VNDA Vanda Pharmaceuticals Inc.

9.66
+0.15  (+2%)
Previous Close 9.51
Open 9.55
52 Week Low 7.12
52 Week High 17.85
Market Cap $527,932,514
Shares 54,651,399
Float 43,953,164
Enterprise Value $183,949,552
Volume 549,330
Av. Daily Volume 619,849
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HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
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Drug Pipeline

Drug Stage Notes
Tradipitant - EPIONE 2
Atopic dermatitis
Phase 3
Phase 3
Phase 3 enrolment commenced October 2019. On hold due to COVID-19.
Tradipitant
Gastroparesis
Phase 3
Phase 3
Phase 3 enrollment to be completed 1H 2021.
Tradipitant - ODYSSEY VLY-686-3501
Pneumonia associated with COVID-19
Phase 3
Phase 3
Phase 3 data August 18, 2020 noted statistically significant improvement by Day 7. However, improvement was not statistically significant at Day 28.
Tradipitant
Motion sickness
Phase 3
Phase 3
Phase 3 new enrolment on hold due to COVID-19.
Fanapt
Bipolar Disorder
Phase 2
Phase 2
Phase 3 trial on hold due to COVID-19.
HETLIOZ (tasimelteon)
Delayed sleep phase disorder (DSPD)
Phase 2
Phase 2
Phase 3 trial on hold due to COVID-19.
Tradipitant - EPIONE 1
Atopic dermatitis
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 25, 2020.
HETLIOZ (tasimelteon)
Jet Lag Disorder
CRL
CRL
CRL issued August 19, 2019.
Fanapt
Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.
Approved
Approved
Approved May 26, 2016.
HETLIOZ (tasimelteon)
Insomnia
Approved
Approved
Approved January 31, 2014.

Latest News

  1. Vanda Pharmaceuticals Provides Update on Tradipitant Development Program

    WASHINGTON, Aug. 31, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today provided an update on its development program for tradipitant.

    • Enrollment in Vanda's Phase III clinical study (VP-VLY-686-3303) in gastroparesis is expected to be completed in the first half of 2021
    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology1
    • A new gastroparesis therapy could present a significant commercial opportunity, with an estimated 6 million people in the U.S. suffering from gastroparesis
    • Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with…

    WASHINGTON, Aug. 31, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today provided an update on its development program for tradipitant.

    • Enrollment in Vanda's Phase III clinical study (VP-VLY-686-3303) in gastroparesis is expected to be completed in the first half of 2021
    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology1
    • A new gastroparesis therapy could present a significant commercial opportunity, with an estimated 6 million people in the U.S. suffering from gastroparesis
    • Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia2
    • Vanda is pursuing multiple short-term and long-term indications for tradipitant, including treatment of gastroparesis, COVID-19 pneumonia, motion sickness, and atopic dermatitis

    Clinical progress of tradipitant in gastroparesis

    Tradipitant is advancing in a Phase III study for the treatment of both diabetic and idiopathic gastroparesis.  This study is 30% enrolled at a target of 200 randomized patients, and is expected to complete enrollment in the first half of 2021.  The previous Phase II study showed significant improvement in nausea, the key symptom of gastroparesis, as well as significant improvement in the number of nausea-free days, in patients treated with 85 mg of tradipitant twice a day for 4 weeks.  The Phase III study is a 12-week study of similar design to the Phase II study in both target population and endpoints. 

    The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology.  A preprint is available online here.  The article describes the results of Vanda's Phase II double-blind trial of 152 adults with gastroparesis at 47 sites in the U.S. from November 2016 through December 2018.  Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (p=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; p=.0160). Patients with nausea and vomiting at baseline (n=101) had an even greater decrease in nausea when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (p<.0001), as well as an increase in nausea-free days at week 4 (32.3% improvement on tradipitant vs 7.6% on placebo; p=.0003). The average nausea score was 1 or less at week 4 in 32.9% of patients given tradipitant compared with 11.8% of patients given placebo (p=.0013). A greater than 1-point improvement in the gastroparesis cardinal symptom index score was observed in 46.6% of patients given tradipitant compared with 23.5% of patients given placebo (p=.0053). 

    In July 2020, the U.S. Food and Drug Administration (FDA) approved the use of tradipitant for up to 6 months with an option of renewal for an individual patient who requested expanded access.  Since then, other patients who experienced a unique benefit in tradipitant studies have requested expanded access and their applications are currently under review by the FDA. Although this expanded access program is not intended primarily for data collection, Vanda will collect safety data from this cohort of expanded access patients and include this data in its New Drug Application (NDA) for gastroparesis.

    Preclinical and safety data for tradipitant

    A robust package of preclinical work for tradipitant has been completed, including a 2-year carcinogenicity study, depicted in Figure 1.  Figure 1 also includes a summary of the human studies through Phase II. 

