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Stoke Therapeutics Accelerates Phase 3 Dravet Study Timeline

Story Highlights
  • Stoke Therapeutics accelerated its Phase 3 EMPEROR trial timeline for zorevunersen, targeting enrollment completion in Q2 2026 and a mid-2027 data readout to support a rolling FDA submission.
  • Ongoing FDA discussions, strong global trial enrollment and funding through 2028 position Stoke to advance zorevunersen toward potential approval in a market lacking disease-modifying Dravet treatments.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Stoke Therapeutics Accelerates Phase 3 Dravet Study Timeline

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Stoke Therapeutics ( (STOK) ) has provided an update.

On January 11, 2026, Stoke Therapeutics announced updated, accelerated timelines for its Phase 3 EMPEROR study of zorevunersen in Dravet syndrome, now expecting to complete enrollment of 150 patients in the second quarter of 2026 and to deliver a Phase 3 data readout in mid-2027 that is intended to support a rolling New Drug Application to the U.S. Food and Drug Administration starting in the first half of 2027. Following a recent multidisciplinary meeting held as part of zorevunersen’s Breakthrough Therapy Designation, the FDA requested additional information and made no immediate changes to the development program, but discussions continue around potential expedited pathways, while strong enrollment momentum, a global trial footprint, and a cash position of about $391.7 million as of December 31, 2025—together with collaboration proceeds from Biogen, expected to fund operations into 2028—underscore Stoke’s capacity to advance zorevunersen toward potential registration and commercialization in a field that currently lacks disease-modifying therapies for Dravet syndrome.

The most recent analyst rating on (STOK) stock is a Buy with a $39.00 price target. To see the full list of analyst forecasts on Stoke Therapeutics stock, see the STOK Stock Forecast page.

Spark’s Take on STOK Stock

According to Spark, TipRanks’ AI Analyst, STOK is a Outperform.

Stoke Therapeutics demonstrates strong technical indicators and positive corporate developments, which are offset by valuation concerns and cash flow volatility. The company’s strategic initiatives and leadership changes are promising for future growth.

To see Spark’s full report on STOK stock, click here.

More about Stoke Therapeutics

Stoke Therapeutics is a Bedford, Massachusetts-based biotechnology company focused on restoring protein expression using RNA medicines, specifically antisense oligonucleotides developed through its proprietary TANGO platform. Its lead investigational therapy, zorevunersen, is being co-developed with Biogen as a first-in-class, potentially disease-modifying treatment for Dravet syndrome, with Stoke retaining commercialization rights in North America and Biogen holding rights in the rest of the world; the company’s initial focus is on central nervous system and eye diseases caused by haploinsufficiency, with broader potential applications demonstrated in other tissues.

Average Trading Volume: 1,073,966

Technical Sentiment Signal: Buy

Current Market Cap: $1.92B

Learn more about STOK stock on TipRanks’ Stock Analysis page.

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