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Travere Therapeutics to Present New FILSPARI® (sparsentan) Data at the 62nd ERA Congress
Travere Therapeutics to Present New FILSPARI® (sparsentan) Data at the 62nd ERA Congress

Yahoo

time6 days ago

  • Business
  • Yahoo

Travere Therapeutics to Present New FILSPARI® (sparsentan) Data at the 62nd ERA Congress

Data from SPARTACUS and PROTECT OLE to show significant proteinuria reduction when replacing RASi with FILSPARI and when FILSPARI is used in combination with SGLT2i New mechanistic data to show FILSPARI protects against IgA deposition in the kidney SAN DIEGO, June 03, 2025--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present seven abstracts at the upcoming European Renal Association (ERA) Congress in Vienna, Austria, June 4-7. Presentations will include new data on the use of FILSPARI in IgA nephropathy (IgAN) from the Phase 2 SPARTACUS Study which demonstrated that FILSPARI provided clinically meaningful benefits in adults with IgAN who replaced their renin-angiotensin system inhibitor (RASi) with FILSPARI while receiving stable sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy. A presentation on results from the open label extension (OLE) of the Phase 3 PROTECT Study will show that patients previously treated with maximum labeled irbesartan experienced significant proteinuria reduction after switching to FILSPARI in the study. In a preclinical model of IgAN, FILSPARI protected from mesangial deposition of IgA, suggesting a potential role of endothelin-1 and angiotensin II as modulators of disease activity in IgAN. Data from the gddY mouse model of IgAN will offer new insight into the pathogenesis of IgAN as a tissue-specific autoimmune disease. In focal segmental glomerulosclerosis (FSGS), the Company will share a data analysis from the Phase 3 DUPLEX Study showing that partial and complete proteinuria remission were achieved earlier and more frequently with FILSPARI than irbesartan. The Company will also present preclinical data in an animal model of immune-mediated FSGS showing that optimized dual endothelin and angiotensin blockade with FILSPARI helps protect the integrity of the glomerular filtration barrier, reducing glomerular permeability and lowering albuminuria. "The breadth of data we're presenting underscores our confidence in the role FILSPARI can serve as foundational therapy for rare kidney diseases," said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. "These findings provide further evidence that FILSPARI can decrease the risk of IgAN disease progression. We are deeply committed to advancing research and delivering innovative therapies that can make a meaningful difference for people living with IgAN and FSGS." European Renal Association Congress Presentations Sparsentan Added to Stable Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2is) in Adults with IgA Nephropathy (IgAN) in the Phase 2 SPARTACUS Trial Abstract: No. 1916Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 9:00-9:05 CESTLocation: Focused Oral Room 3 Effects of Sparsentan After Maximized Angiotensin Receptor Blocker (ARB) Treatment in Patients with IgA Nephropathy (IgAN) in the PROTECT Trial Abstract: No. 1920Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 9:05-9:10 CESTLocation: Focused Oral Room 3 Patients with Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often with Sparsentan (SPAR) vs. Irbesartan (IRB) in DUPLEX Abstract: No. 2444Session: Glomerular & Tubulointerstitial DiseasesDate: June 6, 2025, 16:40-16:45 CESTLocation: Focused Oral Room 2 Kidney Outcomes and Effects of Proteinuria in Alport Syndrome: a Longitudinal Analysis of Using Data from the National Registry of Rare Kidney Diseases (RaDaR) Abstract: No. 2883Session: FC 12: Membranous Nephropathy and Other Rare DiseasesDate: June 5, 2025, 18:12-18:24 CESTLocation: Hall K Population Modeling Depicts the Mutational Burden of NPHS2 (Podocin) Nephropathy and Reveals an Undiagnosed Adult-Onset Genetic Cohort Abstract: No. 1346Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 15:00-15:06 CESTLocation: XWall I Mozart Eine Kleine Nachtmusik Sparsentan Reversibly Decreases Mesangial IgA Deposition in gddY Mice; A Possible Role for Mesangial-Cell-Surface Autoantigen Expression Abstract: No. 733Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 8:33-8:39 CESTLocation: Focused Oral Room 2 Sparsentan Reduces Glomerular Dysfunction and Proteinuria in a Rat Model of Serum-Factor-Induced Nephrotic Syndrome Abstract: No. 272Session: Glomerular & Tubulointerstitial DiseasesDate: June 5, 2025, 9:48-9:51 CESTLocation: Hall K About IgA Nephropathy IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the U.S. and is one of the most common glomerular diseases in Europe and Japan. About Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. Sparsentan is not approved for use in FSGS. There is currently no approved pharmacologic indicated for the treatment of FSGS. 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 FILSPARI® (sparsentan) U.S. Indication FILSPARI (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risks of hepatotoxicity and birth defects, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI can cause major birth defects if used by pregnant patients based on animal data. Therefore, pregnancy testing is required before the initiation of treatment, during treatment and one month after discontinuation of treatment with FILSPARI. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and monthly for the first 12 months, then every 3 months during treatment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended. Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) prior to drug initiation because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity: FILSPARI can cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. Advise patients who can become pregnant of the potential risk to a fetus. Obtain a pregnancy test prior to initiation of treatment with FILSPARI, monthly during treatment, and one month after discontinuation of treatment. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements ( Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs, and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Most common adverse reactions The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Drug interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid reducing agents may decrease sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates, which may increase the risk of adverse reactions related to these substrates. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. 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 "on-track," "positioned," "look forward to," "will," "would," "may," "might," "believes," "anticipates," "plans," "expects," "intends," "potential," or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements relating to the clinical studies and models described herein, and data to be presented; statements regarding the potential role of FILSPARI as foundational therapy for rare kidney diseases; statements regarding the impact of FILSPARI on IgAN disease progression; statements regarding the goal of advancing research and delivering innovative therapies that can make a meaningful difference for people living with IgAN and FSGS; and statements related to the estimated sizes of patient populations. 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 related to the Company's sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the ongoing commercial launch of FILSPARI in IgAN, the timing and potential outcome of its and its partners' clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the 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, including as a result of macroeconomic conditions; risks 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 also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. 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, including under the heading "Risk Factors", as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission. View source version on Contacts Media:888-969-7879mediarelations@ Investors:888-969-7879IR@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals
Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals

