Celcuity: FDA menerima NDA, memberikan Tinjauan Prioritas untuk gedatolisib

FDA menerima NDA untuk gedatolisib dan memberikan Tinjauan Prioritas dengan tanggal target PDUFA pada 17 Juli 2026. Pengajuan ini mencakup kohort PIK3CA wild-type dari studi Fase 3 VIKTORIA-1 pada kanker payudara lanjut HR+/HER2-. Hal ini menetapkan garis waktu regulasi yang jelas untuk potensi persetujuan pada kuartal ketiga 2026.

Fakta utama

Diajukan: 25 Mar 2026, 20.10
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: CELCCelcuity
Aset: gedatolisib
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 17 Jul 2026 · Positif

Kutipan sumber

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update – The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type (“WT”) advanced breast cancer (“ABC”) – Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical Oncology – Topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected to be released in the second quarter of 2026 – Management to host webcast and conference call today, March 25, 2026,

SEC 8-K