Soleno Therapeutics Shares Rise 37% After Breakthrough Designation for Diazoxide Choline

Dow Jones04-29

By Chris Wack

Soleno Therapeutics were trading near a three-year high after the Food and Drug Administration granted breakthrough therapy designation for diazoxide choline extended-release tablets to treat people 4 years and older with genetically confirmed Prader-Willi syndrome who have hyperphagia.

Shares were 37% higher at $52 a share in midmorning trading. It hit an intra-day high of $53.82 on Feb. 28.

The biopharmaceutical company said the designation shows that diazoxide choline may demonstrate substantial improvement on clinically significant endpoints over available therapies.

Soleno expects to submit a New Drug Application for diazoxide choline in mid-2024.

The FDA's breakthrough therapy designation aims to expedite the development and review of drugs intended to treat a serious condition.

Diazoxide choline has an orphan drug designation for Prader-Willi syndrome in the U.S. and E.U., as well as a fast track designation in the U.S.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 29, 2024 10:45 ET (14:45 GMT)

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

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