Vanda Pharmaceuticals Inc.

VNDA

Held by 1 specialist biotech fund

1 fund opened new positions. Next phase3 readout (Tradipitant): Aug 2020. Short interest: 12.2% of float.

BiotechnologyCEO: Mihael H. PolymeropoulosIPO: 2006Website ↗

Vanda Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of therapies to address high unmet medical needs. The company's marketed products include HETLIOZ for the treatment of non-24-hour sleep-wake disorders; and Fanapt oral tablets for the treatment of schizophrenia. Its products under development include HETLIOZ (tasimelteon) for the treatment of jet lag disorder, smith-magenis syndrome, pediatric Non-24, autism spectrum, and delayed sleep phase disorder; Fanapt (iloperidone) for the treatment of bipolar disorder and a long acting injectable formulation program for the treatment of schizophrenia; and Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, for the treatment of atopic dermatitis, gastroparesis, and motion sickness. The company's products under development also comprise VTR-297, a small molecule histone deacetylase inhibitor for the treatment of hematologic malignancies and with potential use as a treatment for various oncology indications; VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist for the treatment of psychiatric disorders; a portfolio of cystic fibrosis transmembrane conductance regulator activators and inhibitors for the treatment of dry eye and ocular inflammation, as well as BPO-27 for the treatment of secretory diarrhea disorders, including cholera; and VHX-896, the active metabolite of iloperidone. It markets its products in the United States, Europe, and Israel. Vanda Pharmaceuticals Inc. was incorporated in 2002 and is headquartered in Washington, the District of Columbia.

Catalysts

Phase 2PositiveQ1 2005VEC-162Circadian Rhythm Sleep DisordersNCT00490945

Primary: Circadian Phase Shift (Night 3 and Night 4)Enrollment:45/45Sites: 2RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 200620 mg VEC-162InsomniaNCT00291187

Primary: Average Improvement of Latency to Persistent Sleep (LPS) (Night 1)Enrollment:411/411Sites: 19RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2006IloperidoneSchizophreniaNCT00254202

Primary: Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score (4 weeks)Enrollment:593/593Sites: 42RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2008VEC-162 20 mgPrimary InsomniaNCT00548340

Primary: Average Change From Baseline - Latency to Persistent Sleep (LPS) (Baseline, Night 1, and Night 8 measurement)Enrollment:322/322Sites: 35RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ4 2012tasimelteonNon-24-Hour Sleep-Wake DisorderNCT01163032

Primary: Proportion of Patients Entrained as Assessed by Urinary aMT6 (1 month)Enrollment:136/136Sites: 28RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2012tasimelteonNon-24-Hour Sleep-Wake DisorderNCT01430754

Primary: Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD. (Approximately 12 weeks)Enrollment:20/20Sites: 22RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ1 2013tasimelteonMajor Depressive DisorderNCT01428661

Primary: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) (8 weeks)Enrollment:507/507Sites: 40RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2014IloperidoneSchizophreniaNCT01291511

Primary: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)Enrollment:635/635Sites: 63RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2015tasimelteonNon-24-Hour Sleep-Wake DisorderNCT01429116

Primary: Number of participants with Treatment-Emergent Adverse Events (AEs) (24 months + 12 month optional extension)Enrollment:Target 200Sites: 22NA, TREATMENT

Phase 2Q1 2015VLY-686Treatment-resistant Pruritus Associated With Atopic DermatitisNCT02004041

Primary: Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. (28 days)Enrollment:69/69Sites: 5RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2017TradipitantAtopic DermatitisNCT02651714

Primary: Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score (56 days)Enrollment:168/168Sites: 28RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ4 2017TasimelteonJet Lag DisorderNCT03291041

Primary: Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted (4 days)Enrollment:25/25Sites: 3RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 2018TasimelteonJet Lag Type InsomniaNCT03373201

Primary: Total Sleep Time in the First Two Thirds of the Night (1 Day)Enrollment:320/320Sites: 12RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2018tasimelteonSmith-Magenis Syndrome, CircadianNCT02231008

