TLDR
- FDA approved BYSANTI (milsaperidone) for Bipolar I manic episodes and Schizophrenia in adults
- VNDA stock jumped up to 44% after-hours on the news
- Patent protection runs to 2044, blocking generic competition for nearly two decades
- Second FDA approval for Vanda in under two months, following NEREUS in December 2025
- BYSANTI launch expected by Q3 2026, with depression trial data due by end of 2026
Vanda Pharmaceuticals just landed its second FDA approval in less than two months, and the stock reacted fast.
Vanda Pharmaceuticals Inc., VNDA
The FDA cleared BYSANTI — generic name milsaperidone — for Bipolar I manic episodes and Schizophrenia in adults. VNDA shot up as much as 44% after-hours on the news.
The December 2025 approval of NEREUS was the first. BYSANTI is the follow-up. Two approvals in two months is a rare run for any small-cap biotech.
BYSANTI carries a New Chemical Entity classification, which comes with some of the strongest patent protections available. Vanda’s patent on the drug runs to 2044 — nearly 20 years of generic-free runway.
Why BYSANTI Got Approved Faster Than Most
The FDA process moved quickly because BYSANTI is closely related to iloperidone, sold as Fanapt. Milsaperidone converts to iloperidone in the body and shows comparable drug levels and safety data.
That connection gave Vanda access to over 100,000 patient-years of real-world evidence — a significant head start that most new drugs don’t have.
The drug works by targeting dopamine and serotonin pathways. Its strong alpha-adrenergic binding may make it a preferred option for patients dealing with acute agitation and hostility, giving it a specific clinical edge.
Launch Timeline and What’s Next
BYSANTI is expected to hit the market by Q3 2026. Pricing and commercial partners have not been disclosed.
Vanda is also running trials using BYSANTI as a once-daily add-on treatment for major depressive disorder. Results are due by the end of 2026. A positive outcome would push the drug into one of the largest treatment markets in the world.
Analyst Outlook
Before this announcement, consensus on VNDA sat at “Sell” or “Flat.” That may shift as analysts reassess a pipeline that now includes two freshly approved drugs and an active depression trial.
VNDA was up 38% after-hours at last check, with a confirmed Q3 2026 launch on the calendar.
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