VNDA Vanda Pharmaceuticals Inc.

13.73
-0.25  -2%
Previous Close 13.98
Open 13.98
52 Week Low 7.12
52 Week High 15.95
Market Cap $750,916,409
Shares 54,691,654
Float 43,993,419
Enterprise Value $415,905,409
Volume 482,768
Av. Daily Volume 484,704
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Upcoming Catalysts

Drug Stage Catalyst Date
VSJ-110
Allergic Conjunctivitis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
Approved
Approved
FDA approval announced December 1, 2020.
Tradipitant
Gastroparesis
Phase 3
Phase 3
Phase 3 enrollment to be completed 1H 2021.
Tradipitant - EPIONE 2
Atopic dermatitis
Phase 3
Phase 3
Phase 3 enrolment commenced October 2019. On hold due to COVID-19.
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. WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for patients with SMS to sleep during the night. HETLIOZ® is the first FDA-approved medication for patients with SMS.

    "The FDA approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS would not have been accomplished without the heroic…

    WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for patients with SMS to sleep during the night. HETLIOZ® is the first FDA-approved medication for patients with SMS.

    "The FDA approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS would not have been accomplished without the heroic efforts of SMS patients and the efforts of their families and advocates supporting the recruitment, design, and conduct of the study," said Mihael H. Polymeropoulos M.D., Vanda's President and CEO. "We remain committed to providing this much needed therapy to patients with SMS."

    The approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS was based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the HETLIOZ® capsule and children with SMS taking the liquid formulation. The safety profile of HETLIOZ® in this study was similar to those seen in HETLIOZ® studies previously conducted for the treatment of Non-24-Hour Sleep-Wake Disorder, and was similar between adults and children with SMS.

    "We are very excited to see HETLIOZ®, the first ever treatment approved for people with SMS, addressing the significant problem of sleep disturbances and we are happy to see this treatment used in our community," said Maggie Miller, Co-Founder and Vice President of PRISMS (Parents and Researchers Interested in Smith-Magenis Syndrome).  "We thank Vanda and the FDA for partnering to help our community and we look forward to continued partnership to bring this important therapy to families with SMS."

    HETLIOZ® capsules, for adults with SMS, will be immediately available and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021.

    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.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this release, including, but not limited to statements regarding Vanda's ability to make HETLIOZ® available to patients with nighttime sleep disturbances in 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, market acceptance of HETLIOZ® as a treatment of SMS in adults and children, Vanda's dependence on third-party manufacturers to manufacture HETLIOZ® in sufficient quantities and quality, and Vanda's sales and marketing infrastructure. 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-approves-hetlioz-tasimelteon-for-the-treatment-of-nighttime-sleep-disturbances-in-smith-magenis-syndrome-301183162.html

    SOURCE Vanda Pharmaceuticals Inc.

    View Full Article Hide Full Article
  2. WASHINGTON, Oct. 28, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the third quarter ended September 30, 2020.

    "Vanda continued to deliver strong commercial performance in the third quarter, despite the ongoing COVID-19 pandemic, while at the same time we advanced our robust clinical development pipeline," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights 

    Third Quarter of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $60.3 million in the third quarter of 2020, a 1% increase compared to $59.5 million in the third quarter of 2019.
    • HETLIOZ® net product sales were $39.6 million in the third quarter of…

    WASHINGTON, Oct. 28, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the third quarter ended September 30, 2020.

    "Vanda continued to deliver strong commercial performance in the third quarter, despite the ongoing COVID-19 pandemic, while at the same time we advanced our robust clinical development pipeline," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights 

    Third Quarter of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $60.3 million in the third quarter of 2020, a 1% increase compared to $59.5 million in the third quarter of 2019.
    • HETLIOZ® net product sales were $39.6 million in the third quarter of 2020, a 5% increase compared to $37.6 million in the third quarter of 2019.
    • Fanapt® net product sales were $20.7 million in the third quarter of 2020, a 6% decrease compared to $21.9 million in the third quarter of 2019.
    • Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019.

