Stoke Therapeutics Inc. (STOK) announced accelerated timelines for its pivotal Phase 3 EMPEROR study. Enrollment of 150 patients is now expected to be completed in the second quarter of 2026, positioning the study for a data readout in mid-2027.
These results are anticipated to support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), with Stoke planning to initiate a rolling NDA submission in the first half of 2027.
As part of Zorevunersen's Breakthrough Therapy Designation, Stoke recently held a multidisciplinary meeting with the FDA to review the program and explore potential expedited regulatory pathways. While no immediate changes to the development plan were agreed upon, the FDA has requested additional information, and discussions remain ongoing regarding opportunities to accelerate the development, registration, and delivery of zorevunersen to patients.
By January 9, 2026, investigators had identified nearly 330 patients globally as potential candidates for the EMPEROR study. Of these, approximately 60 patients are undergoing the formal 8-week screening period prior to randomization, while another 60 have already advanced to randomization and dosing.
The company's financial position remains strong, with about $391.7 million in cash, cash equivalents, and marketable securities as of December 31, 2025. Together with eligible proceeds from its Biogen collaboration, Stoke expects to fund operations into 2028.
Shares of Stoke closed at $32.85 on January 9, down 2.46% on the day. Trading ranged between $32.46 and $34.34, with 52-week range of $5.35 to $38.69. Volume for the day was 674,168 compared to an average of 1,067,490.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.