    The results from these animal and human studies demonstrate tradipitant's extensive animal and human testing, and well-established safety profile. No significant safety signals were observed in these studies that would be both predictive of clinical safety and would preclude all further clinical development.  In the human studies, tradipitant was well tolerated in individuals who received daily doses of tradipitant ranging from less than 50 mg/day to over 170 mg/day. 

    Vanda believes this entire preclinical package is adequate to support NDA filings for the short-term indications being pursued.  The FDA has communicated, however, that for treating patients beyond 12 weeks, it is requiring Vanda to conduct what it considers to be a standard 9-month non-rodent chronic toxicity study, which currently limits Vanda's ability to collect safety data in humans for more than 12 weeks.

    The FDA-required study design necessitates the sacrifice of dozens of animals and Vanda has disputed the necessity of a 9-month non-rodent chronic toxicity study.  Vanda has taken a public position that unnecessary lethal animal studies should not be conducted, especially in dogs, as such studies are not scientifically justified and would not be consistent with Vanda's scientific and ethical principles, which are shared by many Americans.  Vanda is working with the FDA to resolve this disagreement.

    Despite the disagreement with the FDA, the preclinical package has allowed Vanda to continue to conduct all the efficacy studies necessary for NDA filing.  The lack of long-term (>12 weeks in humans) safety data would likely impact the FDA's willingness to approve tradipitant for a chronic indication.  However, because long-term safety data is not normally a requirement for short-term indications, and with a preclinical profile that has not precluded clinical development, Vanda believes the package is complete for any NDA filing to treat patients for 12 weeks or less.  In gastroparesis, for example, the FDA has communicated to Vanda that it is considering an indication for the short-term relief of nausea in gastroparesis.  While this short-term indication is not preferred, Vanda would consider accepting this limited indication while continuing to pursue a chronic indication.  The chronic treatment of itch in atopic dermatitis would be expected to have a similar issue in review as gastroparesis.

    The indications of motion sickness and the acute respiratory distress (pneumonia) associated with COVID-19 are both short-term indications covering either short-term travel, in the case of motion sickness, or a week to several weeks course of treatment in the case of COVID-19 pneumonia.  At this time, the COVID-19 pneumonia program is recruiting patients in the Phase III ODYSSEY study.  Preparations for the motion sickness study have resumed and the study will commence when local restrictions related to the global COVID-19 pandemic are lifted.  Recruiting in the atopic dermatitis study remains on hold.

    Potential market opportunity for gastroparesis

    Gastroparesis is a severe, significantly underdiagnosed disease with increased morbidity and mortality, representing a significant unmet medical need.  The only FDA approved treatment currently available is metoclopramide, which carries a label restriction of up to 3 months treatment because of increased risk of Parkinson's-like symptoms that can be permanent.  Off label treatments include erythromycin, botulinum toxin injections and gastric stimulators, none of which provide a significant benefit.  Anti-nausea agents, including ondansetron, are also used as needed, although with incomplete relief. 

    As a result of this lack of effective therapeutic options, patients with gastroparesis experience a significant adverse impact on their social and occupational functioning in addition to physical symptoms.  Given the magnitude of improvements seen in the Phase II study, tradipitant has the potential to become the first line option for the treatment of gastroparesis.  As a result of underdiagnosis, it is difficult to estimate with any precision the number of patients that could be treated with tradipitant.  IQVIA reports more than 300,000 monthly metoclopramide prescriptions, the equivalent of 300,000 patients treated with this drug, which is primarily used in the treatment of gastroparesis.  However, the concentrated base of gastroenterology specialists and the development of new and easy to use diagnostics, such as a recently approved breath test that can be performed at home, along with Vanda's significant experience with patient-based marketing and direct-to-consumer awareness campaigns, could represent a large commercial opportunity for Vanda. 

    Potential timeline and estimated milestones for tradipitant in gastroparesis

    • Q3 2020, Expanded Access individual patient program
    • First Half 2021, Enrollment completion of the Phase III study
    • Second Half 2021, NDA submission for tradipitant in gastroparesis
    • Second Half 2022, Commercial launch of tradipitant for the treatment of gastroparesis, if approved

    About Tradipitant

    Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company.  Tradipitant is currently in clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis.  The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

    References

    1 Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Gastroenterology. Advance online publication. https://doi.org/10.1053/j.gastro.2020.07.029

    2 Refer to Company press release titled "Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia" issued on August 18, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14256/pdf

