Stoke Therapeutics, Inc. (Nasdaq: STOK) has announced the initiation of a global Phase 3 registrational study, named EMPEROR, for their lead investigational medicine, zorevunersen, aimed at treating Dravet syndrome. Following successful regulatory alignment with the FDA, EMA, and Japan's PMDA, the study is set to commence in the second quarter of 2025. This strategic move is bolstered by a collaboration with Biogen, which enables commercialization capabilities for rare genetic diseases. Stoke retains exclusive rights in the U.S., Canada, and Mexico, with Biogen covering the rest of the world. The anticipated data readout in the second half of 2027 is expected to support global regulatory filings, positioning zorevunersen as a potential first-in-class disease-modifying treatment for Dravet syndrome.
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