Soleno Shares Soar Premarket on FDA Approval of Vykat XR

Dow Jones

Mar 27, 2025

By Colin Kellaher

Shares of Soleno Therapeutics took flight in premarket trading Thursday after the biopharmaceutical company won U.S. Food and Drug Administration approval of its treatment for a genetic disorder that can lead to obesity, diabetes and cardiovascular disease.

Soleno on Wednesday said the FDA approved its Vykat XR extended-release tablets for the treatment of hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, in people ages 4 and older with Prader-Willi syndrome.

The Redwood City, Calif., company said the green light makes Vykat XR the first FDA-approved therapy to address hyperphagia in individuals with Prader-Willi syndrome, a rare genetic neurodevelopmental disorder, adding that it expects the drug to be available in the U.S. beginning next month.

Soleno shares, which closed Wednesday at $48.97, were recently up 38% at $67.50 in premarket trading.

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

(END) Dow Jones Newswires

March 27, 2025 06:07 ET (10:07 GMT)

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