MedPath

Vanda Pharmaceuticals

🇺🇸United States
Ownership
-
Employees
203
Market Cap
$311.8M
Website
Introduction

Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.

Vanda Pharmaceuticals Initiates First-in-Human Trial of Personalized ASO Therapy VCA-894A for Ultra-Rare CMT2S

Vanda Pharmaceuticals has dosed the first patient in a first-in-human clinical trial evaluating VCA-894A, an antisense oligonucleotide therapy designed for a specific patient with Charcot-Marie-Tooth disease Type 2S.

Vanda Pharmaceuticals Appeals to Supreme Court Over FDA's Fast-Track Denial for Gastroparesis Drug

Vanda Pharmaceuticals has petitioned the U.S. Supreme Court to overturn the FDA's decision denying fast-track approval for tradipitant, its gastroparesis treatment candidate.

FDA Budget Cuts Linked to Drug Approval Delays as Small Biotech Faces PDUFA Postponement

Recent government efficiency cuts at the FDA appear to be causing delays in drug approval timelines, with 66% of healthcare professionals surveyed expressing concern about potential PDUFA date postponements.

FDA Misses Deadline for Stealth Biotherapeutics' Rare Barth Syndrome Drug Elamipretide

The FDA has missed its April 29 deadline to decide on Stealth Biotherapeutics' elamipretide for Barth syndrome, with no new decision date announced yet.

Vanda Pharmaceuticals Battles FDA Over Gastroparesis Drug Hearing Delays

Vanda Pharmaceuticals has accused FDA officials of unlawfully delaying a hearing on its gastroparesis drug tradipitant, claiming the agency is using recent staff reductions as a false excuse for a six-month postponement.

Vanda Pharmaceuticals Submits NDA for Novel Antipsychotic Bysanti to Treat Bipolar I Disorder and Schizophrenia

Vanda Pharmaceuticals has submitted a New Drug Application to the FDA for Bysanti (milsaperidone), seeking approval for the treatment of acute bipolar I disorder and schizophrenia.

FDA Rejects Vanda's Hetlioz Application for Insomnia Treatment Due to Insufficient Trial Data

FDA Acting Commissioner Sara Brenner has denied Vanda Pharmaceuticals' request for a hearing on Hetlioz (tasimelteon) for sleep-onset insomnia, citing lack of adequate trial data.

Vanda Acquires Global Rights to Imsidolimab for GPP in $50 Million Deal with AnaptysBio

Vanda Pharmaceuticals secures exclusive global licensing rights to imsidolimab from AnaptysBio in a deal worth up to $50 million, including $15 million upfront payment and potential milestone rewards.

Vanda Pharmaceuticals' VGT-1849A, a Selective JAK2 Inhibitor, Receives FDA Orphan Drug Designation for Polycythemia Vera

The FDA has granted Orphan Drug Designation to VGT-1849A, a selective antisense oligonucleotide JAK2 inhibitor, for treating polycythemia vera (PV).

Vanda Pharmaceuticals Challenges FDA Rejection of Tradipitant for Gastroparesis, Seeks Hearing

The FDA issued a Complete Response Letter for Vanda Pharmaceuticals' tradipitant, a neurokinin-1 receptor antagonist, for treating gastroparesis, citing insufficient evidence of efficacy.

© Copyright 2025. All Rights Reserved by MedPath