    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 www.vandapharma.com and follow us on Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding the completion of Vanda's Phase III study of tradipitant for the treatment of gastroparesis, the potential commercial opportunity for tradipitant, the ability of tradipitant to be a first line treatment option for patients with gastroparesis, the adequacy of Vanda's safety data and Vanda's pursuit of both long-term and short-term indications for gastroparesis, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete enrollment for its Phase III study of tradipitant for the treatment of gastroparesis, Vanda's ability to complete the clinical development of, submit NDAs for and obtain regulatory approval of tradipitant in the treatment of gastroparesis, motion sickness and atopic dermatitis, Vanda's ability to resolve its disagreement with the FDA regarding the conduct of a 9-month non-rodent chronic toxicity study, and the FDA's assessment of the adequacy of Vanda's safety and efficacy data. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-provides-update-on-tradipitant-development-program-301121338.html

    SOURCE Vanda Pharmaceuticals Inc.

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  2. Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia

    WASHINGTON, Aug. 18, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study.

    • Interim analysis of the ODYSSEY study showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375)
    • Tradipitant numerically improved median time to clinical improvement by day 28 (HR=1.55, p=0.2254)
    • Similar overall rates of improvement and mortality were observed for the two treatment arms at day 28

    The interim analysis of the ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia improved sooner when treated with tradipitant as compared to…

    WASHINGTON, Aug. 18, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study.

    • Interim analysis of the ODYSSEY study showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375)
    • Tradipitant numerically improved median time to clinical improvement by day 28 (HR=1.55, p=0.2254)
    • Similar overall rates of improvement and mortality were observed for the two treatment arms at day 28

    The interim analysis of the ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia improved sooner when treated with tradipitant as compared to placebo. This finding was based on a preliminary analysis of the first 60 patients enrolled in the ODYSSEY study of tradipitant in COVID-19 pneumonia. ODYSSEY is an ongoing Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor (NK-1R) antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection, which was initiated in April 2020. The study is expected to enroll 300 patients, and as of July 15, 2020, 60 patients had enrolled and completed the study. Because this is the first study of tradipitant for this indication and given the increased rate of mortality seen with COVID-19 pneumonia, an interim analysis was planned to better assess the efficacy and safety of tradipitant in this population of COVID-19 patients.

    In the ODYSSEY study, clinical status was assessed on a 7 point scale ranging from death, to mechanical ventilation, various levels of oxygen requirements, to hospital discharge. Clinical improvement was defined as at least a 2 point improvement in the 7 point ordinal scale.

    • Interim analysis in the first 60 enrolled patients showed that similar percentages of patients improved between the two treatment arms, 57% for tradipitant and 50% for placebo. The mortality rate was also similar between the treatment groups with 14.2% for tradipitant and 16.6% for placebo.
    • In the time to improvement analysis, after 7 days of treatment, patients treated with tradipitant recovered earlier than those receiving placebo, which was statistically significant (HR=2.55, p=0.0375). This benefit was generally consistent among patients of varying degree of severity at baseline. At day 28 of the study, tradipitant showed a numerical benefit over placebo with an earlier median time to recovery (HR=1.55, p=0.2254, median time to improvement 10 days for tradipitant and 28 days for placebo).

    This early analysis suggests that tradipitant may act by accelerating the time to clinical improvement for patients with severe COVID-19 pneumonia. If confirmed, this effect may be of significant clinical benefit for patients as well as for public health by decreasing the amount of resources employed in the treatment of patients with COVID-19 pneumonia. Although preliminary, the interim results from this randomized controlled study of tradipitant in COVID-19 pneumonia are encouraging. A larger sample size would be required to definitively determine whether tradipitant offers a therapeutic benefit in hospitalized patients with COVID-19 pneumonia by accelerating time to clinical improvement. The results from this interim analysis will be submitted for publication in a peer reviewed journal.

    The hypothesized mechanism of action of tradipitant as an anti-inflammatory agent in COVID-19 pneumonia potentially would be complementary to antiviral treatments. Ongoing efforts in the development of COVID-19 therapeutics require coordination and cooperation between parties if they are to result in the discovery of useful therapeutics. Vanda looks forward to collaborating with U.S. government agencies and hospitals across the country to confirm these findings expediently. If these results are confirmed, tradipitant could become part of the standard of care, either alone or in combination with antivirals, for patients with COVID-19 pneumonia. 

    "These results, albeit preliminary, are exciting, offering the promise of a significant contribution in the treatment of COVID-19 and the prospect of making tradipitant part of the standard of care in accelerating recovery for patients with COVID-19 pneumonia," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda.

    Vanda has scaled up the commercial manufacturing of tradipitant and significant supplies are expected to be available in the coming months. As the results today may suggest that tradipitant's effects in accelerating recovery may not be restricted to just COVID-19 pneumonia, Vanda also plans to evaluate a clinical program to assess the efficacy of tradipitant in the treatment of seasonal influenza pneumonia.

