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VNDA FDA Decision Approved · 2026-02-21

Page updated October 4, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

Price into the decision (T-120)

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action 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 company announced it 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.