1차 출처 기록
중대신청 접수
Regeneron: FDA, cemdisiran NDA 수락 및 gMG 대상 2026년 11월 PDUFA 설정
FDA와 EMA가 성인 gMG 대상 cemdisiran의 규제 서류를 수락했습니다. FDA는 우선 심사권을 부여했으며 2026년 11월 목표 조치일을 설정했습니다. EC 결정은 2027년 하반기로 예상됩니다.
핵심 사실
출처 발췌
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