Vanda Secures FDA Nod for Bysanti, Psoriasis Drug Eyes December 2026 Decision
FDA approved Bysanti for acute bipolar I and schizophrenia, targeting a Q3 2026 launch with exclusivity to 2044 after bioequivalence to iloperidone. FDA accepted the BLA for imsidolimab in generalized pustular psoriasis after trials showed 53% clearance versus 13% placebo at Week 4, with a PDUFA date of December 12, 2026.
1. Bysanti Receives FDA Approval
FDA approved Bysanti (milsaperidone) as a first-line oral treatment for acute manic or mixed episodes in adult bipolar I disorder and schizophrenia. The drug demonstrated bioequivalence to iloperidone and is slated for commercial launch in Q3 2026 with marketing exclusivity through 2044.
2. Imsidolimab BLA Accepted for Psoriasis
The FDA accepted Vanda’s Biologics License Application for imsidolimab to treat generalized pustular psoriasis, setting a PDUFA action date of December 12, 2026. In pivotal studies, a single intravenous dose delivered 53% skin clearance at Week 4 versus 13% with placebo, with sustained responses over two years.
3. Revenue Potential and Market Outlook
Bysanti’s approval builds on Fanapt’s $33.2 million in Q4 2025 sales (+25% YoY), expanding Vanda’s psychiatric portfolio. Analysts maintain Buy ratings with average targets near $18, reflecting upside from the new bipolar, schizophrenia and psoriasis franchises.