zorevunersen — FDA meeting
H2 2026
– Pre-NDA meeting with FDA scheduled for H2 2026; rolling U.S. NDA submission planned to initiate in Q1 2027 –Source filing
STOK biotech catalysts & pipeline
STOKE THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
STK-002 — Topline data
H1 2027
Subject to ongoing safety assessments, dosing in the third and fourth dose cohorts are expected to follow with a readout of safety and efficacy results anticipated in the first half of 2027.Source filing
zorevunersen — NDA/BLA submission
Q1 2027
– Pre-NDA meeting with FDA scheduled for H2 2026; rolling U.S. NDA submission planned to initiate in Q1 2027 –Source filing
zorevunersen — Topline data
Q3 2027
A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the planned rolling U.S. NDA submission in the second half of 2027.Source filing
zorevunersen — NDA/BLA submission
late 2027
Commercial preparation is underway to support a potential U.S. commercial launch as early as late 2027.Source filing