VNDA Obtains FDA Nod for Motion Sickness Drug, Stock Gains

Vanda Pharmaceuticals, Inc. VNDA announced that the FDA has approved its candidate tradipitant for the prevention of vomiting induced by motion.

The drug has been approved under the brand name Nereus.

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company.

The announcement boosted investor sentiment, with VNDA shares jumping 18% in after-hours trading on Dec. 30 and extending gains in pre-market trading on Dec. 31.

More on VNDA’s Tradipitant

Per VNDA, this FDA approval represents the first new pharmacologic therapy for motion sickness in more than 40 years and marks a meaningful advance in the understanding and treatment of this debilitating physiological condition, which affects a large segment of the population and has long been recognized as a factor impacting military operational readiness.

The efficacy of Nereus is supported by robust evidence from three clinical studies, including two phase III real-world provocation trials conducted at sea — Motion Syros and Motion Serifos — as well as an additional supportive study, all involving participants with documented histories of motion sickness.

Vanda is currently evaluating tradipitant for gastroparesis, a chronic condition marked by delayed gastric emptying and persistent nausea and vomiting. The company is also investigating tradipitant for the prevention of nausea and vomiting associated with GLP-1 receptor agonists, a frequent side effect that can limit treatment adherence in the rapidly expanding obesity and diabetes therapy markets.

VNDA Stock Surges in Three Months

Shares of VNDA have surged 38.6% in the past three months compared with the industry’s growth of 13.9%.

In October, VNDA announced that it has agreed on a collaborative framework with the FDA for the resolution of certain disputes regarding Hetlioz (tasimelteon) and tradipitant.

Under the collaborative framework announced at that time, the FDA is conducting an expedited re-review of the partial clinical hold that currently prevents long-term clinical studies of tradipitant in motion sickness. The original target completion date of Nov. 26, 2025 has been extended to Dec. 5, 2025, at the FDA’s request and with Vanda’s agreement, to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research. All other terms of the collaborative framework remain unchanged.

The FDA and the company had also agreed to temporarily pause the ongoing administrative proceedings before the FDA Commissioner concerning VNDA’s new drug application for tradipitant in gastroparesis until Jan. 7, 2026. In addition, both parties sought a pause in VNDA’s lawsuit challenging the FDA’s practice of taking up to 12 months, rather than the statutory 180 days, to decide on new drug applications.

The FDA also agreed to undertake an expedited re-review of Vanda’s supplemental New Drug Application (sNDA) for Hetlioz in jet lag disorder by Jan. 7, 2026. The re-review will include consideration of alternative or more narrowly defined indications focused on the sleep-related aspects of jet lag disorder.

Vanda also agreed to withdraw its lawsuit related to its request to provide prescribers and patients with information on the efficacy of Hetlioz in treating jet lag disorder.

The company recently reported positive top-line results from a study evaluating tradipitant for the prevention of nausea and vomiting induced by Novo Nordisk’s NVO blockbuster GLP-1 RA for obesity, Wegovy (semaglutide), in overweight and obese adults.

Novo Nordisk’s Wegovy injection is approved for cardiovascular, HFpEF, liver and osteoarthritis indications.

Novo Nordisk also markets semaglutide as Ozempic injection and oral Rybelsus, both for diabetes.

Earlier in the month, VNDA submitted a BLA to the FDA for pipeline candidate imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations.

A potential approval of the candidate would expand VNDA’s expertise in rare and orphan diseases.

The company has multiple regulatory catalysts ahead, including FDA reviews of Bysanti (milsaperidone) for bipolar I disorder and schizophrenia, with a Feb. 21, 2026 target action date.

VNDA’s Zacks Rank and Stocks to Consider

Vanda Pharmaceuticals currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the pharma/biotech sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.56. EPS estimates for 2026 have increased from $7.81 to $8.08 during the same period. Year to date, shares of ANIP have surged 43.6% in the past year.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has risen 54.2% in the past year. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.


 

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