    Table 1.  Baseline Demographic Summary. Intention-to-Treat Population

























    Characteristic

    Tradipitant 



    Placebo



    Total

     Statistic

    (N= 28)



    (N= 30) 



    (N= 58)

























    Age (years)

    71.0 (62.5 - 77.5)



    66.5 (58.0 - 72.0)



    68.5 (61.0 - 77.0)













    Sex, n (%)











     Male

    20 ( 71.4)



    20 ( 66.7)



    40 ( 69.0)

     Female

    8 ( 28.6)



    10 ( 33.3)



    18 ( 31.0)













    Any Comorbidities, n (%)

    27 ( 96.4)



    28 ( 93.3)



    55 ( 94.8)

     Hypertension

    11 ( 39.3)



    15 ( 50.0)



    26 ( 44.8)

     Diabetes

    8 ( 28.6)



    7 ( 23.3)



    15 ( 25.9)

     Coronary Heart Disease

    1 (  3.6)



    4 ( 13.3)



    5 (  8.6)

     Asthma

    1 (  3.6)



    4 ( 13.3)



    5 (  8.6)













    7 Point Ordinal Scale at Baseline, n (%)











     2 - Hospitalized on mechanical ventilation or ECMO

    4 ( 14.3)



    2 (  6.7)



    6 ( 10.3)

     3 - Hospitalized on non-invasive ventilation or high-flow oxygen supplement

    13 ( 46.4)



    12 ( 40.0)



    25 ( 43.1)

     4 - Hospitalized requiring supplemental oxygen

    9 ( 32.1)



    16 ( 53.3)



    25 ( 43.1)

     5 - Hospitalized not requiring supplemental oxygen, requiring continued medical care

    2 (  7.1)



    0 (  0.0)



    2 (  3.4)













    Time from Hospitalization to Starting Study Treatment, Days 

    4.0 (2.0 - 6.5)



    6.0 (2.0 - 12.0)



    4.0 (2.0 - 9.0)

     Early (<=10 Days from Hospitalization)

    23 ( 82.1)



    22 ( 73.3)



    45 ( 77.6)

     Late (>10 Days from Hospitalization)

    5 ( 17.9)



    8 ( 26.7)



    13 ( 22.4)













    Highest Oxygen Therapy Support , n (%)











     Room Air

    1 (  3.6)



    0 (  0.0)



    1 (  1.7)

     Nasal Cannula (NC)

    5 ( 17.9)



    6 ( 20.0)



    11 ( 19.0)

     Non Rebreather (NRB)

    1 (  3.6)



    2 (  6.7)



    3 (  5.2)

     High Flow Nasal Cannula (HFNC)

    6 ( 21.4)



    9 ( 30.0)



    15 ( 25.9)

     CPAP Mask

    0 (  0.0)



    2 (  6.7)



    2 (  3.4)

     BiPAP Mask

    1 (  3.6)



    1 (  3.3)



    2 (  3.4)

     Mechanical Ventilation

    14 ( 50.0)



    10 ( 33.3)



    24 ( 41.4)





    % = 100 x n/N. Data are median (IQR).



     

    Table 2.  Outcomes Overall and According to Score on the Ordinal Scale at Day 7. Intention-to-Treat Population







     Overall*









    Ordinal Score at Baseline*























    4







    3







    2



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    (N= 28)



    (N= 30)



    (N=  9)



    (N= 16)



    (N= 13)



    (N= 12)



    (N=  4)



    (N=  2)





    Responder as Improvement of 2 or More Points





















       No. of responders

    13



    7



    6



    6



    2



    1



    3



    0

       Median time to responder

    . (4-NE)



    . (NE-NE)



    4 (3-NE)



    . (4-NE)



    . (5-NE)



    . (NE-NE)



    4 (2-NE)



    . (NE-NE)

         (95% CI) — days































       Hazard ratio (95% CI)**

    2.55 (1.02-6.42 [0.0461])



     2.23 (0.71-6.98 [0.1673])



    2.19 (0.20-24.18 [0.5225])



    NE (0.00-NE [0.9983])

































    Mortality































       Hazard ratio (95% CI)†

    2.65 (0.24-29.29 [0.4255])



     3.14 (0.20-50.23 [0.4186])



    . (NE - NE [NE])



    NE (0.00-NE [0.9985])

       No. of deaths by day 7

    2



    1



    1



    1



    0



    0



    1



    0

       KM estimate — %

    9.8



    3.8



    25.0



    8.3



    0.0



    0.0



    25.0



    0.0

         (95% CI)

    (2.5-33.8)



    (0.6-24.3)



    (3.9-87.2)



    (1.2-46.1)



    (0.0-0.0)



    (0.0-0.0)



