pdufa.bio
HomeDecisions › VNDA 2026-02-20

VNDA FDA decision — Feb 20, 2026

✓ APPROVED

Vanda Pharmaceuticals Inc. — Bysanti (milsaperidone) · Acute bipolar I disorder.

Run-up into the decision (T-120 → T+5)

PDUFA 2/20/26$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 2/20/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-20
OutcomeApproved
Drug / candidateBysanti (milsaperidone)
CompanyVanda Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+29.8%