TVTX Travere Therapeutics Inc.

22.51
+0.07  (+0%)
Previous Close 22.44
Open 22.7
52 Week Low 12.75
52 Week High 33.0899
Market Cap $1,366,743,632
Shares 60,717,176
Float 60,239,404
Enterprise Value $1,060,564,429
Volume 3,000,828
Av. Daily Volume 1,399,160
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Upcoming Catalysts

Drug Stage Catalyst Date
Pegtibatinase (TVT-058)
Classical homocystinuria (HCU)
Phase 1/2
Phase 1/2
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Sparsentan (DUPLEX)
Focal segmental glomerulosclerosis (FSGS)
Phase 3
Phase 3
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Sparsentan (PROTECT)
IgA nephropathy
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
THIOLA EC (tiopronin)
Cystinuria
Approved
Approved
FDA Approval announced June 28, 2019.
CHOLBAM (cholic acid)
Rare Bile Acid Synthesis Disorders
Approved
Approved
Approved Mar 18 2015
CNSA-001
Phenylketonuria (PKU)
Phase 2
Phase 2
Development to be discontinued - noted August 6, 2019.
Fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)
Phase 3
Phase 3
Phase 3 top-line data did not meet endpoints - August 22, 2019.
Chenodal (chenodeoxycholic acid)
Cerebrotendinous xanthomatosis (CTX).
Phase 3
Phase 3
Phase 3 patients have been randomized - noted February 24, 2020.

Latest News

    • Sparsentan is a potential first-in-class treatment to address significant unmet medical need in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)
    • Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand
    • Travere receives a USD 55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005966/en/

    AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    Vifor Pharma Group and Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced the companies have entered…

    • Sparsentan is a potential first-in-class treatment to address significant unmet medical need in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)
    • Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand
    • Travere receives a USD 55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005966/en/

    AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    Vifor Pharma Group and Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand. Sparsentan is a novel investigational product candidate currently being evaluated in pivotal phase-III clinical studies for the treatment of FSGS and IgAN, two rare progressive kidney disorders and leading causes of end-stage kidney disease. There are currently no approved medicines indicated for FSGS or IgAN. Sparsentan has been granted Orphan Drug Designation for the treatment of IgAN and FSGS in the U.S. and Europe.

    Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. Travere will receive an upfront payment of USD 55 million and be eligible for up to USD 135 million in payments tied to the achievement of certain regulatory and market access related milestones. Vifor Pharma will also make further payments in the form of sales milestones, and tiered double-digit royalties on net sales of sparsentan in Europe, Australia and New Zealand up to 40 percent at the high end of the royalty range.

    "This agreement highlights that Vifor Pharma has become a company of choice for organizations committed to partnering innovative nephrology assets", Abbas Hussain, CEO of Vifor Pharma Group commented. "With sparsentan, we will further expand our growing nephrology pipeline into FSGS and IgAN. There are currently no effective or approved therapies for these two rare kidney disorders, resulting in a significant unmet medical need among these patient populations. We look forward to working closely with Travere, who is responsible for the ongoing clinical development program of sparsentan, and to leveraging our commercial expertise to bring this highly promising, innovative treatment option to potentially more than 150,000 patients living with IgAN or FSGS in the licensed territories as soon as possible."

    "Our goal is for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; this collaboration marks an important step forward in this journey," said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. "Vifor Pharma is a global leader in nephrology with established commercialization expertise in Europe, Australia and New Zealand and this agreement aligns our two companies with the common goal of maximizing the number of people who can access sparsentan, if approved in these regions. In addition, this collaboration will further strengthen our financial foundation and allow our organization to focus on planned future launches of sparsentan in the U.S."

    Following the recently announced positive topline interim results from the ongoing pivotal phase-III PROTECT study of sparsentan in IgAN, Travere and Vifor Pharma will further evaluate the regulatory strategy for sparsentan in Europe, including the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022. Ultimately, the responsibility for and control over marketing authorizations in the licensed territories will be transitioned to Vifor Pharma. If sparsentan is approved, Vifor Pharma will be responsible for all commercialization activities in the licensed territories. Travere remains responsible for the clinical development of sparsentan and will retain all rights to sparsentan in the U.S. and rest of the world.

    About Vifor Pharma Group 

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF).

    For more information, please visit viforpharma.com.

    About Travere Therapeutics 

    At Travere Therapeutics we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.

    About sparsentan 

    Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.

