Vanda Pharma Shares Jump as FDA Lifts Hold on Motion Sickness Drug
The decision removes a key hurdle for tradipitant, positioning it to potentially become the first new treatment for motion sickness in over four decades.
Shares of Vanda Pharmaceuticals (NASDAQ: VNDA) surged in trading after the U.S. Food and Drug Administration lifted a partial clinical hold on its experimental motion sickness drug, tradipitant. The regulatory green light clears a significant obstacle for the drug's development and revitalizes prospects for what could be the first new pharmacologic treatment for motion sickness in more than 40 years.
Vanda's stock jumped more than 10% in after-hours trading on the news, reflecting investor optimism for the drug candidate's path to market. The company confirmed in a press release that the FDA's decision followed a formal dispute resolution process, effectively removing the requirement for an additional long-term toxicology study in dogs. The agency reportedly concurred that since motion sickness is an acute, event-driven condition, the extended study was not necessary for the drug's safety profile review.
The partial clinical hold was originally placed on the tradipitant program in 2023, creating uncertainty around its timeline and ultimate approvability. With the hold now lifted, Vanda can proceed with its New Drug Application (NDA) for tradipitant, which has a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
Tradipitant, a neurokinin-1 (NK1) receptor antagonist, has shown promising results in clinical trials. Vanda previously reported positive data from its Phase III studies, where participants treated with tradipitant demonstrated a statistically significant reduction in the risk of vomiting compared to placebo. If approved, the drug would enter a market that has seen little innovation for decades, currently dominated by older, often sedating antihistamines like dimenhydrinate (Dramamine) and scopolamine.
The market for motion sickness treatments is substantial, affecting a large portion of the population during travel by air, sea, or land. The development of a novel, non-drowsy alternative represents a significant commercial opportunity for Vanda, a Washington, D.C.-based biopharmaceutical firm with a market capitalization of approximately $290 million.
Prior to the announcement, Vanda's shares had been trading near their 52-week high. The news provides a significant catalyst for the company, which focuses on therapies for central nervous system disorders. While some analysts have remained cautious citing the company's broader financial picture, others see substantial upside. The consensus analyst price target for VNDA stood at $11.75 before the recent surge, suggesting a belief in the underlying value of the company's pipeline.
This regulatory victory is a critical step forward for Vanda and its lead drug candidate. As the company moves toward its PDUFA date late next year, investors and industry observers will be closely watching for further updates. The successful commercialization of tradipitant could be transformative for Vanda, providing a major new revenue stream and validating its clinical development strategy.