VNDA biotech catalysts & pipeline

VANDA PHARMACEUTICALS INC · Data as of 2026-10-25

Upcoming catalysts

Bysanti (milsaperidone) — Initial data

Late 2026

BYSANTI TM is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year.

Source filing

NEREUS™ (tradipitant) — Clinical data readout

Late 2026

◦ NEREUS™ (tradipitant) in vomiting in GLP-1,

Source filing

HETLIOZ ® (tasimelteon) — FDA meeting

Dec 2026

The proceeding, a rare administrative hearing process granted after the D.C. Circuit set aside the FDA's prior refusal to approve the application, is advancing according to schedule and is expected to culminate in a five-day hearing before the Administrative Law Judge in December 2026.

Source filing

Quimilza TM (imsidolimab) — PDUFA

Dec 12

The Biologics License Application (BLA) for Quimilza TM in GPP is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.

Source filing

Bysanti (milsaperidone) — Clinical data readout

Q1 2027

The Phase III study of BYSANTI TM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027.

Source filing

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