Soleno Therapeutics Reports Strong Long-Term Data for Proposed Treatment

By Colin Kellaher

Shares of Soleno Therapeutics, a biopharmaceutical company based in Redwood City, California, surged over 360% after the release of promising long-term data for their potential treatment for Prader-Willi syndrome, a genetic disorder that can lead to obesity, diabetes, and cardiovascular disease. As a result, the stock reached a new 52-week high of $25, compared to its low of 85 cents in December of last year.

The company announced that the withdrawal phase of the long-term study, which evaluated the efficacy of diazoxide choline extended-release tablets, successfully achieved its primary endpoint. This included a significant improvement in behaviors associated with hyperphagia, a condition characterized by a constant and life-threatening sensation of intense hunger. Notably, hyperphagia-related behaviors worsened in a group of patients who transitioned from taking diazoxide choline to a placebo after two to four years.

Soleno Therapeutics revealed plans to seek approval from the U.S. Food and Drug Administration for the drug in mid-2024.

In addition, the company emphasized that a securities purchase agreement reached in December 2022 requires a group of investors to exercise warrants to purchase approximately 8.6 million shares at $1.75 per share, amounting to around $15 million, within 30 days of the announcement of positive top-line data from the study.