 million • Libtayo ® global net sales increased 30% to a new all-time high of $489 million • GAAP EPS of $12.23, including $1.02 negative impact from IPR&D; non-GAAP EPS (a) of $14.29, including $0.99 negative impact from IPR&D • Sanofi Development Balance fully repaid as of end of second quarter 2026 • Cemdisiran regulatory submissions accepted for review by FDA and EMA for trea

SEC 8-K