(RTTNews) - Stoke Therapeutics (STOK) announced that it has received Breakthrough Therapy Designation from the FDA for zorevunersen for the treatment of Dravet syndrome with a confirmed mutation, not associated with gain-of-function, in the SCN1A gene. The company said discussions with the FDA and other global regulatory agencies regarding a global, randomized, controlled Phase 3 registrational study of zorevunersen continue to progress. The company plans to provide an update on Phase 3 registrational plans by the end of the year.
Zorevunersen is being developed as potentially the first disease-modifying medicine for the treatment of Dravet syndrome.
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