(Reuters) – The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals’ drug to treat stomach paralysis symptoms, the company said on Thursday.
Shares of the company fell about 14% to $4.26 in premarket trading.
Vanda was seeking the health regulator’s nod for the drug tradipitant to treat gastroparesis, a condition characterized by delayed gastric emptying.
The disease is associated with symptoms such as severe nausea, vomiting, and difficulty finishing a normal meal.
Vanda licensed tradipitant from Eli Lilly and is also studying it for motion sickness.
The health regulator had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks.
The company plans to submit a separate application for the drug to prevent vomiting in motion sickness later this year.
(Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan)
Comments