NEREUS™ (tradipitant) — Clinical data readout
2026
◦ The Thetis Phase III study of NEREUS TM for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.Source filing
VNDA biotech catalysts & pipeline
VANDA PHARMACEUTICALS INC · Data as of 2026-10-27
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
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