    Sparsentan is currently being evaluated in the pivotal phase-III DUPLEX study for the treatment of FSGS and the pivotal phase-III PROTECT study for the treatment of IgAN. In February 2021, Travere announced that the ongoing DUPLEX study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, Travere announced that the ongoing PROTECT study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and performed consistent with the observed safety profile to date. In the phase-II DUET study of sparsentan in FSGS, the combined treatment group met its primary efficacy endpoint, demonstrating a greater than two-fold reduction in proteinuria compared to irbesartan, and was generally well tolerated after the eight-week, double-blind treatment period. Irbesartan is part of a class of drugs used to manage FSGS and IgAN in the absence of an approved pharmacologic treatment. If approved for both indications, sparsentan could potentially be the first medicine approved for both FSGS and IgAN.

    Forward Looking Statements 

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: Travere's goal for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; the goal to maximize the number of people who can access sparsentan, if approved in the licensed regions; the ability of the collaboration to further strengthen Travere's financial foundation; planned future launches of sparsentan in the U.S.; the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022; Vifor's potential future achievement of regulatory, market-access and sales based milestones and Travere's potential future receipt of payments therefrom; statements regarding the projected patient population in the licensed territory if sparsentan is approved; references to the efficacy, safety and tolerability profile of sparsentan based on the preliminary data from the DUPLEX and PROTECT Studies' interim analyses; and the potential for sparsentan to become the first medicine approved for both FSGS and IgAN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the conditional marketing authorization pathway in Europe, and the pricing and reimbursement landscape in the licensed territories, as well as ongoing clinical development risk. There is no guarantee that regulatory authorities in the licensed territories will accept a marketing authorization application for sparsentan or that sparsentan will receive conditional marketing authorization or be approved at all. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. Travere undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in Travere's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

    View Full Article Hide Full Article
  1. Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand

    Travere receives a $55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales

    Sparsentan is a potential first-in-class treatment to address significant unmet medical needs in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)

    SAN DIEGO and ST GALLEN, Switzerland, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) and Vifor Pharma today announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New…

    Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand

    Travere receives a $55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales

    Sparsentan is a potential first-in-class treatment to address significant unmet medical needs in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)

    SAN DIEGO and ST GALLEN, Switzerland, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) and Vifor Pharma today announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand. Sparsentan is a novel investigational product candidate currently being evaluated in pivotal Phase 3 clinical studies for the treatment of FSGS and IgAN, two rare progressive kidney disorders and leading causes of end-stage kidney disease. There are currently no approved medicines indicated for FSGS or IgAN. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.

    Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. Travere will receive an upfront payment of $55 million and be eligible for up to $135 million in payments tied to the achievement of certain regulatory and market access related milestones. Vifor Pharma will also make further payments in the form of sales milestones, and tiered double-digit royalties on net sales of sparsentan in Europe, Australia and New Zealand up to 40 percent at the high end of the royalty range.

    "Our goal is for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; this collaboration marks an important step forward in this journey," said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. "Vifor Pharma is a global leader in nephrology with established commercialization expertise in Europe, Australia and New Zealand and this agreement aligns our two companies with the common goal of maximizing the number of people who can access sparsentan, if approved in these regions. In addition, this collaboration will further strengthen our financial foundation and allow our organization to focus on planned future launches of sparsentan in the U.S."

    "This agreement highlights that Vifor Pharma has become a company of choice for organizations committed to partnering innovative nephrology assets," Abbas Hussain, chief executive officer of Vifor Pharma Group commented. "With sparsentan, we will further expand our growing nephrology pipeline into FSGS and IgAN. There are currently no effective or approved therapies for these two rare kidney disorders, resulting in a significant unmet medical need among these patient populations. We look forward to working closely with Travere, who is responsible for the ongoing clinical development program of sparsentan, and to leveraging our commercial expertise to bring this highly promising, innovative treatment option to more than 150,000 patients living with FSGS and IgAN in the licensed territories as soon as possible."

    Following the recently announced positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgAN, Travere and Vifor Pharma will further evaluate the regulatory strategy for sparsentan in Europe, including the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022. Ultimately, the responsibility for and control over marketing authorizations in the licensed territories will be transitioned to Vifor Pharma. If sparsentan is approved, Vifor Pharma will be responsible for all commercialization activities in the licensed territories. Travere remains responsible for the clinical development of sparsentan and will retain all rights to sparsentan in the United States and rest of world. Travere remains obligated to make payments to Ligand Pharmaceuticals upon achievement of certain regulatory and sales milestones, as well as an escalating annual royalty between 15 percent and 17 percent of global net product sales.

