Total Revenue Growth and Raised Guidance
Q1 2026 total net product sales were $51.7M, up 3% year-over-year (Q1 2025: $50.0M). Vanda raised full-year 2026 revenue guidance to $240M–$290M (midpoint $265M), implying ~23% revenue growth vs full-year 2025.
Fanapt Commercial Momentum
Fanapt Q1 2026 net product sales were $29.6M, up 26% year-over-year (Q1 2025: $23.5M). Prescription metrics: TRx +32% YoY and NBRx +76% YoY. Weekly TRx reached an eleven‑year high of >2.6k for week ending 04/24/2026. Full-year Fanapt guidance $150M–$170M (midpoint implies ~36% growth vs 2025).
Nirius U.S. Launch and Innovative DTC Model
Nirius launched nationwide via a direct-to-consumer platform (nirius.us) with a cash-pay offering. Company introduced 2026 Nirius revenue guidance of $10M–$30M. WAC price set at $255 per capsule with cash-pay discounted to $85 (~65%+ discount). Described as first new prescription therapy for prevention of motion‑induced vomiting in adults in >40 years.
Regulatory and Pipeline Progress — Dysanti Approval
Dysanti (milsoperidone) received FDA approval for bipolar I disorder and schizophrenia; protected by data exclusivity through 02/20/2031 and patents through 05/31/2044. Company expects Dysanti commercial availability in back half of 2026.
Imsidolimab Regulatory Milestone and Publication
FDA accepted the BLA for imsidolimab in generalized pustular psoriasis with a PDUFA target action date of 12/12/2026. Pivotal study results were published in NEJM Evidence (04/28/2026). Company is preparing commercial/regulatory activities in US, Europe, and Japan.
Late‑Stage Clinical Readouts Expected
Several key Phase 3 timelines: Dysanti adjunctive MDD readout expected Q1 2027, a Phase 3 study of Nirius for GLP‑1 induced vomiting expected in 2026, and Phase 3 VQW‑765 (social anxiety) results expected by 2026 — signaling multiple upcoming value‑creating catalysts.
Commercial Infrastructure Expansion
Fanapt sales force expanded from ~160 reps (end 2024) to ~300 reps (end 2025). Face‑to‑face calls in Q1 2026 were >80% higher vs Q1 2025, supporting continued prescription growth.