Shares of Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) surged 38% in after-hours trading Friday following the U.S. Food and Drug Administration’s approval of BYSANTI™ (milsaperidone) tablets, a fresh treatment for schizophrenia and bipolar I disorder, the company announced.
The FDA granted approval for BYSANTI™ as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults, according to a press release issued by Vanda Pharmaceuticals. The company anticipates launching the drug by the third quarter of 2026.
BYSANTI™ is a new chemical entity (NCE) classified as an atypical antipsychotic. Clinical studies demonstrated that milsaperidone, the active ingredient in BYSANTI™, is bioequivalent to iloperidone across various therapeutic dosages. This allows the new drug to leverage existing knowledge regarding the efficacy and safety of iloperidone, which has been supported by a substantial clinical development program and real-world experience with over 100,000 patients treated with Fanapt® (iloperidone), Vanda Pharmaceuticals stated.
“The BYSANTI™ approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage,” said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals.
Vanda Pharmaceuticals is also currently evaluating BYSANTI™ as a once-daily adjunctive treatment for treatment-resistant major depressive disorder in an ongoing clinical trial, with results expected by the end of 2026. The drug functions by rapidly converting to iloperidone, providing a dual-action effect through the antagonism of dopamine D2, serotonin 5-HT2A, and alpha1-adrenergic receptors, modulating key pathways involved in these disorders. The safety profile of BYSANTI™ closely mirrors that of iloperidone.
