Top 5 Target	Count

CFTR(Cystic fibrosis transmembrane conductance regulator)	2
5-HT2A receptor x D2 receptor	1
Melatonin receptor	1
S1PR1(Sphingosine 1-phosphate receptor Edg-1)	1
HDACs(Histone deacetylase)	1

Drugs associated with Vanda Pharmaceuticals, Inc.

Ponesimod

Target

S1PR1

Mechanism

S1PR1 modulators

Active Org.

Actelion Pharmaceuticals US, Inc. [+7]

Originator Org.

Actelion Pharmaceuticals Ltd.

Active Indication

Multiple sclerosis relapse [+1]

Inactive Indication

Chronic graft-versus-host disease [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date18 Mar 2021

Tasimelteon

Target

Melatonin receptor

Mechanism

Melatonin receptor agonists

Active Org.

Vanda Pharmaceuticals Netherlands BV [+1]

Originator Org.

Vanda Pharmaceuticals, Inc.

Active Indication

Sleep Initiation and Maintenance Disorders [+5]

Inactive Indication

Depressive Disorder, Major [+6]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date31 Jan 2014

Iloperidone

Target

5-HT2A receptor x D2 receptor

Mechanism

5-HT2A receptor antagonists [+1]

Active Org.

Novartis AG [+2]

Originator Org.

Novartis Pharma AG

Active Indication

Bipolar I disorder [+2]

Inactive Indication

Acute schizophrenia [+7]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date06 May 2009

Clinical Trials associated with Vanda Pharmaceuticals, Inc.

NCT06494397 / Not yet recruitingPhase 1

Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions

Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.

Start Date01 Jul 2024

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT06296966 / RecruitingPhase 2

A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

Start Date29 Feb 2024

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT05922995 / Not yet recruitingEarly Phase 1IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

Start Date30 Sep 2023

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

100 Clinical Results associated with Vanda Pharmaceuticals, Inc.

0 Patents (Medical) associated with Vanda Pharmaceuticals, Inc.

Literatures (Medical) associated with Vanda Pharmaceuticals, Inc.

01 Oct 2024·Cornea

Pharmacogenomic Analysis of Response to Topical Tumor Necrosis Factor α Antagonist Licaminlimab (OCS-02) in Dry Eye Disease [RETRACTED]

Article

Author: Baudouin, Christophe ; Donnenfeld, Eric ; Weissgerber, Georges ; Perez, Victor L. ; He, Yunsheng ; Galor, Anat

Purpose:The purpose of this study was to evaluate the pharmacogenomics of response to topical ocular tumor necrosis factor α (TNFα) inhibitor licaminlimab in patients with DED.Methods:Three single-nucleotide polymorphisms (SNPs) associated with Sjögren syndrome, 3 in the TNFα gene and 1 in the TNF receptor 1 (TNFR1) gene, were assessed for association with response to licaminlimab in participants from a randomized, vehicle-controlled, Phase 2 study in which adults with DED and severe ocular discomfort persisting despite treatment with artificial tears received licaminlimab or vehicle for 6 weeks. Response was assessed for change from baseline in Global Ocular Discomfort score at Day 29 of treatment. The pharmacogenomic analysis was a prospectively specified exploratory objective of the study. mRNA expression for TNFα, interleukin (IL) 1β, and IL8 in conjunctival epithelium cells was determined. The relationship between SNPs and response to licaminlimab was assessed using a mixed model repeated measures analysis.Results:SNP rs1800693 in the TNFR1 gene showed a significant effect on response to licaminlimab (P < 0.0001, initial association test); no effect was seen for any of the other SNPs tested. The CC genotype of rs1800693 was associated with much greater response to licaminlimab than the CT or TT genotypes: LS mean changes from baseline to Day 29 in Global Ocular Discomfort score were −29.5, −0.09, and −3.90, in patients with the CC, CT, and TT genotypes, respectively (P < 0.0001). No significant effect was observed in vehicle-treated patients. Improvements from baseline were seen in 3/4 licaminlimab-treated participants with the CC genotype. Conjunctival epithelium cell levels of mRNA for TNFα, IL1β, and IL8 decreased from baseline in participants with the CC genotype, but not with the CT or TT genotypes. Between-genotype differences in mRNA levels were not observed in participants receiving vehicle.Conclusions:The CC genotype of rs1800693, relatively common in patients with DED, was strongly associated with response to licaminlimab and decreased inflammatory cytokine gene expression in ocular surface cells during treatment. This study is one of the first to our knowledge to investigate pharmacogenomics in the treatment of DED.

