Vanda reports Q2 2026 results, reaffirms guidance and three Phase III readouts by year-end

Vanda Pharmaceuticals reported second quarter 2026 results on August 5, 2026, with several pipeline and regulatory updates alongside its financial figures.

The company said BYSANTI received FDA approval for the treatment of bipolar I disorder and schizophrenia in the first quarter of 2026 and is expected to launch in the second half of 2026¹. Separately, the Biologics License Application for Quimilza in Generalized Pustular Psoriasis is under FDA review, with a PDUFA target action date of December 12, 2026¹.

Vanda said its late-stage studies of NEREUS for prevention of vomiting in patients on GLP-1 receptor agonist therapies, VQW-765 in social anxiety disorder, and HETLIOZ in delayed sleep phase disorder are all expected to produce results in 2026¹, while a Phase III study of BYSANTI as an adjunctive treatment for major depressive disorder is expected to report in the first half of 2027¹.

On the regulatory side, Vanda said the FDA granted Rare Pediatric Disease Designation to VCA-894A, an investigational antisense oligonucleotide for Charcot-Marie-Tooth disease, axonal, type 2S¹. The company also said its long-running dispute over HETLIOZ for jet lag disorder continues, noting that the FDA formal hearing process, granted after the D.C. Circuit vacated the agency's earlier rejection of the application, remains on schedule and is expected to reach a five-day hearing before an Administrative Law Judge in December 2026¹.

On finances, Fanapt net product sales increased 23% to $36.0 million in the quarter, with total prescriptions up 31%¹. Vanda said cash, cash equivalents and marketable securities totaled $170.0 million as of June 30, 2026¹, and reiterated that full-year 2026 total revenue guidance stands at $240 million to $290 million¹, with current cash and anticipated revenues expected to fund operations through at least the end of 2027¹.