Vanda Pharmaceuticals Inc. develops and commercializes biopharmaceutical therapies, with company updates centered on prescription products and clinical or regulatory programs. Recurring news includes financial results, Fanapt sales trends, HETLIOZ commercialization, the U.S. availability of NEREUS (tradipitant) for prevention of vomiting induced by motion, and FDA approval of BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia.
Vanda news also covers development activity for imsidolimab in generalized pustular psoriasis, product-access and commercial-channel updates, investor conference participation, regulatory-policy statements, and corporate governance changes such as board appointments.
Vanda Pharmaceuticals (VNDA) will participate in five investor conferences in New York City and London during November 2026.
New York appearances include Wolfe Research on November 10, Stifel on November 11 and Truist Securities on November 12. London appearances include UBS on November 17 and Jefferies on November 19. The Stifel and Jefferies fireside chats will be webcast live through Vanda's website, with archives available for approximately 30 days.
Vanda Pharmaceuticals (VNDA) reported third-quarter 2026 revenue of $69.8 million, up 24% year over year and 38% sequentially. Sales included approximately $7.0 million of HETLIOZ orders shipped in June and delivered in July. Operating expenses fell 18% sequentially to $93.3 million but rose 7% year over year. Net loss was $22.6 million, versus $22.6 million a year earlier and $62.5 million in Q2.
Cash, cash equivalents and marketable securities totaled $140.5 million, down $123.4 million from year-end. Vanda expects full-year revenue above $240 million and a Q4 BYSANTI launch. It reported positive Phase III results for NEREUS in GLP-1-associated vomiting and HETLIOZ in Delayed Sleep-Wake Phase Disorder, with supplemental approval applications planned. Quimilza's application for Generalized Pustular Psoriasis remains under FDA review, with a December 12, 2026 target action date.
Vanda Pharmaceuticals (VNDA) reported Phase III results showing NEREUS reduced vomiting associated with semaglutide in randomized, placebo-controlled Study 3601. Any vomiting, the primary endpoint, occurred in 43.0% of treated participants versus 58.5% on placebo (p=0.006), a 27% relative reduction. Vomiting together with severe nausea occurred in 33.1% versus 50.6% (p=0.002), a 35% relative reduction.
Post hoc exploratory analyses found relative reductions of 60% in frequent multi-day vomiting and 81% in extreme vomiting. Participants received a single 1 mg semaglutide dose without the gradual titration used in clinical practice. No new safety signals were observed. Vanda plans FDA discussions and a supplemental New Drug Application seeking use of NEREUS for prevention of GLP-1 therapy-associated vomiting. NEREUS was approved in December 2025 for prevention of motion-induced vomiting.
Vanda Pharmaceuticals (Nasdaq: VNDA) will release its third-quarter 2026 financial results after the market closes on October 28, 2026. Management will discuss the results and other corporate activities on a 4:30 PM ET conference call that day. The call will be webcast simultaneously and archived on Vanda's website.
Vanda Pharmaceuticals (VNDA) reported that its Phase III VQW-765 study for on-demand treatment of acute anxiety in adults with social anxiety disorder missed its primary endpoint.
Study 3201 randomized 546 adults to a single oral dose of VQW-765 or placebo before a standardized stress test involving a presentation. The primary endpoint measured female participants' distress during the presentation on a 0–100 scale. Scores were 65.6 with VQW-765 versus 66.0 with placebo, with no statistically significant difference (p=0.8899). The key secondary endpoint in the combined male and female population also failed: scores were 64.7 versus 63.8 (p=0.6605). The results did not confirm earlier Phase II findings of numerically lower stress with VQW-765. VQW-765 was safe and well tolerated. The program is on hold pending further analysis of the full dataset.
Vanda Pharmaceuticals (VNDA) announced participation at the 2026 EADV Annual Meeting in Vienna, Austria, running September 30 through October 3, 2026. Three presentations concern imsidolimab in generalized pustular psoriasis (GPP), covering neutrophil measures, immunogenicity and pustulation results from the GEMINI-1 study. Imsidolimab is being developed for GPP.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that its Phase III HETLIOZ study met the primary endpoint in adults with Delayed Sleep-Wake Phase Disorder.
The disorder shifts the body's sleep clock later. Over 28 days, HETLIOZ 20 mg moved sleep onset 42.5 minutes earlier, versus 5.4 minutes with placebo, a 37.1-minute difference (p=0.022). Sleep diaries measured the endpoint, with 20 participants analyzed per arm. An exploratory analysis found that 60% receiving HETLIOZ advanced sleep onset by at least 30 minutes, versus 15% on placebo (p=0.008). The trial enrolled 43 patients across 26 US and European sites over more than five years. No new safety signals were identified during the controlled period.
Vanda plans to discuss the data with the FDA and submit a supplemental New Drug Application seeking approval for this disorder. HETLIOZ is not currently approved for this use.
Vanda Pharmaceuticals (VNDA) will participate in four investor conferences in September 2026, including events hosted by Wells Fargo, Cantor, H.C. Wainwright and Morgan Stanley.
Corporate presentations at the Cantor and H.C. Wainwright conferences will be webcast live and archived for about 30 days on Vanda's website.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported that the European Commission has granted Orphan Designation to its investigational drug imsidolimab for treating Generalized Pustular Psoriasis (GPP), following a positive opinion from EMA’s Committee for Orphan Medicinal Products.
According to Vanda, this is the first orphan designation in the EU for a GPP treatment. Imsidolimab already holds orphan status in the United States and Japan. EU orphan designation can provide protocol assistance, reduced regulatory fees and post‑approval market exclusivity. Vanda added that an imsidolimab BLA for GPP is under FDA review with a target action date of December 12, 2026.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that its NEREUS™ branded No. 47 IndyCar, fielded by Rahal Letterman Lanigan Racing and driven by Mick Schumacher, will compete in the inaugural Freedom 250 Grand Prix of Washington, D.C., held August 22–23, 2026 on the National Mall.
NEREUS™ (tradipitant), described by Vanda as the first new U.S. prescription medication in 47 years approved to prevent motion-induced vomiting, is the primary sponsor of the No. 47 Honda. The race weekend serves as a home event for the Washington-based company and will be broadcast live on FOX.