Core Viewpoint - Vanda Pharmaceuticals Inc. will participate in the 2026 Citizens Life Sciences Conference, highlighting its commitment to addressing unmet medical needs through innovative therapies [1] Group 1: Conference Participation - The conference is scheduled for March 11, 2026, in Miami, with a corporate presentation at 2:15 p.m. Eastern Time [1] - Investors can access the live presentation on Vanda's corporate website and are advised to register at least 15 minutes early [1] - An archived version of the conference will be available on Vanda's website for approximately 30 days post-event [1] Group 2: Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on developing and commercializing innovative therapies [1] - The company aims to address high unmet medical needs and improve patient lives [1]

Core Viewpoint - Vanda Pharmaceuticals has announced the FDA's acceptance of the Biologics License Application for imsidolimab, targeting Generalized Pustular Psoriasis, with a decision expected by December 12, 2026 [1] Company Overview - Vanda Pharmaceuticals is focused on developing innovative therapies to meet high unmet medical needs, particularly in rare orphan diseases [1] - The company has a growing portfolio in anti-inflammatory treatments and rare orphan disorders [1] Product Details - Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling, aimed at treating Generalized Pustular Psoriasis (GPP) [1] - The drug has shown promising results in clinical studies, with 53% of patients achieving clear or almost clear skin at Week 4 compared to 13% on placebo [1] - Imsidolimab has a favorable safety profile, with a low incidence of anti-drug antibodies, which may provide an advantage over existing treatments [1] Market Potential - GPP is a rare and life-threatening disorder, with prevalence estimates ranging from approximately 2 to 124 cases per million worldwide [1] - If approved, imsidolimab will be Vanda's third new drug product approved in the past 12 months, following NEREUS™ and BYSANTI™ [1] Regulatory Milestone - The acceptance of the BLA filing for imsidolimab is celebrated during Rare Disease Week, highlighting the importance of innovation and access to treatments for rare diseases [1]

Core Viewpoint - Vanda Pharmaceuticals Inc. has received FDA approval for BYSANTI™ (milsaperidone), marking a significant advancement in the treatment of bipolar I disorder and schizophrenia, which could enhance the company's position in the psychiatric innovation sector [1] Company Summary - Vanda Pharmaceuticals Inc. shares experienced a sharp increase in pre-market trading following the announcement of FDA approval for BYSANTI™ [1]

Core Insights - Vanda Pharmaceuticals has received FDA approval for BYSANTI™ (milsaperidone), a new treatment for Bipolar I Disorder and Schizophrenia, marking a significant advancement in psychiatric care [1][2] Company Overview - Vanda Pharmaceuticals is a biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [2][3] - The approval of BYSANTI™ is the second new drug approval for Vanda within two months, following the approval of NEREUS™ in December 2025 [1] Product Details - BYSANTI™ is an atypical antipsychotic indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults [1][2] - The drug is a new chemical entity that shows bioequivalence to iloperidone, leveraging extensive clinical data and real-world experience [1] - BYSANTI™ is expected to be commercially available in Q3 of 2026, with patent protection extending until 2044 [1] Clinical Significance - Bipolar I disorder affects approximately 10 million Americans, while schizophrenia impacts about 2.8 million adults in the U.S., highlighting the need for effective treatments [1] - BYSANTI™ is currently being tested as a once-daily adjunctive treatment for treatment-resistant major depressive disorder [1] Safety and Efficacy - The safety profile of BYSANTI™ aligns closely with that of iloperidone, with a unique receptor binding profile that may allow for further investigation in related conditions [1] - Common adverse reactions include tachycardia, dizziness, and weight gain, with specific warnings for elderly patients and those with pre-existing conditions [2]