Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Announces Positive Results from Study 3601 of NEREUS™ (tradipitant) for Prevention of GLP-1-Induced Vomiting

Vanda Pharmaceuticals reported positive Phase III results from Study 3601 showing NEREUS (tradipitant) significantly reduced GLP-1 (semaglutide)-induced vomiting, meeting the primary endpoint with a 27% relative reduction (p=0.006). Higher-burden outcomes showed even larger effects: 60% relative reduction in frequent multi-day vomiting and 81% reduction in extreme vomiting versus placebo, with no new safety signals. Vanda plans to meet with the FDA and file an sNDA to add GLP-1-induced vomiting prevention to NEREUS's existing approval, positioning the drug against a >$50 billion and growing GLP-1 market where GI side effects drive roughly half of patients to discontinue therapy within a year.

•5d ago

Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder

Vanda Pharmaceuticals reported positive topline Phase III results for HETLIOZ (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder, with the study meeting its primary endpoint. Tasimelteon shifted sleep onset 42.5 minutes earlier versus 5.4 minutes on placebo — a 37.1-minute difference (p=0.022) — and 60% of treated patients advanced sleep onset by at least 30 minutes versus 15% on placebo, with no new safety signals. Vanda plans to discuss the data with the FDA and file an sNDA; if approved, HETLIOZ would be the first FDA-approved medicine for DSWPD, extending an already-commercialized drug into a third indication affecting an estimated 0.5 to 4.1 million US adults.

•1mo ago

Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission

Vanda Pharmaceuticals received Orphan Drug Designation from the European Commission for imsidolimab to treat Generalized Pustular Psoriasis. This designation marks the first time a drug for GPP has received such recognition in the EU, granting potential market exclusivity and fee reductions. The company noted that the FDA is currently reviewing the Biologics License Application for imsidolimab with a target action date of December 12, 2026.

•2mo ago

Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe

Vanda Pharmaceuticals received a positive opinion from the EMA's Committee for Orphan Medicinal Products for orphan drug designation of imsidolimab for Generalized Pustular Psoriasis. This designation marks the first recognition of GPP as a distinct orphan disease in the EU, conferring benefits such as protocol assistance and market exclusivity upon approval. The company noted that the FDA is currently reviewing the Biologics License Application for imsidolimab with a target action date of December 12, 2026.

•3mo ago

NEREUS™ Powers Forward: Sponsors No. 47 IndyCar Entry, Celebrating 47 Years Since Last New U.S. Motion Sickness Treatment

Vanda Pharmaceuticals announced a marketing partnership with Rahal Letterman Lanigan Racing, sponsoring the No. 47 entry in the NTT IndyCar Series to promote NEREUS (tradipitant). The campaign highlights NEREUS as the first new prescription medication approved for motion sickness-induced vomiting in the U.S. in 47 years. The branded car will feature the NEREUS logo at select IndyCar events in 2026 to drive brand awareness for the NK-1 receptor antagonist.

•3mo ago

Vanda Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Investigational Therapy for Charcot-Marie-Tooth Disease Type 2S

Vanda Pharmaceuticals received Rare Pediatric Disease Designation from the FDA for VCA-894A, an investigational antisense oligonucleotide therapy designed to treat Charcot-Marie-Tooth disease type 2S. The designation applies to a serious and progressive neuromuscular disorder that primarily affects individuals from birth through age 18 and has an estimated prevalence of less than 1 in 1,000,000 worldwide. Under the FDA's program, this designation makes Vanda potentially eligible to receive a Priority Review Voucher upon approval of a marketing application for VCA-894A.

•3mo ago

Vanda Pharmaceuticals Announces Orphan Drug Designation in Japan for Imsidolimab in Generalized Pustular Psoriasis

Vanda Pharmaceuticals announced that Japan's Ministry of Health, Labour and Welfare granted orphan drug designation to imsidolimab for generalized pustular psoriasis (GPP). The designation unlocks development incentives in Japan, including R&D subsidies and the potential for up to 10 years of market exclusivity following approval. This follows similar regulatory recognition in the United States, reinforcing the global potential of imsidolimab to address unmet medical needs in this rare and severe inflammatory skin disease.

•5mo ago

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

Vanda Pharmaceuticals reported Q1 2026 total net product sales of $51.7 million, a 3% increase year-over-year, driven by a 26% surge in Fanapt sales to $29.6 million. The company raised its full-year 2026 revenue guidance to $240-$290 million from $230-$260 million to include the newly launched NEREUS product, which is available via a direct-to-consumer platform. BYSANTI (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia, and the FDA accepted the BLA for imsidolimab with a PDUFA date of December 12, 2026.

•5mo ago

Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Vanda Pharmaceuticals announced the U.S. commercial availability of NEREUS (tradipitant) for the prevention of motion sickness, marking the first new prescription treatment for this condition in over 40 years. The drug is available via a direct-to-consumer platform and retail pharmacies, with a cash-pay price of $85 per dose compared to a standard list price of $255. The FDA approved NEREUS on December 30, 2025, based on two pivotal Phase 3 trials that demonstrated significant prevention of vomiting in real-world sea travel conditions.

•5mo ago

Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Vanda Pharmaceuticals announced the U.S. commercial availability of NEREUS (tradipitant), the first new prescription medicine for motion sickness in over 40 years. The drug targets a large patient population of 65 to 78 million Americans and is available through a direct-to-consumer portal at a cash-pay price of $85 per dose. NEREUS is an NK-1 receptor antagonist approved by the FDA in December 2025 and is currently in development for other indications including gastroparesis and GLP-1-induced nausea.

•6mo ago

Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence

Partner Vanda Pharmaceuticals published the original research article titled "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence. The findings from this pivotal Phase 3 study are included in the Biologics License Application submitted to the FDA, which has a target action date of December 12, 2026. AnaptysBio holds the exclusive global license for imsidolimab and stands to benefit from the drug's validation and potential approval later this year.

•6mo ago