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WASHINGTON - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a biopharmaceutical company with impressive gross profit margins of 94% and a current market capitalization of $269 million, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational antipsychotic drug, Bysanti™ (milsaperidone). According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet. The FDA has not identified any potential review issues at this stage and has set a target decision date of February 21, 2026.
Bysanti™, identified as an active metabolite of iloperidone, has been shown to be bioequivalent to its parent compound in clinical studies. These studies, which will be presented at the American Society of Clinical Psychopharmacology annual meeting later this month, support the efficacy and safety of Bysanti™ for treating bipolar I manic and mixed episodes, as well as schizophrenia. The drug’s safety profile is backed by data from thousands of patients exposed to iloperidone and over 80,000 patient-year exposures post-marketing.
The company is also exploring the potential for Bysanti™ as an adjunctive treatment for major depressive disorder (MDD) in patients who have not responded adequately to current treatments, with results expected in 2026. While currently not profitable, InvestingPro analysts project the company will return to profitability this year, with an EPS forecast of $0.90 for 2025. Additionally, Vanda is investigating the development of long-acting injectable formulations of milsaperidone due to its unique physical and chemical properties.
Bysanti™ is part of the atypical antipsychotic class and demonstrates strong affinity to the alpha 1 adrenergic receptor, along with certain serotonin and dopamine receptors. If approved, Bysanti™ could be commercially available in the U.S. in 2026 and may be eligible for 5 years of regulatory data exclusivity. The company’s related patent applications, if issued, could extend protection into the 2040s.
Dr. Mihael Polymeropoulos, President, CEO, and Chairman of the Board at Vanda, highlighted the significance of the bioequivalence discovery, which expedites the development of Bysanti™ and could lead to further therapeutic applications.
Vanda Pharmaceuticals is a global biopharmaceutical company focused on the development and commercialization of innovative therapies. With a current ratio of 4.39, the company maintains strong liquidity to support its development pipeline. As this information is based on a press release statement, the outcomes are subject to the FDA’s review process and the completion of ongoing clinical studies. For deeper insights into VNDA’s financial health and growth potential, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports and expert analysis covering 1,400+ US stocks.
In other recent news, Vanda Pharmaceuticals Inc. has announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for tradipitant, aimed at treating motion sickness, with a target decision date set for December 30, 2025. This follows the FDA’s delay in addressing Vanda’s request for a hearing regarding tradipitant’s approval for gastroparesis, a decision Vanda has criticized. Additionally, Vanda has submitted a New Drug Application for Bysanti™, targeting acute bipolar I disorder and schizophrenia, with expectations for market availability by 2026. In a separate development, H.C. Wainwright has reiterated its Buy rating for Vanda, maintaining a $20 price target, despite past challenges with the FDA. Vanda has also made strides in personalized medicine with the development of VCA-894A, an antisense oligonucleotide therapeutic for Charcot-Marie-Tooth disease Type 2S, which has received orphan designation from the FDA. This therapy represents a significant advancement in precision medicine, showing promise in improving neuromuscular function. These developments underscore Vanda’s ongoing efforts in expanding its therapeutic portfolio and addressing unmet medical needs.
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