Longboard Pharmaceuticals Shares Rise on FDA's Designations For Dravet Syndrome Treatment

Dow Jones09-19

By Michael Susin

Longboard Pharmaceuticals shares rose on Thursday after the Food And Drug Administration granted pediatric disease designation and orphan drug designation for its investigational drug bexicaserin for the treatment of Dravet syndrome.

Shares in premarket trading were up 4.2% to $30.53. Over the last 52 weeks, shares saw a more than four fold increase.

The biopharmaceutical company said the grant of the orphan drug designation provides regulatory support for the development of bexicaserin, with the potential for seven years of market exclusivity after approval. It added that the rare pediatric disease designation gives the opportunity to qualify for a priority review voucher that can be used to receive priority review for a different product or to sell or transfer the voucher to another sponsor.

Bexicaserin is currently under study for the treatment of Dravet syndrome, a genetic epilepsy that begins in the first year of life, and is not approved for marketing by the FDA or any other regulatory authority.

The company said it expects to start its late stage study in the coming weeks.

Write to Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

September 19, 2024 09:25 ET (13:25 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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