    About Sparsentan

    Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.

    Sparsentan is currently being evaluated in the pivotal Phase 3 DUPLEX Study for the treatment of FSGS and the pivotal Phase 3 PROTECT Study for the treatment of IgAN. In February 2021, the Company announced that the ongoing DUPLEX Study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, the Company announced that the ongoing PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and performed consistent with the observed safety profile to date. In the Phase 2 DUET Study of sparsentan in FSGS, the combined treatment group met its primary efficacy endpoint, demonstrating a greater than two-fold reduction in proteinuria compared to irbesartan, and was generally well tolerated after the eight-week, double-blind treatment period. Irbesartan is part of a class of drugs used to manage FSGS and IgAN in the absence of an approved pharmacologic treatment. If approved for both indications, sparsentan could potentially be the first medicine approved for both FSGS and IgAN.

    About Travere Therapeutics

    At Travere Therapeutics we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow.

    For more information, visit travere.com

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF).

    For more information, please visit viforpharma.com.

    Forward Looking Statements

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: Travere's goal for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; the goal to maximize the number of people who can access sparsentan, if approved in the licensed regions; the ability of the collaboration to further strengthen Travere's financial foundation; planned future launches of sparsentan in the U.S.; the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022; Vifor's potential future achievement of regulatory, market-access and sales based milestones and Travere's potential future receipt of payments therefrom; statements regarding the projected patient population in the licensed territory if sparsentan is approved; references to the efficacy, safety and tolerability profile of sparsentan based on the preliminary data from the DUPLEX and PROTECT Studies' interim analyses; and the potential for sparsentan to become the first medicine approved for both FSGS and IgAN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the conditional marketing authorization pathway in Europe, and the pricing and reimbursement landscape in the licensed territories, as well as ongoing clinical development risk. There is no guarantee that regulatory authorities in the licensed territories will accept a marketing authorization application for sparsentan or that sparsentan will receive conditional marketing authorization or be approved at all. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. Travere undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in Travere's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

     
    Contact:



    Travere Therapeutics:

    Chris Cline, CFA                                 

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879                                        

    IR@travere.com        



    Vifor Pharma:
    Media Relations

    Nathalie Ponnier

    Global Head Corporate Communications

    +41 79 957 96 73

    media@viforpharma.com
    Investor Relations

    Julien Vignot

    Head of Investor Relations

    +41 58 851 66 90

    investors@viforpharma.com



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  2. SAN DIEGO, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced the appointment of Ruth Williams-Brinkley to the Company's Board of Directors, effective immediately. Ms. Williams-Brinkley brings to Travere more than 35 years of executive leadership in care delivery and health plan operations.

    "On behalf of the Board of Directors, I am pleased to welcome Ruth to Travere," said Gary Lyons, chairman of the Travere Therapeutics Board of Directors. "She is a distinguished leader with extensive experience in the delivery of care and is an actively engaged and admired community leader. As we look to future potential commercial launches from our pipeline, Ruth's insights will be instrumental in achieving our…

    SAN DIEGO, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced the appointment of Ruth Williams-Brinkley to the Company's Board of Directors, effective immediately. Ms. Williams-Brinkley brings to Travere more than 35 years of executive leadership in care delivery and health plan operations.

    "On behalf of the Board of Directors, I am pleased to welcome Ruth to Travere," said Gary Lyons, chairman of the Travere Therapeutics Board of Directors. "She is a distinguished leader with extensive experience in the delivery of care and is an actively engaged and admired community leader. As we look to future potential commercial launches from our pipeline, Ruth's insights will be instrumental in achieving our goal of enabling broad access to our innovative therapies."

    Ms. Williams-Brinkley added: "This is an exciting time to join the board of Travere as the organization advances towards delivering new treatment options for people living with rare kidney conditions, many of whom have been significantly underserved for decades. I am proud to be joining a company that cares deeply about the patients and caregivers it serves, and is a champion for diversity, health equity and inclusion in the rare disease community."

