Stoke Therapeutics: naitakda na ang pre-NDA FDA meeting para sa H2 2026

Inihayag ng kumpanya ang isang pre-NDA meeting sa FDA na naka-iskedyul para sa H2 2026 upang i-align ang data package at statistical analysis plan bago ang nakaplanong rolling U.S. NDA submission para sa zorevunersen sa Dravet syndrome. Ang meeting ay ang susunod na pormal na regulatory interaction bago magsimula ang rolling NDA sa Q1 2027.

Mahahalagang fact

Na-file: Ago 3, 2026, 08:05 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: STOKStoke Therapeutics
Asset: zorevunersen
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Advisory committee · Hul 1, 2026

Sipi mula sa source

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