    First Nine Months of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $180.5 million in the first nine months of 2020, a 9% increase compared to $166.3 million in the same period in 2019.
    • HETLIOZ® net product sales were $116.5 million in the first nine months of 2020, a 12% increase compared to $104.4 million in the same period in 2019.
    • Fanapt® net product sales were $64.0 million in the first nine months of 2020, a 3% increase compared to $61.9 million in the same period in 2019.
    • Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019.
    • Cash, cash equivalents and marketable securities (Cash) were $348.5 million as of September 30, 2020, representing an increase to Cash of $48.9 million compared to September 30, 2019.

    Key Product and Pipeline Highlights

    Products

    Vanda is encouraged by the strength of its commercial performance during the third quarter of 2020 despite the COVID-19 pandemic. 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 Fanapt® for schizophrenia direct-to-consumer campaign, which was launched at the end of the second quarter of 2020.

    Pipeline

    The COVID-19 pandemic has impacted clinical research globally, including some of Vanda's previously reported clinical trials. The tradipitant gastroparesis program has resumed patient enrollment, while randomization for the tradipitant motion sickness and atopic dermatitis programs, as well as the Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.

    Tradipitant

    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study reached 50% enrollment towards a target of 200 randomized patients and is expected to complete enrollment in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
    • Interim analysis from the Phase III clinical study (ODYSSEY VLY-686-3501) shows that tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia.1 Vanda continues to recruit patients for this study.

    HETLIOZ® (tasimelteon)

    • The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the U.S. Food and Drug Administration (FDA) for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of December 1, 2020.2

    VSJ-110 (previously known as CFTRact-K267)

    • The Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 for the treatment of allergic conjunctivitis was approved by the FDA.3

    Key Publications

    • The article "Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study" was published in the September 2020 issue of Frontiers in Neurology.4

    GAAP Financial Results

    Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019. Net income was $5.9 million in the third quarter of 2020, compared to net income of $100.4 million in the third quarter of 2019. Diluted net income per share was $0.11 in the third quarter of 2020, compared to diluted net income per share of $1.84 in the third quarter of 2019.

    Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019. Net income was $15.1 million in the first nine months of 2020, compared to net income of $111.3 million in the same period in 2019. Diluted net income per share was $0.28 in the first nine months of 2020, compared to diluted net income per share of $2.03 in the same period in 2019.

    The income tax benefit of $88.1 million reflected in the financial results for both the third quarter of 2019 and the first nine months of 2019 includes the favorable impact of the release of Vanda's deferred tax asset valuation allowance.

    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.

    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

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, October 28, 2020, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 8971955. A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

    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 "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
    2. 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
    3. Refer to Company press release titled "Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VSJ-110 for Allergic Conjunctivitis" issued on October 26, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14286/pdf
    4. Polymeropoulos, V.M., Czeisler, M.E., Gibson, M.M., Anderson, A.A., Miglo, J., Wang, J., Xiao, C., Polymeropoulos, C.M., Birznieks, G., & Polymeropoulos, M. H. (2020). Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. Frontiers in Neurology, 11, p. 563373. https://doi.org/10.3389/fneur.2020.563373

    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 marketing and sales strategies, recruitment for the gastroparesis and ODYSSEY studies, the interim analysis from the ODYSSEY study 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 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 pneumonia; 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



    Nine Months Ended



    September 30

    2020



    September 30

    2019



    September 30

    2020



    September 30

    2019

    Revenues:















    HETLIOZ® net product sales

    $

    39,618





    $

    37,589





    $

    116,515





    $

    104,381



    Fanapt® net product sales

    20,690





    21,896





    64,000





    61,877



    Total revenues

    60,308





    59,485





    180,515





    166,258



    Operating expenses:















    Cost of goods sold excluding amortization

    5,898





    6,782





    16,952





    18,263



    Research and development

    12,298





    11,347





    40,728





    35,575



    Selling, general and administrative

    34,001





    30,221





    104,939





    92,718



    Intangible asset amortization

    369





    376





    1,108





    1,135



    Total operating expenses

    52,566





    48,726





    163,727





    147,691



    Income from operations

    7,742





    10,759





    16,788





    18,567



    Other income

    659





    1,517





    3,943





    4,651



    Income before income taxes

    8,401





    12,276





    20,731





    23,218



    Provision (benefit) for income taxes

    2,454





    (88,147)





    5,584





    (88,119)



