Vanda’s Phase 3 Trial of VQW-765 for Social Anxiety Disorder Fails to Meet Primary Endpoint
The program is now on hold.
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HETLIOZ Meets Phase III Endpoint in Delayed Sleep-Wake Phase Disorder; Vanda Plans FDA Filing
If approved, it would be the first FDA-approved medicine for the circadian disorder.
Vanda Pharmaceuticals Receives First EU Orphan Designation for Imsidolimab in Generalized Pustular Psoriasis
Vanda Pharmaceuticals receives the first EU orphan designation for imsidolimab to treat rare, life-threatening GPP. FDA decision due Dec 12, 2026.
FDA Grants Rare Pediatric Disease Designation to Vanda’s Investigational Therapy VCA-894A for Ultra-Rare CMT2S
The designation makes Vanda eligible for a Priority Review Voucher upon approval.
Japan Grants Orphan Drug Designation to Vanda’s Imsidolimab for Rare Skin Disease GPP
Vanda’s drug imsidolimab receives orphan drug status in Japan for the rare skin disease GPP, speeding up approval.
FDA Approves BYSANTI (Milsaperidone) for Bipolar I & Schizophrenia
Vanda Pharmaceuticals’ BYSANTI (milsaperidone) receives FDA approval as a new atypical antipsychotic for bipolar I manic/mixed episodes and schizophrenia in adults. Launch expected Q3 2026 with strong patent protection until 2044.