Stoke Therapeutics targets early 2028 U.S. launch for Dravet drug zorevunersen after FDA alignment meeting

By Public Technologies
  • Stoke Therapeutics aligned with the FDA on its planned U.S. NDA for zorevunersen in Dravet syndrome.
  • Five years of safety and efficacy evidence from earlier studies was reviewed; Phase 3 EMPEROR results are expected in Q3 2027.
  • NDA package will include a revised assessment of cognition and behavior in EMPEROR, aiming to better capture meaningful patient change.
  • Data submissions are planned through H1 2027, targeting NDA completion in H2 2027 with a potential U.S. launch in early 2028.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Stoke Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20261005238322) on October 05, 2026, and is solely responsible for the information contained therein.

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