Catatan sumber primer
PenentuTanggal PDUFA ditetapkan
Summit Therapeutics: BLA diajukan untuk ivonescimab; PDUFA ditetapkan 14 Nov 2026
Perusahaan mengumumkan bahwa BLA untuk ivonescimab telah diajukan ke FDA. Tanggal target tindakan PDUFA 14 November 2026 telah ditetapkan. Ini menetapkan timeline tinjauan FDA formal pertama untuk aset tersebut di luar China.
Fakta utama
- Diajukan
- 23 Feb 2026, 21.07
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
SMMTSummit Therapeutics- Aset
- ivonescimab
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 14 Nov 2026
Kutipan sumber
EX-99.2 3 a20260223q4fy2025earning.htm EX-99.2 a20260223q4fy2025earning Summit Therapeutics Q4 & FY 2025 Earnings Call February 23, 2026 4:30pm ET Forward Looking Statement Any statements in this presentation about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing a
Selengkapnya tentang aset ini
23 Okt 2026
20.37
SMMTSummit Therapeutics22 Okt 2026
10.00
SMMTSummit TherapeuticsSummit Therapeutics akan Menyajikan Data Ivonescimab di 10 Abstrak pada ESMO 2026
21 Okt 2026
20.42
SMMTSummit Therapeutics19 Okt 2026
11.00
SMMTSummit TherapeuticsSummit Therapeutics membuka uji coba Fase II SMT112-216 regimen ivonescimab pada 1L ccRCC lanjut
5 Okt 2026
11.00
SMMTSummit Therapeutics