Globe and Mail

time13-05-2025

  • Health
  • Globe and Mail

Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals

The Key IgA Nephropathy Companies in the market include - Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others. DelveInsight's 'IgA Nephropathy Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the IgA Nephropathy, historical and forecasted epidemiology as well as the IgA Nephropathy market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. Some of the key facts of the IgA Nephropathy Market Report: The IgA Nephropathy market size was valued approximately USD 730 million in 2024 and is anticipated to grow with a significant CAGR during the study period (2020-2034) In March 2025, Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced topline findings from Part 2 of its Phase 1/2 clinical trial evaluating ARO-C3, an investigational RNA interference (RNAi) therapy aimed at lowering liver production of complement component 3 (C3) to potentially treat multiple complement-mediated disorders. In November 2024, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical Co., Ltd. have announced plans to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational therapy for adult patients with immunoglobulin A nephropathy (IgA nephropathy), in the first half of 2025. This decision follows a recent meeting with the U.S. FDA to review the positive interim findings from the Phase 3 VISIONARY trial (NCT05248646). In January 2024, Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company in the advanced stages of clinical development focused on innovative treatments for individuals with severe immunologic conditions, announced today the addition of two seasoned industry professionals to spearhead the advancement of the company's drug initiatives. This includes their late-stage candidate, atacicept, presently undergoing a Phase 3 clinical trial for IgA nephropathy (IgAN). Effective immediately, Robert M. Brenner, M.D., assumes the role of Chief Medical Officer, succeeding Dr. Celia Lin, M.D., while William D. Turner takes on the position of Chief Development Officer. In 2024, the market size for IgA Nephropathy (IgAN) in the US was around USD 455 million and is expected to grow with the introduction of emerging therapies. The total market size for the EU4 and the UK was estimated at around USD 150 million in 2024, representing nearly 21% of the overall market revenue for the 7MM, with growth expected by 2034. In 2024, Germany led the IgAN market among the EU4 and the UK with approximately USD 45 million in revenue, followed by France at around USD 35 million and Italy at nearly USD 30 million. In 2024, Japan's IgAN market size was estimated at around USD 125 million, with expectations of growth throughout the forecast period from 2025 to 2034. DelveInsight estimates that around 415,000 prevalent cases of IgA Nephropathy (IgAN) were reported across the 7MM in 2024. These diagnosed cases are expected to grow at a CAGR of 0.6% by 2034. In 2024, the United States reported approximately 133,000 diagnosed prevalent cases of IgA Nephropathy (IgAN), with numbers expected to rise by 2034. In 2024, Germany had the highest number of diagnosed prevalent cases of IgA Nephropathy (IgAN) among the EU4 and the UK, with approximately 30,000 cases, while Spain had the lowest, with around 5,000 cases. In 2024, Japan reported the highest number of diagnosed prevalent cases of IgA Nephropathy (IgAN) among the 7MM, with nearly 175,000 cases, and this number is projected to increase by 2034. In 2024, France reported around 16,000 diagnosed prevalent cases of IgA Nephropathy (IgAN) in males and 8,000 in females, with both numbers anticipated to increase by 2034. Key IgA Nephropathy Companies: Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others Key IgA Nephropathy Therapies: VANRAFIA (atrasentan), FILSPARI (sparsentan), TARPEYO/KINPEYGO (budesonide), Povetacicept (ALPN-303), Atacicept, Zigakibart (FUB523), Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others The IgA Nephropathy epidemiology based on gender analyzed that IgAN is more prominent in males in comparison to females. Prevalence of IgAN occurs in men around two times more than females worldwide. The IgA Nephropathy market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage IgA Nephropathy pipeline products will significantly