In a significant development for the treatment of motion sickness, Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) has received approval from the U.S. Food and Drug Administration (FDA) for its drug Nereus (tradipitant), indicated for the prevention of vomiting triggered by motion. This approval represents the first introduction of a novel pharmacologic therapy for this condition since the early 1980s.
The regulatory green light follows confirmatory evidence from several clinical trials encompassing real-world conditions and controlled settings. The safety and effectiveness of Nereus were established through three key studies, including two Phase 3 trials conducted aboard boats, named Motion Syros and Motion Serifos, as well as a supplementary study involving participants with pre-existing motion sickness histories.
Within the Motion Syros trial, which enrolled 365 participants, the incidence of vomiting among those treated with Nereus ranged from 18.3% to 19.5%, markedly lower than the 44.3% observed in the placebo group. Similarly, results from Motion Serifos, which involved 316 individuals, revealed vomiting rates between 10.4% and 18.3% with Nereus compared to 37.7% for placebo recipients, indicating risk reductions exceeding 50% and up to 70%.
Data consistently demonstrated not only the efficacy of tradipitant at reducing vomit episodes attributed to motion sickness but also revealed a safety profile compatible with acute therapeutic use. Furthermore, as recently as November 2025, a controlled clinical trial highlighted tradipitant’s potential to alleviate nausea and vomiting caused by GLP-1 receptor agonist therapy, with vomiting occurring in 29% of tradipitant-treated subjects versus 58.6% in placebo, reflecting a relative reduction of approximately half.
These data points have influenced a spectrum of cautious yet hopeful analyst commentary and corresponding price target revisions. Raghuram Selvaraju from HC Wainwright upgraded his price forecast from $20 to $22 while maintaining a Buy rating, noting that the FDA approval could signify an early phase shift in regulatory acceptance for tradipitant’s utility, especially considering its prospective application in more lucrative markets beyond motion sickness.
Madison El-Saadi of B Riley Securities maintained a Buy recommendation and elevated the price target to $14 from $11, emphasizing the approval as a reinforcement of Vanda’s ongoing turnaround narrative. El-Saadi further pointed out that shares remain undervalued heading into potential additional approvals anticipated within the year.
Conversely, Cantor Fitzgerald analyst Olivia Brayer reaffirmed an Outperform rating with an $11 target price but highlighted pricing as a crucial challenge. Brayer expects tradipitant to command a premium over existing over-the-counter (OTC) alternatives, which are widely accessible and less costly. To address cost concerns, Vanda intends to market an eight-tablet bottle estimated by Cantor to be priced above $500—a factor Brayer sees as influential in the drug’s commercial reception.
Jefferies’ Andrew Tsai retained a Hold rating while raising the price target from $5 to $7.50. Tsai projects a gradual uptake of Nereus as awareness expands among potential users, particularly those dissatisfied with current options or those who avoid travel due to motion sickness. However, he also notes that patient sensitivity to expense will shape adoption rates, given the availability of inexpensive remedies like dramamine.
Following the FDA announcement, Vanda Pharmaceuticals’ stock recorded a modest increase, trading up approximately 1.25% at $7.97 during Tuesday’s session. Market participants will likely monitor the drug’s market penetration, pricing strategy, and the company’s progress towards securing further regulatory approvals as key determinants of its medium-term performance.