Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) received U.S. Food and Drug Administration approval for its new drug BYSANTI (milsaperidone) on February 20, 2026. The approval covers the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia in adults, marking the first regulatory clearance for BYSANTI, a new‑chemical‑entity atypical antipsychotic that interconverts to iloperidone in the body.
The combined U.S. market for bipolar I disorder and schizophrenia is estimated at $10 billion annually. BYSANTI adds to Vanda’s portfolio beyond its existing Fanapt and HETLIOZ lines, leveraging the clinical heritage of iloperidone and positioning the company to capture a share of this sizable market.
Commercial availability of BYSANTI is expected in the third quarter of 2026, correcting the earlier claim of a first‑half launch. This timeline aligns with Vanda’s guidance and the company’s planned commercial rollout.
Vanda’s recent financial results provide context for the approval. In its February 11, 2026 earnings release, the company reported full‑year 2025 revenue of $216.1 million, up 9% from 2024, and Fanapt net product sales of $117.3 million, a 24% increase. Net loss for the year was $220.5 million, largely driven by a $113.7 million one‑time tax charge. Q4 2025 revenue of $56.3 million rose 5.8% YoY but fell short of analyst estimates. Guidance for 2026 revenue is $230 million to $260 million, below the consensus estimate of $271.3 million.
CEO Mihael H. Polymeropoulos highlighted BYSANTI as a new era of accelerated innovation, noting Fanapt’s strong momentum with 24% sales growth driven by prescription increases. He emphasized the company’s confidence in the new product’s potential to broaden its therapeutic reach.
The approval was well received by investors, reflecting enthusiasm for the new product and the company’s expanding portfolio. BYSANTI competes with established treatments such as Bristol Myers Squibb’s Cobenfy and Johnson & Johnson’s Caplyta in the schizophrenia and bipolar markets.
The approval also underscores Vanda’s strategy of leveraging its existing clinical data to accelerate development of new indications, positioning the company for future growth in behavioral health.
The company’s recent financial performance, including significant net losses and a one‑time tax charge, highlights the importance of the new product as a potential revenue driver and a means to offset current headwinds.
The approval aligns with Vanda’s broader pipeline, which includes NEREUS for motion sickness and ongoing studies of BYSANTI for treatment‑resistant major depressive disorder, indicating a continued focus on expanding its psychiatric portfolio.
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