    (3.9-87.2)



    (0.0-0.0)

































    Ordinal Score at Day 7 Days — no. (%)‡





















      Patients with baseline

    28



    30



    9



    16



    13



    12



    4



    2

      and day 7 score data































    1

    2 (7.1)



    1 (3.3)



    1 (11.1)



    1 (6.3)



    0 (0.0)



    0 (0.0)



    1 (25.0)



    0 (0.0)

    2

    9 (32.1)



    8 (26.7)



    0 (0.0)



    2 (12.5)



    8 (61.5)



    4 (33.3)



    1 (25.0)



    2 (100.0)

    3

    4 (14.3)



    5 (16.7)



    1 (11.1)



    1 (6.3)



    3 (23.1)



    4 (33.3)



    0 (0.0)



    0 (0.0)

    4

    2 (7.1)



    9 (30.0)



    1 (11.1)



    6 (37.5)



    0 (0.0)



    3 (25.0)



    1 (25.0)



    0 (0.0)

    5

    2 (7.1)



    0 (0.0)



    0 (0.0)



    0 (0.0)



    1 (7.7)



    0 (0.0)



    1 (25.0)



    0 (0.0)

    7

    9 (32.1)



    7 (23.3)



    6 (66.7)



    6 (37.5)



    1 (7.7)



    1 (8.3)



    0 (0.0)



    0 (0.0)

      Odds ratio (95% CI)

    1.05 (0.42-2.63 [0.9149])



    0.40 (0.08-2.02 [0.2692])



    2.69 (0.60-12.18 [0.1980])



    0.43 (0.02-11.53 [0.6180])







    *

    P values and confidence intervals have not been adjusted for multiple comparisons. NE denotes not possible to estimate.

    **

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios bigger than 1 indicate a benefit for tradipitant.

    †

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios less than 1 indicate a benefit for tradipitant.

    ‡

    Odds ratios and P values were calculated with the use of a proportional odds model. Odds ratio values greater than 1 indicate a benefit for tradipitant.

     

    Table 3.  Outcomes Overall and According to Score on the Ordinal Scale at Day 28. Intention-to-Treat Population







    Overall*                                     



    Ordinal Score at Baseline*























    4







    3







    2



    Tradipitant  



    Placebo   



    Tradipitant 



    Placebo   



    Tradipitant 



    Placebo   



    Tradipitant 



    Placebo



    (N= 28)    



    (N= 30)  



    (N=  9) 



    (N= 16)   



    (N= 13)   



    (N= 12)  



    (N=  4)   



    (N=  2)





    Responder as Improvement of 2 or More Points



















       No. of responders       

    16



    15



    7



    11



    4



    4



    3



    0

       Median time to responder

    10 (4-NE)  



    27 (8-NE) 



    4 (3-NE)   



    9 (4-NE)   



    27 (5-NE) 



    . (7-NE)   



    4 (2-NE)   



    . (NE-NE)

           (95% CI) — days































       Hazard ratio (95% CI)** 

    1.55 (0.76-3.14 [0.2267]) 



    1.59 (0.61-4.15 [0.3396]) 



    1.08 (0.27-4.35 [0.9086]) 



    NE (0.00-  [0.9983])

































    Mortality































       Hazard ratio (95% CI)†  

    1.03 (0.28-3.85 [0.9610]) 



    1.24 (0.13-11.99 [0.8543]) 



    0.95 (0.06-15.26 [0.9731])



    1.84 (0.15-22.52 [0.6328])

       No. of deaths by day 28 

    4



    5



    1



    3



    1



    1



    2



    1

       KM estimate — %         

    20.4



    25.9



    25.0



    35.8



    9.1



    11.1



    50.0



    50.0

           (95% CI)              

    (8.2-45.7)  



    (11.5-52.2)



    (3.9-87.2) 



    (12.4-77.5) 



    (1.3-49.2)  



    (1.6-56.7) 



    (15.5-94.2) 



    (9.0-99.4)

































    Ordinal Score at Day 28 Days — no. (%)‡



















      Patients with baseline  

    28



    30



    9



    16



    13



    12



    4



    2

      and day 28 score data































    1

    4 (14.3)



    5 (16.7)



    1 (11.1)



    3 (18.8)



    1 (7.7)



    1 (8.3)



    2 (50.0)



    1 (50.0)

    2

    8 (28.6)



    5 (16.7)



    0 (0.0)



    1 (6.3)



    8 (61.5)



    3 (25.0)



    0 (0.0)



    1 (50.0)

    3

    1 (3.6)



    2 (6.7)



    1 (11.1)



    0 (0.0)



    0 (0.0)



    2 (16.7)



    0 (0.0)



    0 (0.0)

    4

    0 (0.0)



    3 (10.0)



    0 (0.0)



    1 (6.3)



    0 (0.0)



    2 (16.7)



    0 (0.0)



    0 (0.0)

    7

    15 (53.6)



    15 (50.0)



    7 (77.8)



    11 (68.8)



    4 (30.8)



    4 (33.3)



    2 (50.0)



    0 (0.0)

      Odds ratio (95% CI)     

    1.01 (0.38-2.67 [0.9795]) 



    0.62 (0.09-4.02 [0.6119])



    2.21 (0.50-9.71 [0.2941])



    0.43 (0.02-12.22 [0.6242])







    *

    P values and confidence intervals have not been adjusted for multiple comparisons. NE denotes not possible to estimate.

