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) 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.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported Q2 2026 total net product sales of $50.5 million, down 4% year-over-year, with Fanapt® up 23% to $36.0 million, PONVORY® up 12% to $7.9 million and HETLIOZ® down 66% to $5.6 million, excluding about $7.0 million of HETLIOZ® revenue expected to be recognized in Q3 2026.
NEREUS™ generated $1.0 million in its Q2 2026 U.S. launch quarter. Q2 loss before income taxes widened to $62.4 million, with net loss at $62.5 million. Cash, cash equivalents and marketable securities totaled $170.0 million at June 30, 2026; Vanda expects this, plus anticipated revenues, to fund operations through at least year-end 2027.
According to Vanda, BYSANTI™ received FDA approval in Q1 2026 with launch planned for H2 2026, Quimilza™ has a PDUFA target date of December 12, 2026, NEREUS™ became commercially available in Q2, and multiple Phase III readouts are expected in 2026–early 2027. Full-year 2026 total revenue guidance is $240–$290 million.
Vanda Pharmaceuticals (Nasdaq: VNDA) will release its second quarter 2026 financial results on Wednesday, August 5, 2026, after the market close. Management will host a conference call and webcast at 4:30 PM ET the same day to review results and discuss corporate activities.
Investors can join by phone using domestic number 1-888-596-4144 or international number 1-646-968-2525 with passcode 1843107, or via webcast on Vanda's website. A replay will be available from 8:30 PM ET on August 5 until 11:59 PM ET on August 12, 2026, at 1-800-770-2030 (domestic) or 1-609-800-9909 (international), using the same passcode.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported that the Committee for Orphan Medicinal Products at the European Medicines Agency adopted a positive opinion recommending orphan drug designation for imsidolimab, a high-affinity humanized IgG4 monoclonal antibody, for treating generalized pustular psoriasis (GPP).
According to Vanda, this is the first time the EMA has provided orphan drug designation recognition for a GPP treatment in the EU. Orphan status in Europe offers protocol assistance, reduced regulatory fees and market exclusivity after approval. The opinion follows similar regulatory recognitions in the US and Japan, and Vanda’s imsidolimab BLA for GPP is under FDA review with a target action date of December 12, 2026.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that NEREUS™ (tradipitant), described as the first new U.S. prescription treatment in 47 years for prevention of vomiting induced by motion, will sponsor the No. 47 Rahal Letterman Lanigan Racing entry in the NTT IndyCar Series. The 2026 partnership highlights NEREUS™ as a selective NK-1 receptor antagonist and will feature prominent NEREUS™ branding on the No. 47 IndyCar at select series events.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced it will participate in a fireside chat at the B. Riley Securities Mind, Muscle & Vision Summit in Boston, Massachusetts. The appearance is scheduled for Thursday, July 16, 2026, as part of the summit program.