The European Medicines Agency (EMA) issued an opinion on February 26, 2026 recommending that it refuse marketing authorization for Vanda Pharmaceuticals’ iloperidone for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. The decision was made public on February 27, 2026, and it bars Vanda from commercializing the drug in the European market.
The EMA’s assessment cited pronounced QT prolongation as a significant safety concern, stating that the risk was not outweighed by the observed benefits. The agency also noted a delayed onset of effect and insufficient data beyond four weeks of treatment for bipolar I disorder, concluding that the clinical data did not meet the necessary efficacy or safety thresholds.
The refusal eliminates a potential revenue stream that had been part of Vanda’s long‑term pipeline strategy. In response, the company is reallocating resources toward other assets, notably Bysanti (milsaperidone) and tradipitant. Bysanti received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026, with commercial availability expected in Q3 2026. Tradipitant (NEREUS) was approved for motion sickness in late 2025.
Vanda’s 2025 financial results provide context for the impact of the regulatory setback. Total revenue rose 9% to $216.1 million, driven by strong Fanapt sales, while the company posted a net loss of $220.5 million, a sharp increase from the $18.9 million loss in 2024, largely due to a one‑time tax charge. Management has guided 2026 revenue to between $230 million and $260 million from its currently commercialized products, indicating a cautious outlook amid the setback.
Investors reacted with caution, reflecting concerns over regulatory risk and the company’s heavy losses, while some analysts noted the recent FDA approval of Bysanti as a potential offset.
Mihael H. Polymeropoulos, M.D., President, CEO, and Chairman of the Board, said, "The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage. BYSANTI™ exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health."
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