TLDR
- FDA approved BYSANTI (milsaperidone) to treat Bipolar I manic episodes and Schizophrenia in adults
- VNDA stock climbed as much as 44% after-hours following the announcement
- Patent on BYSANTI extends to 2044, keeping generic rivals out for close to two decades
- Marks Vanda’s second FDA approval in under two months, after NEREUS was cleared in December 2025
- Commercial launch targeted for Q3 2026, with depression study results expected before year-end
Vanda Pharmaceuticals picked up its second FDA approval in less than two months, and investors didn’t wait around.
Vanda Pharmaceuticals Inc., VNDA
BYSANTI — the brand name for milsaperidone — was cleared by the FDA for Bipolar I manic episodes and Schizophrenia in adults. VNDA climbed as much as 44% after-hours on the back of the news.
The first approval, NEREUS, came in December 2025. BYSANTI is the second. Two approvals in such a short window is uncommon territory for a small-cap biotech.
BYSANTI was granted New Chemical Entity status, one of the stronger patent designations available. Vanda’s protection on the drug runs all the way to 2044 — nearly 20 years before a generic competitor can enter the picture.
How BYSANTI Moved Through the FDA So Quickly
Speed was possible here because BYSANTI has a direct link to iloperidone, the active ingredient in the already-approved drug Fanapt. Milsaperidone converts to iloperidone in the body and produces comparable drug levels and safety outcomes.
That gave Vanda a shortcut most drug developers don’t get — access to more than 100,000 patient-years of existing real-world data to support its case.
The drug targets dopamine and serotonin pathways, consistent with other antipsychotics. Its strong alpha-adrenergic binding profile may set it apart for patients managing acute agitation and hostility.
Launch Plans and the Depression Trial
BYSANTI is on track to reach the market by Q3 2026. Vanda has not yet released pricing details or named any commercial partners.
Running alongside the launch prep is a separate trial testing BYSANTI as a once-daily add-on for major depressive disorder. Data from that study is expected by the end of 2026. A positive result would open the door to one of the biggest prescription drug markets in the world.
Where Analyst Sentiment Stands
Heading into this announcement, the consensus on VNDA was sitting at “Sell” or “Flat.” With two approvals now on the books and an active depression trial in progress, that view may be due for a revision.
VNDA was last seen up 38% after-hours, with the FDA approval confirmed and a Q3 2026 commercial launch locked in.
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