NEW YORK, December 31, 2025, 04:27 ET — Premarket
- Vanda shares jumped about 18% in premarket trading after the FDA approved Nereus (tradipitant). StockAnalysis+1
- The company said it expects to launch the oral drug in the coming months, putting pricing and early uptake in focus. Reuters+1
- Analysts and investors are watching whether the approval can open a meaningful new revenue stream for the small-cap biotech. Reuters
Vanda Pharmaceuticals’ shares surged about 18% in premarket trading on Wednesday after the U.S. Food and Drug Administration approved its motion-sickness vomiting drug, Nereus (tradipitant). StockAnalysis+1
The approval matters now because Vanda is moving from a long-running regulatory story to a commercial one, with investors shifting quickly to questions of launch execution, insurance coverage and pricing. The company said it expects to launch Nereus in the coming months. Reuters+1
It also gives Vanda a fresh catalyst heading into year-end trading, when extended-hours moves can be amplified by thinner liquidity. Shares closed at $7.03 on Tuesday and were indicated around $8.30 in early premarket trade. StockAnalysis
Vanda said Nereus is an oral neurokinin-1 (NK-1) receptor antagonist — a drug that blocks a pathway in the brain linked to nausea and vomiting. PR Newswire+1
The FDA’s decision was based on two late-stage studies involving 681 patients, Reuters reported, in which tradipitant significantly reduced vomiting. Motion-induced vomiting can be triggered when signals from the eyes and inner ear don’t match, such as during travel. Reuters
“Sales of tradipitant solely in this indication could exceed $100 million annually at peak in the U.S. alone,” H.C. Wainwright analyst Raghuram Selvaraju said in a note cited by Reuters. Reuters
Vanda’s entry sets it against entrenched motion-sickness options, including Viatris’ prescription scopolamine patch Transderm Scop and over-the-counter brands such as Bonine and Dramamine, Reuters reported. Reuters
The approval follows a recent regulatory turn. In a December 4 filing and attached company release, Vanda said the FDA lifted a partial clinical hold after agreeing motion sickness is an acute, self-limiting condition — a shift that removed a requirement for an additional six-month dog toxicity study. SEC
Tradipitant was licensed from Eli Lilly in 2012, and Vanda has been testing it in other settings, including gastroparesis and nausea linked to certain diabetes and obesity drugs, Reuters reported. Vanda said it is also advancing tradipitant in gastroparesis and for nausea and vomiting tied to GLP-1 receptor agonists. Reuters+1
Broader biotech trading was softer in early moves, with the SPDR S&P Biotech ETF and iShares Nasdaq Biotechnology ETF both down about 1% in premarket indications.
Investors will be watching for Vanda’s next disclosures on pricing and the shape of the launch, after Reuters said the company did not immediately respond to a request for comment on pricing. Reuters
They will also scrutinize the label and tolerability profile as the drug rolls out. In its release, Vanda flagged somnolence and fatigue among adverse reactions seen in placebo-controlled trials, and said the drug may impair the ability to drive or operate machinery. PR Newswire
