Vanda Pharmaceuticals Inc. shares surged more than 20% in after-hours trading on Tuesday after the FDA approved its oral drug NEREUS to prevent motion-induced vomiting in adults, marking the first new therapy in decades.
Vanda Pharmaceuticals Inc. said Tuesday the U.S. Food and Drug Administration approved NEREUS, also known as tradipitant, an oral neurokinin-1 receptor antagonist designed to prevent motion-induced vomiting in adults. The announcement sent the Washington-based company’s shares up 20.20% to $8.45 in after-hours trading, according to Benzinga data.
The approval gives patients a new treatment option for motion sickness, a condition that affects a significant portion of the U.S. population during routine travel. Company officials said the drug will be launched in the coming months.
FDA Decision Drives After-Hours Rally
Shares of Vanda Pharmaceuticals closed Tuesday at $7.03, down 2.36% during regular trading, before reversing sharply higher after the FDA decision was announced, according to Benzinga Pro. The company has a market capitalization of about $415 million.
“For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology,” said Mihael H. Polymeropoulos, Vanda’s president, chief executive officer and chairman, in a statement announcing the approval.
The stock is trading near its 52-week high following the move. Vanda shares have gained about 47% over the past 12 months, reflecting sustained investor interest tied to regulatory progress and pipeline development.
NEREUS is licensed from Eli Lilly and Co., which originally developed the compound. Vanda holds commercialization rights and will oversee the product’s U.S. launch.
Trial Results Show Significant Risk Reduction
The FDA approval was supported by data from three pivotal clinical trials that showed the drug significantly reduced vomiting compared with placebo, Vanda Pharmaceuticals said.
In the Motion Syros trial, which enrolled 365 patients, vomiting occurred in 18.3% to 19.5% of patients treated with NEREUS, compared with 44.3% in the placebo group. The difference was statistically significant, with a p-value of less than 0.0001.
A second study, Motion Serifos, included 316 patients and reported vomiting rates ranging from 10.4% to 18.3% among those receiving NEREUS, versus 37.7% for patients given a placebo. Vanda said this represented risk reductions of more than 50% to 70%.
Common adverse reactions reported in the trials included somnolence in 6% to 12% of patients and fatigue in 6% to 8%, according to the company.
Vanda said the safety profile was consistent across studies and supported the FDA’s decision to approve the drug for adult use.
Market Opportunity and Broader Pipeline
Vanda Pharmaceuticals estimates that about 25% to 30% of U.S. adults, or roughly 65 million to 78 million people, experience motion sickness during routine travel. The company said about 5% to 15% of adults suffer from severe and recurrent symptoms.
Analysts say the size of that population highlights a sizable commercial opportunity if NEREUS gains broad adoption. The company has not disclosed pricing details.
Beyond motion sickness, Vanda is continuing clinical development of tradipitant for other indications, including gastroparesis, a chronic gastrointestinal disorder. The drug is also being studied for the prevention of nausea and vomiting associated with GLP-1 receptor agonists, which are widely used to treat diabetes and obesity.
Technical indicators tracked by Benzinga show the stock’s relative strength index at 65.44, suggesting strong momentum without entering deeply overbought territory. The stock is trading at about 88% of its 52-week range.
Vanda Pharmaceuticals said additional updates on the NEREUS launch and ongoing clinical programs are expected in the coming months as it expands its commercial and development efforts.
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