Vanda posts Q3 2026 results, cites NEREUS and HETLIOZ Phase III wins
Vanda reported positive Phase III data for NEREUS in GLP-1-induced vomiting and for HETLIOZ in sleep-wake disorder, alongside a pending Quimilza FDA decision and a Q4 BYSANTI launch.
Vanda Pharmaceuticals reported third quarter 2026 financial results on October 28, 2026. In October 2026, the company announced positive results from the Phase III clinical study "VP-VLY-686-3601" of NEREUS for the prevention of vomiting associated with GLP-1 receptor agonist therapy, and said it plans to discuss the results with the FDA and submit a supplemental New Drug Application seeking approval for that use.1
Separately, in September 2026 Vanda announced positive topline data from its pivotal Phase III study of HETLIOZ in adults with Delayed Sleep-Wake Phase Disorder, and plans to discuss the data with the FDA and submit an sNDA; if approved, the company said HETLIOZ would be the first FDA-approved medicine for this condition.1
On the regulatory front, the Quimilza BLA for generalized pustular psoriasis remains under FDA review, with a PDUFA target action date of December 12, 2026, following publication of the pivotal study results in the April 28, 2026 issue of NEJM Evidence.1 BYSANTI received FDA approval for bipolar I disorder and schizophrenia in the first quarter of 2026 and is expected to launch in the fourth quarter of 2026.1
A Phase III study of BYSANTI for major depressive disorder continues, with results expected in the first half of 2027 and enrollment at 55% of a 500-patient target across 54 U.S. and European sites.1
On legal matters, Vanda's FDA formal hearing on HETLIOZ for jet lag disorder is proceeding on schedule, with a five-day hearing set for December 14-18, 2026.1 Its court challenge over HETLIOZ for insomnia is awaiting a decision from the D.C. Circuit following September 2026 oral argument,1 while briefing in its NEREUS gastroparesis case is due to be completed in mid-November.1
Financially, cash, cash equivalents and marketable securities totaled $140.5 million as of September 30, 2026, a quarterly decrease of $29.5 million.1 Vanda updated its 2026 guidance to expect total revenue above $240 million for the full year.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.