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Vanda Pharma (VNDA) is surging to multi-year highs after announcing that the FDA has approved NEREUS for the prevention of vomiting induced by motion, marking a pivotal regulatory win for the company. The approval significantly expands VNDA’s commercial opportunity and meaningfully improves its long-term growth outlook, with NEREUS expected to become a core revenue driver following a planned commercial launch in 1H26.

• FDA approval was supported by three positive clinical trials, which consistently demonstrated that NEREUS significantly reduced the incidence and severity of motion-induced vomiting versus placebo across multiple motion settings, including real-world and controlled exposure environments.
• Efficacy data showed a robust and durable anti-vomiting effect, with patients experiencing meaningful protection during prolonged motion exposure, addressing a key unmet need for individuals who do not respond adequately to existing therapies.
• Safety and tolerability were favorable across the clinical program, with no serious treatment-related adverse events reported; the most common side effects were mild and transient, supporting NEREUS as a well-tolerated option suitable for broad use, including repeat dosing scenarios.
• The total addressable market is substantial, with an estimated 65–78 mln adults in the U.S. affected by motion sickness, spanning civilian use (travel, commuting, leisure activities) and the military market, where motion-induced vomiting remains a persistent operational challenge in aviation, naval, and ground transport settings.
• From a financial standpoint, NEREUS has the potential to exceed $100 mln in annual sales, which is highly impactful given expectations for approximately $269 mln in total FY26 revenue, making this approval a clear game-changer for VNDA’s revenue trajectory and valuation profile.
• Strategically, NEREUS complements VNDA’s existing portfolio by diversifying revenue beyond its current neuropsychiatric and rare-disease treatments, while also strengthening the company’s competitive position against older, less targeted motion sickness therapies that often carry sedating side effects.

Briefing.com Analyst Insight:

VNDA’s FDA approval of NEREUS represents a transformational milestone that materially enhances the company’s growth profile and investor perception. The strength and consistency of the clinical data, combined with a clean safety profile, support broad adoption potential across both civilian and military markets. With motion sickness affecting tens of millions of adults and limited innovation in this space historically, NEREUS appears well positioned to capture meaningful share. Importantly, the prospect of $100+ mln in peak annual sales stands out against VNDA’s expected FY26 revenue base, underscoring why the stock is reacting so positively. Execution around the 1H26 launch will be critical, but this approval clearly reshapes the company’s long-term opportunity set.