Catatan sumber primer
MaterialPermohonan diterima
Regeneron: FDA menerima NDA cemdisiran untuk gMG, menetapkan PDUFA Nov 2026
FDA dan EMA menerima pengajuan regulasi untuk cemdisiran pada gMG dewasa. FDA memberikan tinjauan prioritas dengan tanggal tindakan target November 2026; keputusan EC diharapkan H2 2027.
Fakta utama
- Diajukan
- 30 Jul 2026, 10.48
- Peristiwa
- Permohonan diterima
- Arah
- Netral
- Perusahaan
REGNRegeneron- Aset
- cemdisiran
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 1 Nov 2026
Kutipan sumber
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