    Net income

    $

    5,947





    $

    100,423





    $

    15,147





    $

    111,337



    Net income per share, basic

    $

    0.11





    $

    1.88





    $

    0.28





    $

    2.10



    Net income per share, diluted

    $

    0.11





    $

    1.84





    $

    0.28





    $

    2.03



    Weighted average shares outstanding, basic

    54,666,128





    53,297,298





    54,325,832





    53,052,521



    Weighted average shares outstanding, diluted

    55,209,032





    54,541,625





    55,054,772





    54,803,851



     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    September 30

    2020



    December 31

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    56,973





    $

    45,072



    Marketable securities

    291,575





    267,057



    Accounts receivable, net

    28,033





    26,367



    Inventory

    1,322





    1,140



    Prepaid expenses and other current assets

    11,631





    14,500



    Total current assets

    389,534





    354,136



    Property and equipment, net

    3,921





    3,864



    Operating lease right-of-use assets

    10,306





    11,180



    Intangible assets, net

    21,929





    23,037



    Deferred tax assets

    83,858





    87,680



    Non-current inventory and other

    6,357





    3,851



    Total assets

    $

    515,905





    $

    483,748



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    29,086





    $

    27,590



    Product revenue allowances

    32,273





    31,915



    Total current liabilities

    61,359





    59,505



    Operating lease non-current liabilities

    11,559





    12,455



    Other non-current liabilities

    2,415





    843



    Total liabilities

    75,333





    72,803



    Stockholders' equity:







    Common stock

    55





    54



    Additional paid-in capital

    645,656





    631,307



    Accumulated other comprehensive income

    379





    249



    Accumulated deficit

    (205,518)





    (220,665)



    Total stockholders' equity

    440,572





    410,945



    Total liabilities and stockholders' equity

    $

    515,905





    $

    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-third-quarter-2020-financial-results-301162148.html

    SOURCE Vanda Pharmaceuticals Inc.

    View Full Article Hide Full Article
  3. WASHINGTON, Oct. 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as CFTRact-K267) for the treatment of allergic conjunctivitis.

    "This is an exciting milestone in the course of our collaboration with University of California, San Francisco (UCSF) and Dr. Alan Verkman towards the development of human therapeutics targeting the Cystic Fibrosis Transmembrane Conductance Regulator," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.  "Initiation of the clinical program for VSJ-110…

    WASHINGTON, Oct. 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as CFTRact-K267) for the treatment of allergic conjunctivitis.

    "This is an exciting milestone in the course of our collaboration with University of California, San Francisco (UCSF) and Dr. Alan Verkman towards the development of human therapeutics targeting the Cystic Fibrosis Transmembrane Conductance Regulator," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.  "Initiation of the clinical program for VSJ-110 marks the beginning of Vanda's development of therapeutics in ophthalmology exploring the compound's novel dual anti-inflammatory and prosecretory mechanism of action."

    The initial Phase II study in human volunteers will evaluate the acute anti-inflammatory effects of VSJ-110 in an ocular allergic challenge model, and will evaluate the prosecretory effects using standard tear production assessments.

    The results from this Phase II study will help guide further development of VSJ-110 to treat a variety of ocular inflammatory conditions, including dry eye, which has an estimated worldwide prevalence of 5-20%, with about 16 million affected individuals in the United States.1 Other potential indications include chronic inflammatory eye conditions, such as atopic keratoconjunctivitis, which remain poorly addressed with current treatment options.2

    "Studies in experimental animal models already provide in vivo evidence for the efficacy of CFTRact-K267 (VSJ-110) in stimulating chloride secretion and reversing corneal epithelial injury in dry eye," said Alan Verkman, M.D., Ph.D., Professor of Medicine at UCSF.

    "It is exciting to see Vanda pursue a unique and novel therapeutic mechanism of action to address common inflammatory eye conditions that impact such a significant number of patients," said Julie Schallhorn, M.D., M.S., Assistant Professor of Ophthalmology at UCSF. "The mechanism of action of VSJ-110, that could address both the aqueous deficiency and inflammatory components of dry eye disease, has the potential to revolutionize how we care for dry eye patients."

    Vanda plans to initiate enrollment in the Phase II study by the end of 2020 and anticipates results of this study in 2021.

    About VSJ-11

    VSJ-110 is a small molecule nanomolar potency CFTR activator. VSJ-110 has shown efficacy in a dry eye model3 and exhibited anti-inflammatory properties in both in vitro and in vivo assays.