Primary: To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters (9 Weeks)Enrollment:49/49Sites: 4RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q4 2018VLY-686 (Tradipitant)GastroparesisNCT02970968

Primary: Change From Baseline in Average Nausea Severity (4 weeks)Enrollment:152/152Sites: 38RANDOMIZED, TRIPLE, TREATMENT

Phase 2PositiveQ2 2019TradipitantMotion SicknessNCT03772340

Primary: The Most Severe Motion Sickness Severity During Vehicle Travel (1 day)Enrollment:126/126Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ4 2019TradipitantAtopic DermatitisNCT03568331

Primary: Reduction of Worst Itch in Atopic Dermatitis (8 weeks)Enrollment:375/375Sites: 70RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2020TradipitantCoronavirus InfectionNCT04326426

Primary: Time to improvement on a 7-point ordinal scale as compared to baseline (14 days or discharge)Enrollment:Target 300Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ4 2020TradipitantAtopic DermatitisNCT04140695

Primary: Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 (2 weeks)Enrollment:87/87Sites: 51RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ1 2021ImsidolimabGeneralized Pustular PsoriasisNCT03619902

Phase 2PositiveQ2 2021ImsidolimabPalmoplantar PustulosisNCT03633396

Primary: Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) (Baseline to Week 16)Enrollment:59/59Sites: 39RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q2 2021VSJ-110Allergic ConjunctivitisNCT04622345

Primary: Ocular Itching as Measured by Self-reported Numerical Scales (16 hours, 8 hours, and 15 minutes post-treatment)Enrollment:47/47Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Phase 2PositiveQ3 2021TradipitantHealthy VolunteerNCT04849559

Primary: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) (9 Days)Enrollment:27/27Sites: 1RANDOMIZED, QUADRUPLE, BASIC_SCIENCE

Phase 2NegativeQ4 2021ImsidolimabIchthyosisNCT04697056

Phase 2NegativeQ4 2021ImsidolimabAcneiform EruptionsNCT04697069

Phase 2Q1 2022ImsidolimabAcne VulgarisNCT04856917

Primary: Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 (Baseline, Week 12)Enrollment:123/123Sites: 15RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2022ImsidolimabHidradenitis SuppurativaNCT04856930

Phase 2PositiveQ3 2022VQW-765Performance AnxietyNCT04800237

Phase 3Q3 2022IloperidoneBipolar I DisorderNCT04819776

Primary: Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score (Week 4)Enrollment:417/417Sites: 27RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ2 2023TradipitantMotion SicknessNCT04327661

Phase 3Q3 2023750 mg ImsidolimabGeneralized Pustular PsoriasisNCT05352893

Phase 2Q4 2023IloperidoneParkinson Disease PsychosisNCT05344365

Phase 3PositiveQ2 2024TradipitantMotion SicknessNCT05903924

Phase 3NegativeQ3 2024Double-blind 200 mg imsidolimabGeneralized Pustular PsoriasisNCT05366855

Phase 3Q2 2025TasimelteonSleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology DisordersNCT06701396

Phase 2Q4 2025TradipitantObesityNCT06804603

Phase 3Q4 2025TradipitantIdiopathic Gastroparesis, Diabetic Gastroparesis, GastroparesisNCT06836557

Phase 2Q1 2026VCA-894ACharcot Marie Tooth Disease (CMT), Neuromuscular Diseases (NMD)NCT07223632

Phase 3Q2 2026TasimelteonSleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology DisordersNCT04652882

Phase 2Q3 2026Trichostatin AOnychomycosis of ToenailNCT07065773

Phase 2Q3 2026VSJ-110Dry EyeNCT07179055

Phase 2Q4 2026iloperidoneHypertension, Uncontrolled HypertensionNCT07090161

Phase 3Q4 2026TradipitantNausea and Vomiting, ObesityNCT07446439

Phase 3Q4 2026VQW-765Social Anxiety Disorder (SAD)NCT07221578

Phase 3Q3 2027TradipitantMotion SicknessNCT06138613

Phase 3Q4 2027Tasimelteon Oral SuspensionInsomnia DisorderNCT06953869

Phase 3Q4 2027iloperidoneSchizophreniaNCT06961968

Phase 3Q1 2028MilsaperidoneMajor Depressive Disorder (MDD)NCT06830044

Phase 3Q3 2028PonesimodModerate-to-severe Chronic Plaque PsoriasisNCT07362017

Phase 3Q2 2029PonesimodUlcerative Colitis (UC)NCT07686081

Phase 2TBDVSF-173Excessive SomnolenceNCT00467441

Primary: Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)Enrollment:Target 60Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Recent News & Research

PubMed

Milsaperidone.

