Vanda Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 203
- Market Cap
- $311.8M
- 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.
Biopharma Q1 Updates: New Drug Launches and FDA Extension for Cytokinetics' Aficamten
• Neurocrine Biosciences, Madrigal Pharmaceuticals, and Vanda Therapeutics provided investors with key updates on their recent drug launches during Q1 earnings calls.
• Cytokinetics announced an FDA review extension for aficamten, their investigational cardiac myosin inhibitor, potentially impacting their timeline for market entry.
• The Q1 earnings season highlights significant catalysts across the biopharma sector as companies navigate regulatory pathways and initial commercialization challenges.
Eli Lilly Commits $250 Million to Expand Purdue University Research Alliance Through 2032
• Eli Lilly has extended its research collaboration with Purdue University through 2032, investing up to $250 million over the next eight years in what could become the largest industry-academic partnership in the United States.
• The expanded alliance will facilitate researcher exchanges between Purdue's campus and Lilly's Indianapolis facilities, while also utilizing Indiana's LEAP Research and Innovation District to accelerate drug discovery and development.
• This partnership represents a significant investment in pharmaceutical innovation infrastructure, focusing on improving both drug discovery processes and manufacturing capabilities in the U.S.
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.
• Stealth BioTherapeutics' treatment for rare Barth syndrome, elamipretide, has experienced an unexplained decision delay, with no typical safety or manufacturing concerns cited as reasons for the postponement.
• Industry experts warn that while widespread disruption isn't yet evident, continued FDA resource constraints could significantly impact clinical trial oversight and create approval backlogs lasting years.
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.
• Elamipretide aims to become the first approved treatment for Barth syndrome, an ultra-rare condition affecting approximately 150 people in the U.S. that causes muscle weakness, heart failure, and often early death.
• The delay comes amid thousands of FDA layoffs, raising concerns about the agency's capacity to meet drug review timelines despite assurances that drug reviewers would not be affected.
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.
• The company alleges FDA bureaucrats have systematically avoided scrutiny by denying all new drug approvability hearing requests for at least a decade, calling for Commissioner Makary to intervene.
• The dispute centers on tradipitant for gastroparesis, which the FDA rejected in September 2024, claiming the drug failed to demonstrate statistically significant treatment effects.
FDA Workforce Cuts Lead to Historic Drop in Medical Device Approvals
• FDA approvals for high-risk medical devices fell to a ten-year low in Q1 2025, with only nine approvals despite an increase in pending applications.
• More than 220 jobs were eliminated from the FDA's Center for Devices and Radiological Health in February, followed by additional cuts in April that affected approximately 10,000 HHS employees.
• Industry leaders, including Medical Alley Association, have expressed concerns that the loss of experienced personnel will delay approvals, slow progress, and potentially undermine public trust in critical health infrastructure.
Next-Generation Gene Therapies: Evolving Beyond Viral Vectors Towards More Affordable, Sustainable Solutions
• Despite 32 approved gene therapies globally, the industry faces significant challenges in safety, efficacy, and affordability, prompting development of novel delivery systems beyond traditional viral vectors.
• Companies are advancing non-viral delivery platforms including exosomes, lipid nanoparticles, and hydrophilic nanoparticles that offer cost-effective alternatives with reduced immunogenicity and potential for repeat dosing.
• Next-generation gene editing technologies like Prime Editing and CRISPR variants are emerging as more precise alternatives to traditional CRISPR-Cas9, with Prime Medicine's PM359 for chronic granulomatous disease advancing to clinical trials.
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.
• Bysanti is a novel atypical antipsychotic that works by interacting with multiple neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain.
• If approved, Bysanti could reach the US market by 2026, with potential patent exclusivity extending into the 2040s, while Phase III trials for its use in major depressive disorder are currently underway.
Bipolar Depression Market Set to Grow Through 2034 with New Therapies in Pipeline
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions.
• Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector.
• Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
Biotech Deal Landscape: February-March 2025 Sees Surge in Partnerships Across Multiple Therapeutic Areas
• The first quarter of 2025 witnessed significant biotech partnership activity, with Eli Lilly, AstraZeneca, and Novo Nordisk emerging as top collaborators in deals worth billions across small molecules, antibodies, and RNA therapeutics.
• February 2025 featured notable acquisitions including Novartis's $2.15 billion buyout of Anthos Therapeutics, while March saw AstraZeneca acquire Belgian biotech EsoBiotec and Bristol Myers Squibb purchase 2seventy bio for $286 million.
• Obesity therapeutics gained significant traction in March 2025, with AbbVie entering the field through a $350 million upfront deal with Gubra for an amylin analog, while Roche partnered with Zealand Pharma on petrelintide in a deal worth up to $5.25 billion.
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.
• The rejection highlights the FDA's strict requirement for well-controlled clinical trials in demonstrating drug efficacy for new indications.
• The decision marks a significant setback for expanding Hetlioz's therapeutic applications beyond its current approved uses.
Major Pipeline Expansion in Schizophrenia Treatment: 55+ Companies Developing 60+ Novel Therapies
• DelveInsight's latest pipeline report reveals over 55 pharmaceutical companies actively developing 60+ innovative drug candidates for schizophrenia treatment, indicating significant industry investment in addressing this serious mental illness.
• Several promising candidates are advancing in clinical trials, including Lyndra's weekly oral risperidone (LYN-005), AbbVie's selective M4 receptor PAM emraclidine, and Kynexis's cognitive function-targeting KYN-5356.
• Multiple clinical trials are scheduled for early 2025, including LB-102 for acute schizophrenia, Click Therapeutics' digital therapeutics, and Cerevel's emraclidine safety study, demonstrating diverse therapeutic approaches.
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.
• Phase 3 clinical trials demonstrated significant efficacy, with over 50% of patients achieving clear or almost clear skin after a single 750mg IV dose of imsidolimab compared to 13% on placebo.
• The companies plan to submit BLA and MAA applications in 2025, potentially offering a new treatment option for generalized pustular psoriasis, a life-threatening skin condition.
Novo Nordisk's Amycretin Shows Promising Weight Loss in Phase 1b/2a Trial
• Novo Nordisk's amycretin, a GLP-1 and amylin receptor agonist, demonstrated significant weight loss in a Phase 1b/2a trial.
• Participants on the highest dose of subcutaneous amycretin (20mg) experienced an average 22% body weight loss over 36 weeks.
• The safety profile of amycretin was consistent with incretin-based therapies, with mainly mild to moderate gastrointestinal adverse events.
• Novo Nordisk plans further clinical development of amycretin for adults with overweight or obesity, based on these encouraging results.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
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.
• Vanda disputes the FDA's assessment, asserting that tradipitant has demonstrated substantial evidence of efficacy and a favorable benefit-risk profile in clinical studies.
• Vanda has formally accepted the FDA's offer for a hearing to discuss the tradipitant NDA, aiming to address the concerns raised by the agency and advocate for approval.
• The D.C. Circuit Court of Appeals upheld the FDA's denial of fast-track approval for tradipitant, supporting the agency's right to consider the drug's development plan.
BioAge Labs Halts Azelaprag Trial Due to Safety Concerns, Faces Investor Scrutiny
• BioAge Labs discontinued its Phase 2 STRIDES trial of azelaprag for obesity treatment after observing elevated liver enzymes in participants.
• The trial's halt led to a significant drop in BioAge's stock price, prompting investor concern and a formal investigation by Hagens Berman.
• BioAge is now facing a class-action lawsuit alleging misleading statements about azelaprag's safety profile prior to the company's IPO.
• Despite the setback, BioAge plans to advance other programs, including NLRP3 inhibitors for central nervous system targets, and is working on new drugs targeting azelaprag’s original target.
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