    Ms. Williams-Brinkley has served as President of the Kaiser Foundation Health Plan for the Mid-Atlantic States since 2020, overseeing all of Kaiser Permanente's care delivery and health plan operations in Washington, D.C., and suburban Maryland, Baltimore, and Northern Virginia. Kaiser Permanente's Mid-Atlantic States region operates 34 medical offices and has 789,030 members. She joined Kaiser Permanente in 2017 as President of Kaiser Foundation Health Plan and Hospitals of the Northwest, in Portland, Oregon. Prior to her roles at Kaiser Permanente, Ms. Williams-Brinkley served as CEO of KentuckyOne Health, Kentucky's largest integrated health system. KentuckyOne was a division of CommonSpirit Health, one of the nation's largest nonprofit health systems. Before joining KentuckyOne Health, Ms. Williams-Brinkley served as president and CEO of Carondelet Health Network in Tucson, Arizona, and as president and CEO of Memorial Healthcare System in Chattanooga, Tennessee.

    Ms. Williams-Brinkley has repeatedly appeared on Modern Healthcare's "Top 25 Women in Healthcare" and "Top 25 Minority Executives in Healthcare" lists, and she was named by Modern Healthcare as one of "2020's 100 Most Influential People". In addition, Ms. Williams-Brinkley has been named one of Becker's Hospital Review's "Most Admired CEOs". Ms. Williams-Brinkley serves on the not-for-profit Boards of DePaul University in Chicago, Illinois and the Clinical Center Research Hospital Board of the National Institutes of Health (NIH) in Washington, D.C., as well as on the Board of Directors of University of Phoenix. She holds a bachelor's degree and a master's of science degree in nursing from DePaul University, and she has an honorary doctoral degree from Spaulding University, Louisville, Ky. Ms. Williams-Brinkley is also a Fellow of the American College of Healthcare Executives (FACHE).

    About Travere Therapeutics

    At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com

    Forward Looking Statements

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to future potential commercial launches from the Company's pipeline and the Company's ability to achieve its goal of enabling broad access to its innovative therapies. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the Subpart H accelerated approval pathway in the United States and the conditional marketing authorization (CMA) pathway in Europe. Specifically, the Company faces the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned; risk that the Phase 3 PROTECT Study of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan as planned; and risk that sparsentan will not be approved for efficacy, safety, regulatory or other reasons, and for each of the Company's programs, risk associated with enrollment of clinical trials for rare diseases and risk that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products. The Company faces additional risks associated with the potential impacts the COVID-19 pandemic may have on its business, including, but not limited to (i) the Company's ability to continue its ongoing development activities and clinical trials, (ii) the timing of such clinical trials and the release of data from those trials, (iii) the Company's and its suppliers' ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of its commercial products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's most recent Form 10-Q, Form 10-K and other filings with the Securities and Exchange Commission.

    Contact:

    Chris Cline, CFA

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879

    IR@travere.com 

     



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  3. SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced that on September 10, 2021, the Compensation Committee of its Board of Directors granted inducement equity grants covering an aggregate of 48,100 shares of its common stock to five new employees, consisting of inducement stock options to purchase an aggregate of 40,500 shares of common stock and inducement restricted stock units, or RSUs, covering an aggregate of 7,600 shares of its common stock. These inducement stock options and inducement RSUs are subject to the terms of Travere's 2018 Equity Incentive Plan ("2018 Plan"), but were granted outside of the 2018 Plan and were granted as inducements material to the new employees entering into…

    SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced that on September 10, 2021, the Compensation Committee of its Board of Directors granted inducement equity grants covering an aggregate of 48,100 shares of its common stock to five new employees, consisting of inducement stock options to purchase an aggregate of 40,500 shares of common stock and inducement restricted stock units, or RSUs, covering an aggregate of 7,600 shares of its common stock. These inducement stock options and inducement RSUs are subject to the terms of Travere's 2018 Equity Incentive Plan ("2018 Plan"), but were granted outside of the 2018 Plan and were granted as inducements material to the new employees entering into employment with Travere in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock options have an exercise price of $23.55 per share, the closing price of Travere's common stock on the date of grant, are non-qualified stock options, have a 10-year term and vest over four years, with 25% of the shares vesting on the one-year anniversary of the grant date and the remaining 75% of the shares vesting in equal monthly installments over the following 36 months, subject to the new employee's continued service relationship with Travere through the applicable vesting dates.

    The RSUs vest over four years, with 25% of the shares vesting on each anniversary of the grant date, subject to the new employee's continued service relationship with Travere through the applicable vesting dates.

    About Travere Therapeutics

    At Travere Therapeutics we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com

    Contact:

    Chris Cline, CFA                                 

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879                                        

    IR@travere.com



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  4. SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced a successful outcome from the Company's Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the Company's plan to submit additional estimated glomerular filtration rate (eGFR) data from the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) to support an application for accelerated approval in 2022.