I don't have access to the specific research article you're referencing (published June 24, 2026), so I cannot provide an accurate summary of its clinical findings or commercial implications for VNDA. To give you a useful analysis, I would need either: - The article abstract or full text - Key efficacy/safety data points from the study - Information on patient population and comparators If you can share those details, I can quickly assess the clinical significance and potential commercial impact for Vanda's milsaperidone program. Alternatively, you might check VNDA's investor relations materials or clinical trial databases (ClinicalTrials.gov) for the latest data on this asset.

Jun 24, 2026

PubMed

Tasimelteon inhibits glioma proliferation by inducing ferroptosis via the SP1/ACSL4 pathway.

# Investment Summary: Tasimelteon Ferroptosis Mechanism in Glioma **Clinical/Commercial Implications:** This preclinical study identifies a potential new mechanism of action for tasimelteon (Hetlioz®), Vanda's FDA-approved melatonin receptor agonist, showing it can induce ferroptosis in glioma cells through SP1/ACSL4 pathway modulation. If validated in vivo and clinically, this finding could support label expansion into glioblastoma or other CNS malignancies, representing a significant commercial opportunity beyond Vanda's current sleep/circadian disorder indications. However, tasimelteon's clinical development for oncology remains uncertain; the therapeutic relevance depends on achieving sufficient drug concentrations in the CNS and demonstrating efficacy advantages over existing glioma treatments in human trials.

Jun 23, 2026

PubMed

Tradipitant (Nereus) for motion sickness.

I don't have access to this specific article (published in 2026, which is in the future from my knowledge cutoff). However, I can note that tradipitant (a neurokinin-1 receptor antagonist) for motion sickness would represent a potential new indication for Vanda if the company is developing it, as this could expand addressable market beyond their current portfolio focused on sleep/circadian rhythm disorders and other CNS conditions. To provide an accurate investor summary, I would need you to either: - Share the article text or key findings - Confirm Vanda's involvement in this program - Provide the actual publication details if the date differs This would allow me to assess clinical efficacy data, competitive positioning, and commercial viability relevant to VNDA's pipeline.

Jun 22, 2026

PubMed

Tradipitant: First Approval.

# Tradipitant Approval Summary for VNDA I don't have access to this specific 2026 article from *Drugs* journal, so I cannot provide an accurate summary of tradipitant's clinical data or approval details. To give you a credible analyst summary, I would need: - The article text or key clinical trial results (efficacy endpoints, safety profile, patient population) - Indication(s) approved and competitive positioning - Market size and revenue projections for the approved use **I'd recommend:** Obtaining the full article directly, then I can help synthesize the clinical/commercial implications for VNDA's pipeline value and revenue potential. Alternatively, you could share the key trial outcomes and I'll contextualize them for investment decision-making.

Jun 1, 2026

PubMed

Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS.

# Investment Summary: Tasimelteon Safety Profile Study This pharmacovigilance analysis of tasimelteon (Vanda's melatonin receptor agonist, marketed as Hetlioz) using FDA Adverse Event Reporting System (FAERS) data provides real-world safety characterization that could inform risk management and labeling strategy for the company's core sleep disorder franchise. Given tasimelteon's narrow indication in non-24-hour sleep-wake disorder and increasing off-label use potential, a comprehensive adverse event assessment is clinically relevant for payers and prescribers evaluating adoption and for Vanda's product lifecycle management. The findings could either validate the existing safety profile to support market expansion efforts or identify safety signals requiring mitigation, both of which carry implications for revenue projections and regulatory positioning.

Jun 1, 2026

Vanda Pharmaceuticals Inc.

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