    **

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios bigger than 1 indicate a benefit for tradipitant.

    †

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios less than 1 indicate a benefit for tradipitant.

    ‡

    Odds ratios and P values were calculated with the use of a proportional odds model. Odds ratio values greater than 1 indicate a benefit for tradipitant.

     

     

    About Tradipitant

    Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

    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 www.vandapharma.com and follow us on Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding the potential for tradipitant to be a safe and effective treatment for COVID-19 pneumonia and seasonal influenza pneumonia and Vanda's ability to make tradipitant available to patients for the treatment of COVID-19 pneumonia and seasonal influenza pneumonia are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to fully enroll and complete the ODYSSEY study and Vanda's ability to complete the development of, and obtain regulatory approval for, tradipitant for the treatment of COVID-19 pneumonia and seasonal influenza pneumonia. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-interim-analysis-from-odyssey-study-shows-tradipitant-may-accelerate-clinical-improvement-in-patients-with-covid-19-pneumonia-301113676.html

    SOURCE Vanda Pharmaceuticals Inc.

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  3. Vanda Pharmaceuticals Reports Second Quarter 2020 Financial Results

    WASHINGTON, Aug. 5, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2020.

    "We are very proud of the achievements of our team, especially the record commercial performance, even in the face of the challenges presented by the pandemic. We are also very excited with the progress of the HETLIOZ® SMS applications as we get closer to providing a therapeutic solution to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights  

    • Total revenues from HETLIOZ® and Fanapt® were $62.2 million in the second quarter of 2020, a 5% increase compared to $59.1 million in the second quarter…

    WASHINGTON, Aug. 5, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2020.

    "We are very proud of the achievements of our team, especially the record commercial performance, even in the face of the challenges presented by the pandemic. We are also very excited with the progress of the HETLIOZ® SMS applications as we get closer to providing a therapeutic solution to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights  

    • Total revenues from HETLIOZ® and Fanapt® were $62.2 million in the second quarter of 2020, a 5% increase compared to $59.1 million in the second quarter of 2019.
    • HETLIOZ® net product sales were $41.6 million in the second quarter of 2020, a 10% increase compared to $37.8 million in the second quarter of 2019.
    • Fanapt® net product sales were $20.6 million in the second quarter of 2020, a 3% decrease compared to $21.2 million in the second quarter of 2019.
    • Cash, cash equivalents and marketable securities (Cash) were $339.8 million as of June 30, 2020, representing an increase to Cash of $47.2 million compared to June 30, 2019.
    • Net income was $8.7 million in the second quarter of 2020 compared to net income of $11.5 million in the second quarter of 2019.

    Key Product and Pipeline Highlights

    Products

    Vanda is encouraged by its record commercial performance during the second quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the launch of a Fanapt® for schizophrenia direct-to-consumer campaign at the end of the second quarter of 2020.

    Pipeline

    The COVID-19 pandemic has impacted clinical research globally, including Vanda's previously reported clinical trials. The tradipitant gastroparesis and motion sickness programs have resumed, while recruitment for the tradipitant atopic dermatitis program, as well as the HETLIOZ® delayed sleep phase disorder study and Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.

    Tradipitant

    • An Individual Patient Expanded Access protocol (VP-VLY-686-3303) for tradipitant in gastroparesis was approved by the U.S. Food and Drug Administration (FDA) and the patient was enrolled in July 2020. Under this protocol, this patient will receive tradipitant treatment for a period of up to six months, which may be extended upon review by the FDA.
    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) resumed recruitment. Enrollment in this 200-person study is expected to be completed in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
    • The protocol for the pivotal Phase III motion sickness study was discussed with the FDA at the end of Phase II meeting, and the FDA agrees with the adequacy of the program design to support an application. Preparations for this study have begun with the boat trip portion of the study expected to commence as soon as local restrictions are lifted.
    • Patient enrollment in the Phase III clinical study (ODYSSEY VLY-686-3501) of tradipitant in COVID-19 Acute Respiratory Distress Syndrome (ARDS) is ongoing and an interim analysis will be conducted to determine next steps.