    "We are very pleased with the outcome of the Type A meeting which confirms our plan to provide FDA with additional eGFR data from the ongoing DUPLEX Study in the first half of 2022 to continue on the accelerated approval pathway for sparsentan in FSGS…

    SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced a successful outcome from the Company's Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the Company's plan to submit additional estimated glomerular filtration rate (eGFR) data from the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) to support an application for accelerated approval in 2022.

    "We are very pleased with the outcome of the Type A meeting which confirms our plan to provide FDA with additional eGFR data from the ongoing DUPLEX Study in the first half of 2022 to continue on the accelerated approval pathway for sparsentan in FSGS," said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. "If the additional data further strengthen the prediction of long-term benefit in the study as we expect, we anticipate submitting a New Drug Application for accelerated approval of sparsentan for FSGS in the middle of next year and furthering our preparations to deliver it as a potential new treatment standard for FSGS, if approved."

    Following the outcome of the Type A meeting, the Company intends to continue with its plan to provide the FDA with additional eGFR data from the ongoing DUPLEX Study in the first half of 2022. At the time of the eGFR data cut, all patients remaining in the DUPLEX Study will have completed one year of treatment, and approximately 50 percent of patients will have completed two years of treatment. The Company plans to submit an application for accelerated approval in the U.S. in mid-2022, pending additional supportive eGFR data. The DUPLEX Study is continuing as planned with no changes to the statistical analysis plan, and patients will proceed in a blinded manner to assess the treatment effect on eGFR slope over 108 weeks in the confirmatory endpoint analysis.

    About Sparsentan

    Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.

    Sparsentan is currently being evaluated in the pivotal Phase 3 DUPLEX Study for the treatment of focal segmental glomerulosclerosis (FSGS) and the pivotal Phase 3 PROTECT Study for the treatment of IgAN. In February 2021, the Company announced that the ongoing DUPLEX Study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, the Company announced that the ongoing PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and performed consistent with the observed safety profile to date. In the Phase 2 DUET Study of sparsentan in FSGS, the combined treatment group met its primary efficacy endpoint, demonstrating a greater than two-fold reduction in proteinuria compared to irbesartan, and was generally well tolerated after the eight-week, double-blind treatment period. Irbesartan is part of a class of drugs used to manage FSGS and IgAN in the absence of an approved pharmacologic treatment. If approved for both indications, sparsentan could potentially be the first medicine approved for both FSGS and IgAN.

    About Travere Therapeutics

    At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com

    Forward Looking Statements

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: the Company's expected timing and plan for the data cut for the additional eGFR data from the DUPLEX Study; the Company's expectation that the additional data should further strengthen the prediction of long-term benefit in the DUPLEX study; the expectation of  submitting an application for accelerated approval of sparsentan for FSGS in mid-2022, pending the additional eGFR data; the Company's expectations to further its preparations to deliver sparsentan as a potential new treatment standard for FSGS, if approved; expectations regarding the future conduct of the ongoing DUPLEX study and timing for topline results from the confirmatory endpoint analysis; references to the efficacy, safety and tolerability profile of sparsentan based on the preliminary data from the DUPLEX and PROTECT Studies' interim analyses; and the potential for sparsentan to become the first medicine approved for both FSGS and IgAN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the Subpart H accelerated approval pathway, and the risk that the additional eGFR data will not support an accelerated approval submission. Specifically, the Company faces the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned; risk that the Phase 3 PROTECT Study of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan as planned; and risk that sparsentan will not be approved for efficacy, safety, regulatory or other reasons, and for each of the Company's programs, risk associated with enrollment of clinical trials for rare diseases and risk that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. There is no guarantee that the planned eGFR data cut will provide sufficient additional support for an accelerated approval submission for sparsentan in FSGS, that the FDA will accept for filing a NDA for sparsentan for FSGS under the Subpart H approval pathway, that the FDA will grant accelerated approval of sparsentan for FSGS or that sparsentan will be approved at all. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products. The Company faces additional risks associated with the potential impacts the COVID-19 pandemic may have on its business, including, but not limited to (i) the Company's ability to continue its ongoing development activities and clinical trials, (ii) the timing of such clinical trials and the release of data from those trials, (iii) the Company's and its suppliers' ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of its commercial products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

    Contact:

    Chris Cline, CFA

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879 

    IR@travere.com



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