Stoke Therapeutics Shares Rise Premarket on Key FDA Designation

Dow Jones

Dec 04, 2024

By Colin Kellaher

Shares of Stoke Therapeutics rose more than 7% in premarket trading Wednesday after the biotechnology company said it has received Food and Drug Administration breakthrough-therapy designation for its zorevunersen proposed treatment for a severe genetic epilepsy.

Stoke said the designation covers zorevunersen, which it is developing as a disease-modifying medicine, for the treatment of Dravet syndrome with a confirmed mutation, not associated with gain-of-function, in the SCN1A gene.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.

Stoke said talks with the FDA and other global regulatory agencies regarding a Phase 3 registrational study of zorevunersen continue, adding that it expects to provide an update on its study plans by the end of the year.

Shares of the Bedford, Mass., company, which closed Tuesday at $11.43, were recently up 7.2% at $12.25 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 04, 2024 07:39 ET (12:39 GMT)

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