    Vanda entered into a license agreement with UCSF in 2017, under which Vanda acquired an exclusive worldwide license from UCSF to develop and commercialize a portfolio of CFTR activators and inhibitors, including VSJ-110. CFTR activators and inhibitors may have broad applicability in addressing a number of disorders, including chronic dry eye, constipation, polycystic kidney disease, cholestasis, and secretory diarrheas.

    References

    1. Stapleton, F., Alves, M., Bunya, V. Y., Jalbert, I., Lekhanont, K., Malet, F., Na, K. S., Schaumberg, D., Uchino, M., Vehof, J., Viso, E., Vitale, S., & Jones, L. (2017). TFOS DEWS II Epidemiology Report. The ocular surface, 15(3), 334–365. https://doi.org/10.1016/j.jtos.2017.05.003
    2. Pedram, H., Reza, D. (2019, September). Vernal keratoconjunctivitis. UpToDate. https://www.uptodate.com/contents/vernal-keratoconjunctivitis.
    3. Chen, X., Lee, S., Zhang, T., Duan, T., Pasricha, N. D., Schallhorn, J. M., Levin, M. H., Koprivica, V., & Verkman, A. S. (2020). Nanomolar Potency Aminophenyltriazine CFTR Activator Reverses Corneal Epithelial Injury in a Mouse Model of Dry Eye. Journal of ocular pharmacology and therapeutics: the official journal of the Association for Ocular Pharmacology and Therapeutics, 36(3), 147–153. https://doi.org/10.1089/jop.2019.0087

    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 VSJ-110 clinical development program, the timeline and anticipated findings of the VSJ-110 Phase II study, the potential for VSJ-110 to be a safe and effective treatment for patients with allergic conjunctivitis, dry eye and atopic keratoconjunctivitis, 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 enroll patients for, and successfully conduct, the VSJ-110 Phase II study for the treatment of allergic conjunctivitis in the midst of the global COVID-19 pandemic; Vanda's ability to enroll patients for, and successfully conduct, studies of VSJ-110 in additional indications; Vanda's ability to complete the clinical development of and obtain regulatory approval of VSJ-110 for the treatment of allergic conjunctivitis and additional indications. 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:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-receives-fda-approval-to-proceed-with-investigational-new-drug-vsj-110-for-allergic-conjunctivitis-301159858.html

    SOURCE Vanda Pharmaceuticals Inc.

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  4. WASHINGTON, Oct. 21, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the third quarter 2020 on Wednesday, October 28, 2020, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, October 28, 2020, during which management will discuss the third quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 8971955.

    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…

    WASHINGTON, Oct. 21, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the third quarter 2020 on Wednesday, October 28, 2020, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, October 28, 2020, during which management will discuss the third quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 8971955.

    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.

    A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

    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-third-quarter-2020-financial-results-on-october-28-2020-301157388.html

    SOURCE Vanda Pharmaceuticals Inc.

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  5. Appointment Adds Two Additional Independent, Highly Qualified, Diverse Directors

    Spectrum Brands Holdings, Inc. (NYSE:SPB, "Spectrum Brands" or the "Company"))), a leading global branded consumer products and home essentials company focused on driving innovation and providing exceptional customer service, today announced the appointments of Gautam Patel and Anne S. Ward to its Board of Directors, each an independent, highly qualified, and diverse background candidate.

    "We are very pleased to welcome Gautam and Anne as our new independent directors. They join our team during an exciting time as a home essentials company. We look forward to drawing on Gautam's extensive knowledge in mergers and acquisitions, financings, and investments across…

    Appointment Adds Two Additional Independent, Highly Qualified, Diverse Directors

    Spectrum Brands Holdings, Inc. (NYSE:SPB, "Spectrum Brands" or the "Company"))), a leading global branded consumer products and home essentials company focused on driving innovation and providing exceptional customer service, today announced the appointments of Gautam Patel and Anne S. Ward to its Board of Directors, each an independent, highly qualified, and diverse background candidate.

