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Stoke’s Phase III EMPEROR trial for zorevunersen in Dravet syndrome remains on track for a third-quarter 2027 data readout, with a potential U.S. regulatory submission later in 2027 and launch in early 2028. All 162 enrolled patients have passed week eight, and no discontinuations have been reported.
The FDA agreed that Stoke can use a multicomponent Vineland-3 endpoint covering cognition and behavior in its planned NDA. The company does not currently expect an FDA advisory committee meeting and plans to begin submitting materials in the first half of 2027.
Stoke ended the quarter with $358.8 million in cash, equivalents and marketable securities, which it expects—along with anticipated Biogen reimbursements and a potential milestone payment—to fund operations into early 2028. Its STK-002 Phase I trial for autosomal dominant optic atrophy is advancing, with initial higher-dose data expected in the first half of 2027.
Stoke Therapeutics (NASDAQ:STOK) said its Phase III EMPEROR trial of zorevunersen in Dravet syndrome is advancing toward a planned third-quarter 2027 data readout, while the company prepares for a potential U.S. regulatory submission later that year and a possible launch in early 2028.
The company also reported progress in its Phase I program for STK-002, an investigational treatment for autosomal dominant optic atrophy, or ADOA, and said its cash position is expected to fund operations into early 2028.
EMPEROR Trial Enrollment Advances
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Chief Executive Officer Ian Smith said all 162 patients enrolled in the global EMPEROR study have passed the week-eight point and received either two loading doses of zorevunersen or sham treatment. The double-blind, sham-controlled study is being conducted in the United States, United Kingdom and Japan.
Approximately 110 patients have completed the week-28 visit, when the primary endpoint of change in major motor seizure frequency is measured, while about 20 patients have completed the 52-week treatment period. All patients completing the treatment period have entered the open-label extension, and the company reported no treatment discontinuations to date.
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Chief Medical Officer Barry Ticho said the study originally targeted enrollment of 150 patients, based on an assumption that 128 patients would be evaluable after a projected 15% discontinuation rate. The company ultimately enrolled 162 patients and has not recorded any discontinuations.
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