revolutionize the IgA Nephropathy market dynamics. IgA Nephropathy Overview IgA nephropathy, also known as Berger's disease, is a kidney disorder characterized by the buildup of the antibody immunoglobulin A (IgA) in the kidneys. This buildup can lead to inflammation and damage to the tiny filters in the kidneys called glomeruli. IgA nephropathy is one of the most common forms of glomerulonephritis, which is inflammation of the glomeruli. IgA Nephropathy Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. IgA Nephropathy Epidemiology Segmentation: The IgA Nephropathy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalence of IgA Nephropathy Prevalent Cases of IgA Nephropathy by severity Gender-specific Prevalence of IgA Nephropathy Diagnosed Cases of Episodic and Chronic IgA Nephropathy Download the report to understand which factors are driving IgA Nephropathy epidemiology trends @ IgA Nephropathy Epidemiology Forecast IgA Nephropathy Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the IgA Nephropathy market or expected to get launched during the study period. The analysis covers IgA Nephropathy market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the IgA Nephropathy Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. IgA Nephropathy Therapies and Key Companies VANRAFIA (atrasentan): Novartis FILSPARI (sparsentan): Travere Therapeutics TARPEYO/KINPEYGO (budesonide): Asahi Kasei (Calliditas Therapeutics) Povetacicept (ALPN-303): Vertex Pharmaceuticals Atacicept: Vera Therapeutics Zigakibart (FUB523): Novartis Sibeprenlimab: Visterra Atrasentan: Chinook Therapeutics LNP023: Novartis Pharmaceuticals Research programme: IgA proteases Selecta Biosciences AP 305: Shanghai Alebund Pharmaceuticals ADR-001: Rohto Pharmaceutical MY 008: Wuhan Createrna Science and Technology SHR-2010: Guangdong Hengrui Pharmaceutical IONIS FB: LRx Ionis Pharmaceuticals HR19042: Jiangsu HengRui Medicine Co., Ltd. Sparsentan: Travere Therapeutics HR19042: Jiangsu HengRui Medicine Co., Ltd. Discover more about therapies set to grab major IgA Nephropathy market share @ IgA Nephropathy Treatment Landscape IgA Nephropathy Market Drivers Increase in prevalence of IgA Nephropathy (IgAN), increment in the number of government initiatives to spread awareness are some of the important factors that are fueling the IgA Nephropathy Market. IgA Nephropathy Market Barriers However, lack of in-depth understanding of the disease pathogenesis, the unreported and undiagnosed IgA Nephropathy cases and other factors are creating obstacles in the IgA Nephropathy Market growth. Scope of the IgA Nephropathy Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key IgA Nephropathy Companies: Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others Key IgA Nephropathy Therapies: VANRAFIA (atrasentan), FILSPARI (sparsentan), TARPEYO/KINPEYGO (budesonide), Povetacicept (ALPN-303), Atacicept, Zigakibart (FUB523), Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others IgA Nephropathy Therapeutic Assessment: IgA Nephropathy current marketed and IgA Nephropathy emerging therapies IgA Nephropathy Market Dynamics: IgA Nephropathy market drivers and IgA Nephropathy market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies IgA Nephropathy Unmet Needs, KOL's views, Analyst's views, IgA Nephropathy Market Access and Reimbursement Table of Contents 1. IgA Nephropathy Market Report Introduction 2. Executive Summary for IgA Nephropathy 3. SWOT analysis of IgA Nephropathy 4. IgA Nephropathy Patient Share (%) Overview at a Glance 5. IgA Nephropathy Market Overview at a Glance 6. IgA Nephropathy Disease Background and Overview 7. IgA Nephropathy Epidemiology and Patient Population 8. Country-Specific Patient Population of IgA Nephropathy 9. IgA Nephropathy Current Treatment and Medical Practices 10. IgA Nephropathy Unmet Needs 11. IgA Nephropathy Emerging Therapies 12. IgA Nephropathy Market Outlook 13. Country-Wise IgA Nephropathy Market Analysis (2020–2034) 14. IgA Nephropathy Market Access and Reimbursement of Therapies 15. IgA Nephropathy Market Drivers 16. IgA Nephropathy Market Barriers 17. IgA Nephropathy Appendix 18. IgA Nephropathy Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:

Travere Therapeutics to Participate at Upcoming Investor Conferences
Travere Therapeutics to Participate at Upcoming Investor Conferences

