Vanda Pharmaceuticals Inc.

VNDA

Held by 1 specialist biotech fund

1 fund opened new positions. Next phase3 readout (Tradipitant): Aug 2020. Short interest: 13.6% of float.

BiotechnologyCEO: Mihael H. PolymeropoulosIPO: 2006Website ↗

Vanda Pharmaceuticals Inc. is a biopharmaceutical company dedicated to developing and commercializing therapeutic solutions that address critical unmet medical needs. The company currently offers two approved treatments: HETLIOZ, prescribed for non-24-hour sleep-wake disorders, and Fanapt oral tablets, used in the management of schizophrenia. Vanda maintains an active and diverse development pipeline, exploring new applications for its existing therapies and advancing a range of novel compounds. This includes expanding HETLIOZ (tasimelteon) to potentially treat conditions such as jet lag disorder, Smith-Magenis Syndrome, pediatric Non-24, autism spectrum disorder, and delayed sleep phase disorder. Fanapt (iloperidone) is being investigated for bipolar disorder, alongside the creation of a long-acting injectable formulation for schizophrenia. Other promising candidates in development include: Tradipitant (VLY-686): A small molecule neurokinin-1 receptor (NK-1R) antagonist for atopic dermatitis, gastroparesis, and motion sickness. VTR-297: A small molecule histone deacetylase inhibitor, primarily for hematologic malignancies but with broader oncology potential. VQW-765: A small molecule nicotinic acetylcholine receptor partial agonist targeting psychiatric disorders. A portfolio of cystic fibrosis transmembrane conductance regulator (CFTR) activators and inhibitors aimed at dry eye and ocular inflammation. BPO-27: For secretory diarrhea disorders, including cholera. VHX-896: The active metabolite of iloperidone. Vanda Pharmaceuticals Inc. markets its products in the United States, Europe, and Israel. The company was established in 2002 and is headquartered in Washington, D.C.

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

Primary: Latency to Persistent Sleep, as measured by polysomnography. (Two Nights)Enrollment:Target 60Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2025TradipitantObesityNCT06804603

Phase 3Q4 2025TradipitantIdiopathic Gastroparesis, Diabetic Gastroparesis, GastroparesisNCT06836557

Primary: Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS (12 weeks)Enrollment:Target 100Sites: 3NA, TREATMENT

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

Primary: Assessment of safety of therapy with VCA-894A when administered via intrathecal injection, as measured by the incidence of adverse events. (631 days)Enrollment:1/1Sites: 1NA, TREATMENT

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

Primary: Change in Sleep Onset over the treatment period, as measured by sleep diary. (28 days)Enrollment:Target 70Sites: 17RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2026VSJ-110Dry EyeNCT07179055

Primary: Corneal Staining (Measured over an 8-week treatment period)Enrollment:Target 160Sites: 5RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2026Trichostatin AOnychomycosis of ToenailNCT07065773

Primary: Safety and Tolerability (24 weeks)Enrollment:Target 50Sites: 5NA, TREATMENT

Phase 2Q4 2026iloperidoneHypertension, Uncontrolled HypertensionNCT07090161

Primary: Change from baseline to treatment week 4 in SiSBP (screening to treatment week 4)Enrollment:Target 240Sites: 28RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2026TradipitantNausea and Vomiting, ObesityNCT07446439

Primary: Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary. (1 week)Enrollment:Target 280Sites: 10RANDOMIZED, QUADRUPLE, TREATMENT

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

Primary: Subjective Units of Distress Scale (SUDS) (1 day)Enrollment:Target 500Sites: 30RANDOMIZED, QUADRUPLE, TREATMENT

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

Long-term safety and efficacy of ponesimod, an oral S1P1 receptor modulator, in relapsing-remitting multiple sclerosis (RRMS): Results from randomized phase 2b core and extension studies spanning up to 13 years.

# Investment Summary: Ponesimod Long-Term Data for VNDA Vanda's ponesimod demonstrates sustained safety and efficacy over 13 years in RRMS patients, supporting the durability profile needed for competitive positioning in the crowded MS market dominated by established therapies and newer competitors. The extended follow-up data strengthens clinical credibility for long-term patient compliance and reduces safety concerns that could otherwise limit adoption or trigger regulatory restrictions. This evidence is commercially relevant as it may support label expansion, address physician hesitancy regarding safety monitoring requirements, and potentially improve market share against alternative S1P1 modulators (fingolimod, siponimod, ozanimod), though competitive differentiation and pricing power remain dependent on comparative efficacy/safety profiles not specified here.

Oct 1, 2026

PubMed

Efficacy and safety of tradipitant in motion sickness: a systematic review and meta-analysis.

# Investment Summary: Tradipitant Motion Sickness Meta-Analysis **Clinical Finding:** This systematic review and meta-analysis demonstrates tradipitant's efficacy and safety profile in treating motion sickness, supporting its clinical utility as a potential therapeutic option in Vanda's pipeline. **Commercial Implication:** Motion sickness represents a viable but niche commercial opportunity; the meta-analysis validates the drug candidate's evidence base, though market size and competitive positioning (versus established antihistamines and scopolamine) will determine whether this indication materially contributes to VNDA's revenue growth or serves primarily as a supporting indication for a multi-indication asset. **Investor Consideration:** Investors should monitor whether Vanda advances tradipitant in motion sickness toward regulatory filing and assess the indication's commercial prioritization relative to the company's existing approved products (Hetlioz, Fanapt) and other pipeline assets with larger

Aug 12, 2026

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

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