Stoke Therapeutics targets Q1 2027 for rolling NDA submission, backed by $411M cash, with Phase III enrollment slated for June.
Stoke Therapeutics announced plans to initiate a rolling New Drug Application (NDA) in Q1 2027, supported by a $411M cash balance. The company aims to complete enrollment for its Phase III EMPEROR trial by June this year.
Management outlined the timeline during its Q1 2026 earnings call, emphasizing progress toward regulatory and clinical milestones. The $411M cash position is expected to fund operations into 2027, aligning with the NDA filing target.
No immediate market reaction was disclosed in the update.