Why Is VNDA Stock Surging Premarket? FDA Approves Motion Sickness Drug

Vanda Pharmaceuticals Inc. (VNDA) stock is experiencing a dramatic surge in premarket trading, jumping 18.63% to $8.34 as of 6:03 AM EST on December 31, 2025. The rally comes after the company announced that the U.S. Food and Drug Administration has approved NEREUS™ (tradipitant) for the prevention of vomiting induced by motion, marking the first new pharmacologic treatment for motion sickness in over four decades.

This historic approval represents a significant milestone for the biopharmaceutical company and addresses a condition affecting tens of millions of Americans annually.

FDA Approves First New Motion Sickness Drug in Over 40 Years

The FDA’s approval of NEREUS™ marks a watershed moment in motion sickness treatment, as it’s the first novel therapy approved for this condition since the early 1980s. The drug, an oral neurokinin-1 (NK-1) receptor antagonist, works by blocking a brain receptor linked to nausea and vomiting, offering a modern neuropharmacological approach to prevention.

Vanda expects to launch NEREUS™ in the coming months, with analyst Raghuram Selvaraju from H.C. Wainwright projecting that sales could exceed $100 million annually at peak in the U.S. alone.

The approval was supported by robust clinical data from three pivotal trials involving 681 patients total, including two Phase 3 real-world studies conducted on boats. In the Motion Syros study with 365 participants, vomiting incidence was reduced to 18.3-19.5% with NEREUS™ versus 44.3% with placebo, while the Motion Serifos study showed even better results with vomiting rates of 10.4-18.3% compared to 37.7% with placebo.

These trials demonstrated risk reductions of over 50-70%, establishing NEREUS™’s efficacy in preventing motion-induced vomiting.

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FDA Approval Lifts Shares and Growth Expectations

Prior to the approval announcement, VNDA closed at $7.03 on December 30, down 2.36%, but the premarket surge has pushed the stock to $8.34, representing a gain of $1.31 per share. The stock has shown strong year-to-date performance with a 46.76% return, significantly outperforming the S&P 500‘s 17.25% gain.

With a market capitalization of $415.45 million and 368 full-time employees, Vanda is positioning itself to capture a significant portion of the motion sickness treatment market, which affects approximately 25-30% of adults, roughly 65-78 million people in the U.S.

The company is also advancing tradipitant in clinical development for additional indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists, a common side effect in the rapidly growing obesity and diabetes treatment landscape. Vanda licensed tradipitant from Eli Lilly in 2012 and has been testing it for several uses.

The FDA had originally placed a partial clinical hold on the drug in December 2018, but lifted it on December 4, 2025, calling motion sickness an acute condition rather than chronic, which paved the way for this approval.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.