20 Apr 2024·SLEEP

0042 Melanopsin Crispants in Zebrafish Display Difference in Sleep Latency

Author: Polymeropoulos, Christos ; Keenan, Brendan ; Smieszek, Sandra ; Doldur-Balli, Fusun ; Veatch, Olivia ; Polymeropoulos, Mihael ; Birznieks, Gunther ; Zimmerman, Amber

AbstractIntroductionMelanopsin (OPN4) is a blue light sensitive opsin type G protein couple receptor. It is highly expressed in the photsenstive ganglion cells which mediate responses to light including regulation of sleep, circadian photoentrainment and pupillary light responses. Mutations in OPN4 were shown to affect responses to light ultimately affecting the regulation of circadian rhythms and sleep patterns. Sleep homeostasis was altered in homozygous knockout of Opn4, gene encoding for melanopsin, in mice. Human melanopsin variants which alter function significantly may contribute to sleep disturbance, circadian dysfunction and visual impairment. In order to further dissect the role of melanopsin in sleep in a diurnal vertebrate model, we created an F0 knockout model of opn4 gene in zebrafish and assessed sleep/wake phenotype.MethodsIn CRISPR/Cas9 screening, single cell-stage zebrafish embryos were injected with injection cocktail containing Cas9 protein and crRNAs targeting opn4a and opn4b, homologous genes of human OPN4. Control groups were negative control crRNA injected embryos. Zebrafish larvae were individually pipetted into each well of a 96 well plate. Larval zebrafish were raised on a 14 hour/10 hour light/dark cycle at 28.5◻C until sleep phenotyping starts. Sleep phenotyping was carried out between days 5-8 post injection.ResultsLonger sleep latency at night was observed in opn4 CRISPR knockout larvae. This is in line with prior literature. Additional tests by exposing opn4 crispants and control zebrafish larvae to white light and dark pulses at different times were performed however the activity and sleep latency did not change across groups.ConclusionSleep/wake phenotyping of opn4 (melanopsin) crispants in zebrafish displayed significant difference in sleep latency parameter compared to controls. Although additional tests carried out using pulses of white light need to be repeated, current results highlight the importance of OPN4 mediated pathways in affecting sleep latency.Support (if any)

20 Apr 2024·SLEEP

0041 Drug Screening and CRISPR/Cas9 Screening of HCN Channels

Author: Polymeropoulos, Christos ; Veatch, Olivia ; Polymeropoulos, Mihael ; Doldur-Balli, Fusun ; Zimmerman, Amber ; Smieszek, Sandra ; Keenan, Brendan ; Birznieks, Gunther

AbstractIntroductionA growing body of evidence suggests a role for HCN (hyperpolarization-activated cyclic nucleotide-gated) channels in regulation of sleep. We first tested effects of three HCN channel blockers (Corlanor, Zatebradine Hydrochloride and ZD7288) on sleep/wake behavior in wild type zebrafish compared to DMSO control. Then, to more definitively investigate roles of HCN channels, we knocked out genes encoding for HCN channel subunits in zebrafish by utilizing CRISPR/Cas9 technique and we assessed sleep/wake behavior in the HCN channel mutants.MethodsThe compounds were tested at six concentrations varying between 0.1-30 ◻M (.i.e., 0.1 μM, 0.3 μM, 1.0 μM, 4.5 μM, 10 μM and 30 μM) in zebrafish larvae in our drug screening study. Control groups were administered DMSO. In CRISPR screening, single cell-stage zebrafish embryos were injected with preformed ribonucleoprotein complexes containing Cas9 protein and two crRNAs targeting each homologous gene of human HCN1, HCN2, HCN3, and HCN4. Control groups were negative control crRNA injected embryos. Sleep phenotyping was performed by placing individual larva into the wells of 96 well plates and by recording their activity via commercially available video monitoring equipment.ResultsDrug screening study showed shorter latency to sleep at 0.1 μM dose of Ivabradine, moderate reductions in average activity at 30 μM dose of Zatebradine Hydrochloride, and increased sleep at 4.5 μM dose of ZD7288. Our CRISPR/Cas9 screening resulted in decreased activity in hcn1 crispants, fewer sleep bouts in daytime in hcn2 crispants, and no difference in sleep parameters in hcn3 crispants. hcn4 crispants had shorter sleep in both day and nighttime, hyperactivity and shorter sleep bouts at night and fewer sleep bouts in daytime.ConclusionBlocking HCN channels decreased wakefulness in our drug screening study. Genetically targeting hcn1 and hcn2 genes resulted in the same direction with the results of drug screening study and knocking out hcn3 didn’t change sleep parameters. Change in sleep parameters were in the opposite direction in hcn4 crispants. HCN channel blockers might be selecting HCN1 and HCN2 however further work is required to confirm this suggestion.Support (if any)

131

News (Medical) associated with Vanda Pharmaceuticals, Inc.

