Zorevunersen

FDA grants Breakthrough Therapy designation to Stoke Therapeutics' zorevunersen (STK-001) for Dravet syndrome, showing potential as a disease-modifying therapy. Shares rose 12.1% on Dec. 4. Zorevunersen demonstrated substantial reductions in seizure frequency and cognitive improvements in phase I/IIa and OLE studies. Stoke is discussing a global phase III study with FDA and other agencies, with an update expected by 2024-end.

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Stoke Therapeutics' zorevunersen receives FDA Breakthrough Therapy Designation for treating Dravet syndrome, based on Phase 1/2a and OLE study results showing significant seizure reduction and cognitive improvements. The company plans a global Phase 3 study by year-end.

Stoke Therapeutics' shares rose 7% after FDA granted breakthrough-therapy designation to zorevunersen for treating Dravet syndrome with SCN1A gene mutation. Stoke expects to update on Phase 3 study plans by year-end.

Stoke Therapeutics received FDA Breakthrough Therapy Designation for zorevunersen, targeting Dravet syndrome with SCN1A gene mutations. Discussions on a global Phase 3 study continue, with plans for an update by year-end.

Stoke Therapeutics received FDA Breakthrough Therapy Designation for zorevunersen, its Dravet syndrome treatment, potentially expediting its development. Clinical trials showed significant seizure reduction and cognitive improvements. The company plans a global Phase 3 study, with an update expected by year-end. Zorevunersen targets the genetic cause of Dravet syndrome, aiming to restore normal protein levels.

Stoke Therapeutics received FDA Breakthrough Therapy Designation for zorevunersen, treating Dravet syndrome with SCN1A gene mutations, showing substantial seizure frequency reduction, cognitive and behavioral improvements, and over 600 doses administered.