7/102 sources · 2 publishersUpdated Oct 8, 21:00 UTC
Stoke aligns U.S. filing plan for zorevunersen with FDA
Stoke Therapeutics completed an FDA meeting on its planned U.S. New Drug Application for zorevunersen, its investigational Dravet syndrome treatment. The agency gave feedback on the filing timetable, required evidence and analytical approach. Stoke expects to provide data during the first half of 2027 and finish the NDA after a Phase 3 readout expected in the third quarter of 2027.
Why it matters
The FDA discussion clarifies the planned U.S. filing path for Stoke's lead program. The company plans to use a four-part Vineland-3 assessment in the Phase 3 EMPEROR trial to measure cognitive and behavioral change.
Key facts
- 1Stoke said its FDA meeting addressed its intended U.S. NDA filing for zorevunersen, an investigational therapy for Dravet syndrome. investing.com
- 2The company said the FDA commented on the proposed timetable, data needs and analysis methods for the submission. investing.com
- 3Stoke plans to provide supporting data during the first half of 2027 and complete the U.S. NDA submission during the second half of 2027. investing.com
- 4The Phase 3 EMPEROR study is expected to report results in the third quarter of 2027. investing.com
- 5Stoke said it had finished enrollment in the United States, United Kingdom and Japan in June, while recruitment in China continued. investing.com
- 6Stoke has a development and commercialization collaboration with Biogen for zorevunersen in Dravet syndrome. investing.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.