Soleno Therapeutics falls as FDA extends review of genetic disorder drug

Soleno Therapeutics

26/11/2024 14:18

** Shares of drug developer Soleno Therapeutics  SLNO.O 
fall ~6% to $54 premarket  
    ** Co says U.S. FDA has extended review of its experimental
drug to treat Prader–Willi syndrome, a rare genetic disorder
    ** The condition causes affected individuals to develop
extreme hunger, which leads to chronic overeating, or
hyperphagia, and obesity  
    ** FDA determined that co's responses to recent information
requests constituted major amendment to marketing application
for the drug, diazoxide choline extended-release tablets 
    ** The health regulator will now give its decision by March
27, 2025, compared with its previous action date of Dec. 27 this
year
    ** FDA did not cite any safety, efficacy or manufacturing
concerns, SLNO says
    ** Up to last close, stock up ~42% YTD

 (Reporting by Mariam Sunny in Bengaluru)
 ((Mariam.ESunny@thomsonreuters.com;))