as compared to the full year 2024.Key Operational Highlights – Regulatory & Clinical Development- On January 8, 2026, Vanda announced that it had received a decision letter from the FDA Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in the current form. This letter followed CDER's re-review of the jet lag sNDA under Vanda's collaborative framework agreement with th ...

Core Viewpoint - Vanda Pharmaceuticals Inc. has filed a New Drug Application (NDA) for Bysanti™ (milsaperidone) with the FDA, which has set a target decision date of February 21, 2026, with no review issues identified at this time [1] Group 1: Product Development - Bysanti™ is a new chemical entity identified as an active metabolite of iloperidone, showing bioequivalence to iloperidone in clinical studies at both low and high doses [2] - The efficacy and safety of Bysanti™ for bipolar I manic and mixed episodes and schizophrenia are supported by clinical studies related to iloperidone, including two studies in acute schizophrenia episodes and one in bipolar I disorder [4] - Bysanti™ is currently being studied as a once-a-day adjunctive treatment for major depressive disorder (MDD) in patients with inadequate response to current treatments, with results expected in 2026 [5] Group 2: Market Potential and Exclusivity - If approved, Bysanti™ could be available for sale in the U.S. in 2026 and is eligible for 5 years of regulatory data exclusivity [5] - Current patent applications related to Bysanti™ could extend exclusivity into the 2040s [5][8] Group 3: Mechanism of Action - Bysanti™ belongs to the class of atypical antipsychotics, interacting with various neurotransmitter receptors, including alpha-adrenergic, serotonin, and dopamine receptors, which are believed to explain its therapeutic effects [6][8] - The discovery of bioequivalence to iloperidone allows for efficient development and exploration of additional therapeutic applications for Bysanti™ [7]