    HETLIOZ® (tasimelteon)

    • The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the FDA for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of December 1, 2020.1
    • The FDA appeals process related to the sNDA for HETLIOZ® for the treatment of jet lag disorder is ongoing.

    Key Publications

    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in the July 2020 issue of Gastroenterology.2
    • The article "Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial" was published in the July 2020 issue of Frontiers in Neurology.3

    GAAP Financial Results

    Net income was $8.7 million in the second quarter of 2020, compared to net income of $11.5 million in the second quarter of 2019. Diluted net income per share was $0.16 in the second quarter of 2020, compared to diluted net income per share of $0.21 in the second quarter of 2019.

    2020 Financial Guidance

    Vanda will continue to assess the impact of the evolving pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance previously communicated by Vanda is shown below. In addition, Vanda provides an update to Year-end 2020 Cash.

    Full Year 2020

    Financial Objectives

     

    Full Year 2020

    Guidance

                           

     

    Total revenues

     

    $240 to $260 million

     

    HETLIOZ® net product sales

     

    $155 to $165 million

     

    Fanapt® net product sales

     

    $85 to $95 million

    Year-end 2020 Cash

     

    Greater than $340 million as compared to prior

    guidance of greater than $320 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, August 5, 2020, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2020 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days.

    References:

    1 Refer to Company press release titled "FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome" issued on August 3, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14226/pdf

    2 Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Gastroenterology. Advance online publication. https://doi.org/10.1053/j.gastro.2020.07.029

    3 Polymeropoulos, C. M., Mohrman, M. A., Keefe, M. S., Brzezynski, J. L., Wang, J., Prokosch, L. S., Polymeropoulos, V. M., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2020). Efficacy of tasimelteon (Hetlioz®) in the treatment of jet lag disorder evaluated in an 8-h phase advance model; a multicenter, randomized, double-blind, placebo-controlled trial. Frontiers in Neurology, 11, 611. https://doi.org/10.3389/fneur.2020.00611

    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 www.vandapharma.com and follow us on Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above and statements regarding Vanda's ability to make HETLIOZ® available to patients with SMS, Vanda's marketing and sales strategies, the Individual Patient Expanded Access protocol for tradipitant, recruitment for the gastroparesis, motion sickness and ODYSSEY studies and clinical development and regulatory timelines for tradipitant and HETLIOZ® are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's assumptions regarding its ability to continue to grow its business in the U.S.; Vanda's ability to minimize the disruption caused by, and maintain business continuity during, the global COVID-19 pandemic and related market volatility; the duration and severity of the global COVID-19 pandemic, including prevailing economic conditions and general uncertainties relating thereto that may be unknown and unforeseeable; Vanda's ability to enroll patients in and complete its gastroparesis, motion sickness and ODYSSEY studies; Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis, motion sickness, atopic dermatitis and COVID-19 ARDS; Vanda's ability to successfully resume the clinical programs that are currently on hold and the FDA's ability to complete its review of the HETLIOZ® applications for the treatment of SMS on time and make the determination that HETLIOZ® is safe and effective in the treatment of SMS in adults and children. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except for share and per share amounts)

    (unaudited)





    Three Months Ended



    Six Months Ended



    June 30

    2020



    June 30

    2019



    June 30

    2020



    June 30

    2019

    Revenues:















    HETLIOZ® net product sales

    $

    41,561





    $

    37,835





    $

    76,897





    $

    66,792



    Fanapt® net product sales

    20,646





    21,225





    43,310





    39,981



    Total revenues

    62,207





    59,060





    120,207





    106,773



    Operating expenses:















    Cost of goods sold excluding amortization

    5,847





    6,368





    11,054





    11,481



    Research and development

    12,903





    10,950





    28,430





    24,228



    Selling, general and administrative

    33,917





    31,468





    70,938





    62,497



    Intangible asset amortization

    369





    379





    739





    759



    Total operating expenses

    53,036





    49,165





    111,161





    98,965



    Income from operations

    9,171





    9,895





    9,046





    7,808



    Other income

    1,918





    1,649





    3,284





    3,134



    Income before income taxes

    11,089





    11,544





    12,330





    10,942



    Provision for income taxes

    2,375





    18





    3,130





    28



    Net income

    $

    8,714





    $

    11,526





    $

    9,200





    $

    10,914





    Net income per share, basic

    $

    0.16





    $

    0.22





    $

    0.17





    $

    0.21



    Net income per share, diluted

    $

    0.16





    $

    0.21





    $

    0.17





    $

    0.20





    Weighted average shares outstanding, basic

    54,501,308





    53,101,499





    54,153,812





    52,928,101



    Weighted average shares outstanding, diluted

    55,081,397





    54,579,982





    54,975,771





    54,932,932



     