30 Oct 2024

·www.prnewswire.com

Vanda Pharmaceuticals to Announce Third Quarter 2024 Financial Results on November 6, 2024

Conference Call and Webcast to Follow WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, November 6, 2024, during which management will discuss the third quarter 2024 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 2555000. The conference call will be broadcast simultaneously and archived on Vanda's website, . Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 2024, at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2555000. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

15 Oct 2024

·endpts.com

Cycle makes another offer for Vanda; Ocean Biomedical, Molecure ink new deal

Plus, news about Gilead Sciences and Yuhan: Vanda gets second unsolicited offer: Cycle Group Holdings again submitted a proposal to buy Vanda for $8 per share in cash. Vanda, which is currently trading at about $4.87 $VNDA per share, rejected Cycle’s offer of the same size in May. It later received an FDA rejection for a gastrointestinal treatment in September. — Kyle LaHucik Ocean Biomedical, Molecure ink deal: The Rhode Island-based company will pay up to $32 million for access to Molecure’s preclinical YKL-40 inhibitor, called OAT-3912, and other inhibitors in that class. Molecure gets $600,000 in cash and stock to start. — Kyle LaHucik Gilead Sciences, Yuhan terminate deal : The companies “mutually agreed” to end an agreement first inked in 2019 to develop a pair of MASH therapies, according to a Gilead spokesperson. At the time, Gilead had paid $15 million upfront and promised up to $770 million in milestones. — Jaimy Lee

Acquisition

15 Oct 2024

·www.echemi.com

Vanda Pharmaceutical’s Stock Soars 11.37%! Rejects $800 Million Acquisition Offer from UK Company

In Monday's deal, Vanda Pharmaceutical Inc categorically rejected a second takeover proposal from Britain's Cycle Pharmaceuticals that valued the company at $8 per share. Vanda Pharmaceutical is sticking to its position despite a significant drop in its stock price following the US Food and Drug Administration's (FDA) refusal to approve its drug for a stomach ailment. In a formal statement, Vanda Pharmaceutical pointed out that Cycle Pharma's proposed acquisition terms are economically identical to the previous proposal that was evaluated and rejected by Vanda Pharmaceutical. This means that Cycle Pharma's latest offer did not convince Vanda Pharmaceutical's board. Cycle Pharma's $8 per share offer represents an 80% premium to Vanda Pharmaceutical's most recent closing price, valuing the company at $488 million. However, Vanda Pharmaceutical's Board of Directors believes that this valuation significantly undervalues the true value of the Company and is not in the best interests of the Company and its shareholders. Earlier, the FDA refused to approve Vanda Pharmaceutical's stomach disease drug, and the news sent shares of Vanda Pharmaceutical down 4.5%. In June, Vanda Pharmaceutical had already rejected Cycle Pharma's initial offer, as well as a revised offer from contract manufacturer Future Pak. To reduce the risk of a hostile takeover, Vanda Pharmaceutical adopted a shareholder rights plan, commonly known as a "poison pill," in April. Vanda Pharmaceutical has three approved products: Hetlioz for sleep disorders, Fanapt for bipolar I disorder and Ponvory for multiple sclerosis. After carefully reviewing Cycle Pharma's second proposal, Vanda Pharmaceutical's Board of Directors unanimously concluded that the proposal did not adequately reflect the value of Vanda Pharmaceutical and decided not to pursue the proposal. In a statement, Cycle Pharma said it remains willing to work with Vanda Pharmaceutical's board of directors and management team to reach an agreement that provides a compelling premium and some cash value to all of Vanda Pharmaceutical's shareholders. After Vanda Pharmaceutical rejected the takeover proposal, its shares rose 11.37 percent to $4.95 per share in trading on Monday. This increase in the share price reflects the market's positive reaction to Vanda Pharmaceutical's rejection of the acquisition proposal, as well as confidence in the company's future prospects.

Drug ApprovalAcquisition

100 Deals associated with Vanda Pharmaceuticals, Inc.

100 Translational Medicine associated with Vanda Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

IND Approval

Phase 2 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Tasimelteon ( Melatonin receptor )	Sleep Initiation and Maintenance Disorders More	Approved
Iloperidone ( 5-HT2A receptor x D2 receptor )	Schizophrenia More	Approved
Ponesimod ( S1PR1 )	Multiple sclerosis relapse More	Approved
Tradipitant ( NK1R )	Motion Sickness More	Phase 3
VHX-896	Bipolar I disorder More	Phase 3

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