This article first appeared on GuruFocus.
Vanda Pharmaceuticals (NASDAQ:VNDA) jumped roughly 21% in premarket trading after the U.S. Food and Drug Administration approved its motion sickness therapy Nereus, also known as tradipitant, a drug developed in partnership with Eli Lilly (NYSE:LLY). The approval allows the oral therapy to be marketed in the U.S. for the acute prevention of vomiting induced by motion, according to a company statement released Tuesday evening, setting the stage for a commercial launch in the coming months.
The FDA’s decision was backed by data from three pivotal clinical trials, where tradipitant reduced the incidence of vomiting and showed a safety profile considered compatible with acute use. The drug is a neurokinin-1 receptor antagonist, and its approval could represent the first new pharmacologic treatment for motion sickness in more than four decades, a condition often described as a physiologic response that can also affect military readiness.
Beyond motion sickness, Vanda is continuing to advance tradipitant for additional indications, including nausea and vomiting linked to GLP-1 therapies. The drug was licensed from Eli Lilly under a 2012 agreement, and the FDA approval could potentially mark a significant milestone for Vanda as it expands the clinical and commercial scope of its pipeline.