Vanda Pharmaceuticals receives FDA approval for Bysanti (milsaperidone) for bipolar I disorder and schizophrenia

Vanda Pharmaceuticals Inc.

Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.
Bysanti is a new chemical entity that interconverts to iloperidone, leveraging 100,000+ patient-years of real-world experience.
Vanda expects commercial availability in Q3 2026; marketing exclusivity protected by patents expiring in 2044.
This is Vanda's second new drug approval in less than 2 months, following NEREUS in December 2025.
Bysanti is being tested as a once-daily adjunctive for treatment-resistant major depressive disorder, study completion expected by end of 2026.

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