原始来源记录
重大申请已受理
Regeneron：FDA接受cemdisiran用于gMG的NDA，设定2026年11月PDUFA
FDA和EMA已接受cemdisiran用于成人gMG的监管申报。FDA授予优先审评，目标行动日期为2026年11月；EC预计于2027年下半年作出决定。
关键事实
- 申报时间
- 2026年7月30日 10:48
- 事件
- 申请已受理
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年11月1日
来源摘录
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