← Catalyst calendarSTOK biotech catalysts & pipeline
STOKE THERAPEUTICS INC · Data as of 2026-10-25
Upcoming catalysts
zorevunersen — FDA meeting
H2 2026
In August 2026, we announced that Stoke intends to participate in a pre-NDA meeting with the FDA during the second half of 2026 in preparation for the rolling NDA submission planned to initiate in the first quarter of 2027.
Source filingSTK-002 — Initial data
H1 2027
Initial safety and efficacy results are anticipated in the first half of 2027.
Source filingzorevunersen — Clinical data readout
Q3 2027
The Company plans to continue actively engaging with the FDA and to submit data throughout the first half of 2027 to support rapid completion of the NDA submission following the Phase 3 readout anticipated in the third quarter of 2027.
Source filingzorevunersen — NDA/BLA submission
late 2027
Commercial preparation is underway to support a potential U.S. commercial launch as early as late 2027.
Source filingExplore the free biotech catalyst calendar