FDA allows Stoke to administer higher 70mg single dose of STK-001 in Dravet syndrome study

Stoke Therapeutics, Inc.

FDA permits 70mg single dose cohort in Phase 1/2a MONARCH study; dosing expected in coming weeks.
MONARCH remains on partial clinical hold for multiple doses above 45mg; ADMIRAL study continues multiple 70mg dosing.
Data from multiple 45mg doses anticipated mid-2023; data from 70mg (single/multiple) expected H2 2023.
Company on track to complete Phase 1/2a studies in 2023 and initiate Phase 3 program in 2024.

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