Record mula sa primary source
MateryalTinanggap ang aplikasyon
Regeneron: Tinanggap ng FDA ang NDA ng cemdisiran para sa gMG, itinakda ang Nov 2026 PDUFA
Tinanggap ng FDA at EMA ang mga regulatory filing para sa cemdisiran sa adult gMG. Nagbigay ang FDA ng priority review na may target action date na Nobyembre 2026; inaasahan ang desisyon ng EC sa H2 2027.
Mahahalagang fact
- Na-file
- Hul 30, 2026, 10:48 AM
- Kaganapan
- Tinanggap ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
REGNRegeneron- Asset
- cemdisiran
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Nob 1, 2026
Sipi mula sa source
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