Catatan sumber primer
MaterialPermohonan diterima
Incyte: FDA menerima NDA untuk povorcitinib pada hidradenitis suppurativa
FDA menerima NDA Incyte untuk povorcitinib pada hidradenitis suppurativa sedang hingga berat pada Q1 2026. Penerimaan ini memicu jam tinjauan standar dengan potensi persetujuan dan peluncuran di AS yang kini dipandu ke Q1 2027. Pengajuan ini merupakan salah satu dari empat persetujuan yang diantisipasi perusahaan antara pertengahan 2026 dan awal 2027.
Fakta utama
- Diajukan
- 28 Apr 2026, 11.03
- Peristiwa
- Permohonan diterima
- Arah
- Positif
- Perusahaan
INCYIncyte- Aset
- povorcitinib
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 incy-q12026xexx991.htm EX-99.1 Document Exhibit 99.1 FOR IMMEDIATE RELEASE Incyte Reports First Quarter 2026 Financial Results and Provides Business Updates Total revenue of $1.27 billion and total net sales of $1.10 billion in the first quarter of 2026, an increase of 21% and 20% respectively, compared to the first quarter of 2025 Jakafi ® (ruxolitinib) net sales of $758 million, an increase of 7% compared to the same period in 2025 Opzelura ® (ruxolitinib) cream net sales of $143 million and Hematology and Oncology portfolio net sales of $204 million, an increase of 20% and 116%, respectively, compared to the first quarter of 2025 Four anticipated approvals and launches from mid-2026 into early 2027 Advanced povorcitinib development program, including the New Drug Applicati