Shares of Soleno Therapeutics (NASDAQ: SLNO) were skyrocketing 39.8% higher as of 10:51 a.m. ET on Monday. The huge gain came after the clinical-stage biopharmaceutical company announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to diazoxide choline for treating adults and children ages 4 and older with Prader-Willi syndrome (PWS) who have hyperphagia (abnormally high appetite).

PWS is a rare genetic disorder that causes individuals to constantly eat because they don't feel full. It occurs in 1 in every 15,000 live births. Soleno reported positive top-line results in September 2023 from a late-stage study evaluating diazoxide choline in treating PWS.

The FDA only grants Breakthrough Therapy Designation to drugs that target a serious condition when preliminary clinical data shows the drug could offer a significant clinical benefit over currently available therapies. This designation is a big deal for Soleno because it means the FDA will expedite the review of diazoxide choline.

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Source Fool.com