Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Bysanti (milsaperidone) was approved by the FDA on February 20, 2026 to treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder, the 3rd novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Vanda Pharmaceuticals Inc., Bysanti (milsaperidone) · Acute bipolar I disorder.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (9/5/25) through T+5. Run-up high $8.82 on 1/5/26, low $4.32 on 11/6/25 (T-120 to T-1). FDA decision 2/20/26. Historical price action, not a forecast.
FDA record of the action: the FDA approved on February 20, 2026, per NDA 220358 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Bysanti (milsaperidone) approved by the FDA?
Yes. The FDA approved the application for Bysanti (milsaperidone) on February 20, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Bysanti (milsaperidone)?
Bysanti (milsaperidone) is a Vanda Pharmaceuticals Inc. (VNDA) program. The FDA decision came on February 20, 2026; the FDA's own record of the decision is linked on this page.
How did VNDA stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), VNDA moved +29.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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