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WASHINGTON - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), currently valued at $273.5 million, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Bysanti™, a medication aimed at treating acute bipolar I disorder and schizophrenia. The application, backed by multiple clinical trials, marks a significant step for the company in bringing this new atypical antipsychotic drug to market. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, suggesting potential upside for investors watching this development.
Bysanti™ operates by interacting with various neurotransmitter receptors in the brain, a method thought to underpin its therapeutic effects. These receptors include alpha-adrenergic, serotonin, and dopamine receptors. Vanda’s innovation could potentially offer a new option for patients if the FDA grants approval, which the company anticipates could allow Bysanti™ to be available for sale in the United States by 2026. The company maintains impressive gross profit margins of 94.3% and holds more cash than debt on its balance sheet, demonstrating strong financial fundamentals to support its drug development programs.
In addition to the NDA for bipolar and schizophrenia treatments, Vanda has initiated a Phase III clinical study of Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD). This study began in the last quarter of 2024, with results expected in 2026.
The company also projects that patent applications currently pending could secure exclusivity for Bysanti™ into the 2040s, potentially providing a long-term commercial edge.
Vanda Pharmaceuticals, a global biopharmaceutical firm, focuses on the development and commercialization of innovative therapies to address unmet medical needs and improve patient lives.
The press release includes forward-looking statements regarding Bysanti™’s mechanism of action, potential market availability, and the anticipated timing of clinical study results. These statements involve risks and uncertainties, and there is no guarantee that the anticipated outcomes will materialize. Investors are cautioned not to place undue reliance on these forward-looking statements, which are valid only as of the date of the press release.
This news article is based on a press release statement.
In other recent news, Vanda Pharmaceuticals reported its fourth-quarter and full-year 2024 financial results, revealing a top-line revenue of $52.3 million for the fourth quarter, surpassing the forecast of $49 million. The company’s net loss for 2024 was $0.33 per share, narrower than the anticipated $0.38 per share. H.C. Wainwright has subsequently increased its price target for Vanda Pharmaceuticals to $20.00, maintaining a Buy rating, and adjusted its 2025 top-line forecast to $225 million. In another development, the U.S. FDA has accepted Vanda’s New Drug Application for tradipitant, aimed at treating motion sickness, with a decision date set for December 30, 2025. Tradipitant has shown statistically significant results in preventing motion-induced vomiting in extensive studies. Additionally, Vanda announced the development of a novel antisense oligonucleotide therapy, VCA-894A, targeting Charcot-Marie-Tooth disease Type 2S, which has been granted orphan designation by the FDA. The company has also disclosed changes to its executive compensation, including adjustments to annual bonuses, base salaries, and the awarding of restricted stock units. These developments reflect Vanda Pharmaceuticals’ ongoing efforts in drug development and financial management.
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