Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
Cogent: FDA tetapkan PDUFA 30 Des 2026 untuk NDA bezuclastinib NonAdvSM
FDA menerima NDA bezuclastinib untuk NonAdvanced Systemic Mastocytosis dan menetapkan tanggal tindakan target PDUFA pada 30 Desember 2026. Pengajuan dilakukan di bawah program Real-Time Oncology Review. NDA terpisah untuk GIST juga diajukan di bawah RTOR, dengan NDA ketiga untuk AdvSM direncanakan pada H1 2026.
Fakta utama
- Diajukan
- 5 Mei 2026, 12.08
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
COGTCogent- Aset
- bezuclastinib
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 30 Nov 2026 · Positif
Kutipan sumber
EX-99.1 2 cogt-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results - Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., May 5, 2026 – Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “2026 is shaping up to be a p