Soleno Therapeutics shares more than quadrupled on Tuesday after the biopharmaceutical company reported strong long-term data for its proposed treatment for a genetic disorder that can lead to obesity, diabetes and cardiovascular disease.
Shares of the Redwood City, Calif., company were recently changing hands at $20.33, up nearly 360%, after hitting a new 52-week high of $25 earlier in the session. The stock had traded as low as 85 cents last December.
Soleno said the withdrawal period of its long-term treatment study of diazoxide choline extended-release tablets in Prader-Willi syndrome met its primary endpoint in change from baseline in behaviors related to hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger.
Soleno said hyperphagia-related behaviors markedly worsened in a group of patients who had been taking diazoxide choline for two to four years and were then switched to placebo for four months.
The company said it plans to file for U.S. Food and Drug Administration approval of the drug in mid-2024.
Soleno also noted that under its December 2022 securities purchase agreement with a trio of investors, the group is required to exercise warrants to buy nearly 8.6 million shares at $1.75 apiece, or about $15 million, within 30 days of the announcement of positive top-line data from the study.