     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    June 30,

    2020



    December 31,

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    95,305





    $

    45,072



    Marketable securities

    244,544





    267,057



    Accounts receivable, net

    24,587





    26,367



    Inventory

    1,384





    1,140



    Prepaid expenses and other current assets

    15,041





    14,500



    Total current assets

    380,861





    354,136



    Property and equipment, net

    3,744





    3,864



    Operating lease right-of-use assets

    10,601





    11,180



    Intangible assets, net

    22,298





    23,037



    Deferred tax assets

    85,558





    87,680



    Non-current inventory and other

    3,569





    3,851



    Total assets

    $

    506,631





    $

    483,748





    LIABILITIES AND STOCKHOLDERS' EQUITY

     







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    28,398





    $

    27,590



    Product revenue allowances

    33,194





    31,915



    Total current liabilities

    61,592





    59,505



    Operating lease non-current liabilities

    11,720





    12,455



    Other non-current liabilities

    1,735





    843



    Total liabilities

    75,047





    72,803



    Stockholders' equity:







    Common stock

    55





    54



    Additional paid-in capital

    642,398





    631,307



    Accumulated other comprehensive income

    596





    249



    Accumulated deficit

    (211,465)





    (220,665)



    Total stockholders' equity

    431,584





    410,945



    Total liabilities and stockholders' equity

    $

    506,631





    $

    483,748



     

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

     

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

     

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2020-financial-results-301106946.html

    SOURCE Vanda Pharmaceuticals Inc.

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  4. FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome

    WASHINGTON, Aug. 3, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS). The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

    "The FDA filing of the HETLIOZ® applications for priority review marks a major milestone and brings us closer to providing a critical…

    WASHINGTON, Aug. 3, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS). The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

    "The FDA filing of the HETLIOZ® applications for priority review marks a major milestone and brings us closer to providing a critical therapy to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. Currently, there are no approved treatments for patients with SMS, a rare orphan disorder affecting approximately 15,000 people in the U.S.

    About Smith-Magenis Syndrome

    Smith-Magenis Syndrome (SMS) is a developmental disorder that is caused by a small deletion of human chromosome 17p 1,2. In more rare cases SMS is caused by a point mutation in the RAI1 gene which resides in the deleted region. SMS is estimated to affect 1/15,000-25,000 births in the U.S.3  SMS is usually not inherited but rather is due to a de-novo deletion. Patients with SMS present with a number of physical, mental and behavioral problems. The most common symptom of SMS is a severe sleep disorder associated with significant disruption in the lives of patients and their families. 

    References:

    1. Williams, S. R., Zies, D., Mullegama, S. V, Grotewiel, M. S., & Elsea, S. H. (2012). Smith-Magenis syndrome results in disruption of CLOCK gene transcription and reveals an integral role for RAI1 in the maintenance of circadian rhythmicity. Am.J Hum.Genet., 90(1537–6605), 941–949.
    2. Gropman, A. L., Duncan, W. C., & Smith, A. C. (2006). Neurologic and developmental features of the Smith-Magenis syndrome (del 17p11.2). Pediatr.Neurol., 34(0887–8994), 337–350. 
    3. Orphanet ORPHA number 819.

    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 www.vandapharma.com and follow us on Twitter @vandapharma.

    About HETLIOZ®

    HETLIOZ® (tasimelteon) is a melatonin receptor agonist. HETLIOZ® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency. For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.

    HETLIOZ® IS NOT CURRENTLY APPROVED BY ANY REGULATORY AUTHORITY FOR THE TREATMENT OF SMS.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this release, including, but not limited to statements regarding the target completion date of the FDA's review of the sNDA and NDA for HETLIOZ® and Vanda's ability to make HETLIOZ® available to patients with SMS, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the ability of the FDA to complete its review of the applications on time and make the determination that HETLIOZ® is safe and effective in the treatment of SMS in adults and children. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/fda-accepts-and-grants-priority-review-of-vandas-applications-for-hetlioz-tasimelteon-in-the-treatment-of-smith-magenis-syndrome-301104479.html

    SOURCE Vanda Pharmaceuticals Inc.

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  5. Vanda Pharmaceuticals to Announce Second Quarter 2020 Financial Results on August 5, 2020

    WASHINGTON, July 29, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2020 on Wednesday, August 5, 2020, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, August 5, 2020, during which management will discuss the second quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary…

    WASHINGTON, July 29, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2020 on Wednesday, August 5, 2020, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, August 5, 2020, during which management will discuss the second quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    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 www.vandapharma.com and follow us on Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-second-quarter-2020-financial-results-on-august-5-2020-301102555.html

    SOURCE Vanda Pharmaceuticals Inc.

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