Stoke Therapeutics: H2 2026'da ön-NDA FDA toplantısı planlandı

The company announced a pre-NDA meeting with the FDA scheduled for H2 2026 to align on the data package and statistical analysis plan ahead of a planned rolling U.S. NDA submission for zorevunersen in Dravet syndrome. The meeting is the next formal regulatory interaction before the rolling NDA begins in Q1 2027.

Temel olgular

Bildirildi: 3 Ağu 2026 20:05
Olay: PDUFA tarihi belirlendi
Yön: Nötr
Şirket: STOKStoke Therapeutics
Varlık: zorevunersen
Kaynak: SEC 8-K
Güvenilirlik: Kaynaklı
Takvim: Danışma komitesi · 1 Tem 2026

Kaynak alıntısı

EX-99.1 2 stok-ex99_1.htm EX-99.1 EX-99.1 EX 99.1 Stoke Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Updates – Phase 3 EMPEROR study of zorevunersen in Dravet syndrome: Enrollment of 162 patients complete with data readout anticipated in Q3 2027– – Pre-NDA meeting with FDA scheduled for H2 2026; rolling U.S. NDA submission planned to initiate in Q1 2027 – – Phase 1 OSPREY study of STK-002 in patients with ADOA: Dosing complete in sentinel cohort; dose escalation continuing and initial data anticipated in H1 2027– – $420M in cash, cash equivalents and marketable securities based on $354.3M as of June 30, 2026 and $65.7M from a subsequent ATM sale; expected to fund operations through to potential U.S. commercialization of zorevunersen in early 202

SEC 8-K