FDA grants approval for Vanda Pharmaceuticals antipsychotic pill Bysanti

Vanda Pharma received FDA approval for its antipsychotic pill Bysanti today. The drug treats schizophrenia and bipolar disorder with a launch set for Q3.

Insights:
The U.S. Food and Drug Administration has approved the antipsychotic pill Bysanti (milsaperidone) from Vanda Pharmaceuticals Inc. for the treatment of schizophrenia and acute bipolar I disorder in the US USUS. The approval, which was announced on February 20, 2026, led to a roughly 30% rise in the company's shares during extended trading. This regulatory milestone marks a completed event that directly impacts Vanda's product lineup and its broader competitive positioning within the atypical antipsychotics / psychiatric drug market.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., on August 29, 2020. REUTERS/Andrew Kelly//File Photo
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., on August 29, 2020. REUTERS/Andrew Kelly//File Photo
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