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Stoke Therapeutics Discusses Vineland-3 Endpoint with FDA Ahead of Zorevunersen Dravet NDA

🇺🇸 Stoke Therapeutics, Inc. (STOK) · Thu 29 Oct 2026

Stoke says its FDA meeting covered analysis of a cognition and behaviour secondary endpoint in the Phase 3 EMPEROR study, with topline data due in Q3 2027.

Stoke Therapeutics has said it met with the US Food and Drug Administration to discuss its planned new drug application for zorevunersen in Dravet syndrome. The company disclosed the meeting on 29 October 2026 alongside its third-quarter results.

According to the company, the discussion covered how the cognition and behaviour secondary endpoint in the Phase 3 EMPEROR study will be analysed. The approach uses four subdomains of the Vineland-3 assessment. The summary available does not detail the outcome of the meeting beyond this scope, nor which subdomains are involved.

Stoke expects topline data from EMPEROR in the third quarter of 2027 and plans to submit the NDA in the second half of 2027.

On financing, the company reported cash of $358.8 million. It expects this to fund operations into early 2028, a period that would extend only a short way beyond the planned NDA submission.

What it means for your team

  • Regulatory teams in rare neurological disease should note that agreement on how a secondary functional endpoint is analysed is being settled with the FDA before data readout.
  • The stated timeline, with topline data in Q3 2027 and NDA submission in H2 2027, sets the earliest window for any FDA review of zorevunersen.
  • Market-access teams tracking Dravet syndrome can use the cognition and behaviour endpoint as a signal of the evidence likely to feature in future payer discussions, though no data have yet been reported.

Company's press release (SEC filing): Stoke Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Stoke Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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