Vanda And The NEREUS Launch Countdown

Vanda Pharmaceuticals (VNDA) is ending 2025 with the kind of headline biotech investors frame and hang on the wall. The FDA approved NEREUS (tradipitant) for the prevention of vomiting induced by motion, and it’s the first new pharmacologic treatment for the condition to get an FDA nod in more than 40 years.

The science story is clean and (for once) not written in invisible ink. The FDA approval was supported by two late-stage studies totaling 681 patients, where tradipitant significantly reduced vomiting. It works by blocking a brain receptor linked to nausea and vomiting. Vanda said it expects to launch NEREUS in the coming months.

This wasn’t just a finish line — it was a comeback tour. The FDA had placed a partial clinical hold on tradipitant in December 2018 tied to how motion sickness was classified. The agency lifted the hold on Dec. 4, 2025, after calling motion sickness an acute condition and dropping the prior chronic-toxicity study requirement. That’s the rare regulatory sentence that reads like "the paperwork monster has been defeated".

Vanda expects sales could exceed $100 million annually at peak in the U.S. — and the company has already flagged broader development work for tradipitant beyond motion sickness. The market potential for any new drug is huge, and Vanda seems to have NERUS on the right track. For now, investors have something to consider going into the new year - perhaps an opportunity that is as unique as the drug itself.

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