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Home › FDA Decisions › VNDA 2026-02-21

VNDA FDA Decision Approved · 2026-02-21

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/21/26$8.82$4.329/5/25
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 2/21/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-21
DrugBysanti (milsaperidone)
IndicationBipolar I disorder / Schizophrenia
Outcome✓ Approvedprimary-sourced
Decision-day move+41.5%
T-120 run-up (low→high)+65.0% ($4.32→$8.82)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA220358, action date 2026-02-20
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was Bysanti (milsaperidone) approved by the FDA?

Yes. The FDA approved the application for Bysanti (milsaperidone) on February 21, 2026. The primary source is linked on this page.

What was Bysanti (milsaperidone) under FDA review for?

The application covered Bipolar I disorder / Schizophrenia. The FDA approved the application on February 21, 2026.

How did VNDA stock react to the FDA decision?

On the decision day VNDA moved +41.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.