Business Wire

time07-05-2025

  • Business
  • Business Wire

Travere Therapeutics to Participate at Upcoming Investor Conferences

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that company management will participate in the following upcoming investor conferences: Travere Therapeutics to Participate at Upcoming Investor Conferences Share BofA Securities 2025 Healthcare Conference Presenting on Wednesday, May 14, 2025, at 3:40 p.m. PT Jefferies Global Healthcare Conference Presenting on Wednesday, June 4, 2025, at 3:10 p.m. ET Scotiabank Third Annual Healthcare Canadian Investor Day Tuesday, June 17, 2025 Live webcasts of the BofA Securities 2025 Healthcare Conference and Jefferies Global Healthcare Conference presentations will be accessible on the Investor page of Travere's website at Replays will be available for up to 30 days following each event. 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 Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI
Travere Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI

Business Wire

time29-04-2025

  • Business
  • Business Wire

Travere Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI

SAN DIEGO & ST. GALLEN, Switzerland--(BUSINESS WIRE)--Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. 'The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe,' said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. 'This decision not only validates the strength of the Phase 3 PROTECT Study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN.' 'The decision by the European Commission is an important advancement for people living with IgAN in the EU,' said Vinicius Gomes De Lima, M.D., head of global medical affairs at CSL Vifor. 'The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe.' The European Commission's decision follows the Committee for Medicinal Products for Human Use (CHMP) recommendation from February 2025 to convert the CMA to standard MA. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal Phase 3 PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. As a result of the standard approval, the Company expects to receive a $17.5 million milestone payment from CSL Vifor, and the Company remains eligible to receive additional milestone payments related to market access and sales-based achievements for FILSPARI. FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in Europe and is currently available in Germany, Austria and Switzerland. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) converted the conditional FILSPARI approval to standard approval as of April 15, 2025. FILSPARI is indicated for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥ 0.75 g/g); the indication is unchanged in the UK. 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 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, About IgA Nephropathy (IgAN) IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (Europe, Australia and New Zealand). About the PROTECT Study The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head vs. comparator trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. eGFR is a blood test that measure how well kidneys filter waste products from blood. Treatment emergent adverse events were well-balanced between sparsentan and irbesartan, except for dizziness and hypotension. About FILSPARI (sparsentan) FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. FILSPARI is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. For more information, please refer to the Summary of Product Characteristics (SmPC). FILSPARI ® (sparsentan) U.S. Indication FILSPARI (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risks of hepatotoxicity and birth defects, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI can cause major birth defects if used by pregnant patients based on animal data. Therefore, pregnancy testing is required before the initiation of treatment, during treatment and one month after discontinuation of treatment with FILSPARI. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and monthly for the first 12 months, then every 3 months during treatment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended. Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) prior to drug initiation because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity: FILSPARI can cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. Advise patients who can become pregnant of the potential risk to a fetus. Obtain a pregnancy test prior to initiation of treatment with FILSPARI, monthly during treatment, and one month after discontinuation of treatment. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with FILSPARI. FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements ( Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs, and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Most common adverse reactions The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Drug interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid reducing agents may decrease sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates, which may increase the risk of adverse reactions related to these substrates. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. 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 'on-track,' 'positioned,' 'look forward to,' 'will,' 'would,' 'may,' 'might,' 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'potential,' or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: statements and expectations regarding the expansion of access to FILSPARI in Europe and improvement in outcomes for those affected by IgAN; statements regarding future milestone payments; and statements related to the estimated size of patient populations. 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, as well as risks and uncertainties associated with the continued commercial launch of FILSPARI in IgAN. The Company also faces risks and uncertainties related to its sNDA for FILSPARI in FSGS, including the timing and outcome thereof. There is no guarantee that the FDA will accept the sNDA for filing, grant priority review of the sNDA or grant approval of FILSPARI for FSGS on the anticipated timeline, or at all. The Company also faces risks and uncertainties related to its business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the timing and potential outcome of its and its partners' clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the new administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the 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, including as a result of macroeconomic conditions; risks 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 also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. 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, including under the heading 'Risk Factors', as included in the Company's most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

Travere Therapeutics to Report First Quarter 2025 Financial Results
Travere Therapeutics to Report First Quarter 2025 Financial Results

Business Wire

time24-04-2025

  • Business
  • Business Wire

Travere Therapeutics to Report First Quarter 2025 Financial Results

SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced it will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of the U.S. financial markets. The Company will host a conference call and webcast to discuss the financial results and provide a general business update at 4:30 p.m. ET. Travere Therapeutics will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of the U.S. financial markets. Share The webcast and dial-in information can be accessed on the Investor page of Travere's website at Following the live webcast, an archived version of the call will be available for 30 days on the Company's website. 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

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