    "We are very pleased to welcome Gautam and Anne as our new independent directors. They join our team during an exciting time as a home essentials company. We look forward to drawing on Gautam's extensive knowledge in mergers and acquisitions, financings, and investments across a broad range of sectors and Anne's extensive knowledge in personal care and home essential products across a broad range of consumer brands. Their backgrounds and experiences complement and enhance the skillset of our Board and provide additional resources to our management team. Their additions to our Board also reflect the dialogue we had with our shareholders and our commitment to having a highly skilled Board with a significant variety of expertise and experiences and diversity across race, gender, and ethnicity," said David Maura, Chairman and Chief Executive Offer of Spectrum Brands.

    In addition, as part of the Company's shareholder engagement program and its commitment to improved corporate governance, the Board also adopted a Board Diversity Policy. A copy of this policy can be found on the Company's website at www.spectrumbrands.com under "Investor Relations-Corporate Governance Documents".

    Mr. Gautam Patel, age 48, serves as Managing Director of Tarsadia Investments, a private investment firm based in Newport Beach, California, which he joined in 2012. In that role, Mr. Patel has led a team of investment professionals to identify, evaluate, and execute principal control equity investments across sectors including life sciences, financial services, and technology. Prior to joining Tarsadia in 2012, Mr. Patel served as Managing Director at Lazard, where he led financial and strategic advisory efforts in sectors including transportation and logistics, private equity, and healthcare. Mr. Patel joined Lazard as an associate in 1999, after graduating from business school. From 1994 to 1997, Mr. Patel was an Analyst at Donaldson, Lufkin & Jenrette, where he worked on mergers and acquisitions as well as high-yield and equity financings. Mr. Patel is currently a Board Member of Amneal Pharmaceuticals (NYSE:AMRX) as well as several private companies including Kashiv Biosciences, Asana Biosciences, Prolong Pharmaceuticals, LERETA and AIONX Antimicrobial Technologies. Mr. Patel also serves on the board of Casita Maria Center for Arts and Education, a New York based non-profit organization which aims to empower children through arts based education. Mr. Patel received a B.A. from Claremont McKenna College, a B.S. from Harvey Mudd College, an MSc from the London School of Economics and an MBA from the University of Chicago.

    Ms. Anne Ward, age 48, currently serves as the Chief Executive Officer of CURiO Brands, a privately-held consumer goods company that manufactures and sells a portfolio of personal care and home fragrance brands. She joined the company in April 2012 as the CEO of Thymes and subsequently led a merger with DPM Fragrance to form CURiO. Prior to CURiO, Ms. Ward founded The FORWARD Group, a consulting firm focused on developing growth strategies for mid-sized companies and key executives, and served as its CEO from July 2010 until April 2012. From October 2007 until July 2010, Ms. Ward was the President and Chief Operating Officer of Johnson Publishing Company where she led the Ebony, Jet and Fashion Fair Cosmetics business units. Prior to her role at Johnson Publishing Company, Ms. Ward served as an Assistant Vice President of marketing for The Coca-Cola Company from September 2006 until September 2007 leading growth strategies for Coca-Cola, Sprite, Dasani and other key brands. Ms. Ward also held several positions of increasing responsibility within manufacturing and brand management at Procter & Gamble between May 1994 and August 2006. She led well-established, global brands including Pampers and Clairol as well as consumer growth strategies for the Beauty division. Ms. Ward currently serves as a Board Member of Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA). She holds a B.S. in Mechanical Engineering and Material Science from Duke University and an M.B.A. from Duke University's Fuqua School of Business.

    About Spectrum Brands Holdings, Inc.

    Spectrum Brands Holdings, a member of the Russell 1000 Index, is a leading supplier of residential locksets, residential builders' hardware, plumbing, shaving and grooming products, personal care products, small household appliances, specialty pet supplies, lawn and garden and home pest control products, and personal insect repellents. Helping to meet the needs of consumers worldwide, Spectrum Brands offers a broad portfolio of market-leading, well-known and widely trusted brands including Kwikset®, Weiser®, Baldwin®, National Hardware®, Pfister®, Remington®, George Foreman®, Russell Hobbs®, Black+Decker®, Tetra®, Marineland®, Nature's Miracle®, Dingo®, 8-in-1®, FURminator®, IAMS® and Eukanuba® (Europe only), Digest-eeze™, Healthy-Hide®, Littermaid®, Spectracide®, Cutter®, Repel®, Hot Shot®, Black Flag® and Liquid Fence®. For more information, please visit www.spectrumbrands.com. Spectrum Brands – A Home Essentials Company.

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