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Business Wire
11-06-2025
- Business
- Business Wire
Travere Therapeutics to Present New FILSPARI® (sparsentan) Data at the 15 th International Podocyte Conference
SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present three abstracts on the effect of FILSPARI (sparsentan) in rare kidney disease at the upcoming International Podocyte Conference in Hamburg, Germany, June 10-13, 2025. The Company will present new data evaluating biomarkers of disease progression in IgA nephropathy (IgAN) from the Phase 2 SPARTAN Study showing rapid and sustained reductions in urinary BAFF and sC5b9 as well as reductions in proinflammatory and profibrotic biomarkers after starting FILSPARI, suggesting disease-modifying activity. 'At the International Podocyte conference, we're pleased to present new biomarker data from the SPARTAN Study that further support the kidney targeted benefit of FILSPARI in the clinical setting,' said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. 'Together with the broader body of existing nonclinical data on FILSPARI, these findings suggest the potential for disease-modifying effects in IgA nephropathy.' International Podocyte Conference Presentations Urinary Biomarker Analysis Reveals Rapid Intrarenal Anti-inflammatory and Antifibrotic Effects of Sparsentan in IgA nephropathy in the SPARTAN study Poster #: FR_11 Date: Friday, 13 June Location: Kleiner Festsaal Time: 10:30-11:15; 12:45-14:00 CEST Patients with Focal Segmental Glomerulosclerosis (FSGS) Achieved Low Proteinuria Targets Earlier and More Often with Sparsentan vs. Irbesartan in the DUPLEX Study Poster #: FR_26 Date: Friday, 13 June Location: Small banquet hall Time: 10:30-11:15; 12:45-14:00 CEST Sparsentan Has Direct Effects on the Glomerular Capillary Wall to Attenuate Increased Permeability in Nephrotic Syndrome Models 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 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 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 are currently no FDA-approved pharmacologic therapies for 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 and expectations regarding the kidney targeted benefit of FILSPARI in the clinical setting and the potential for disease-modifying effects in IgAN; 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.
Yahoo
10-06-2025
- Business
- Yahoo
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ('Inventiva' or the 'Company'), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ('MASH'), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company's Annual General Meeting. Mark Pruzanski, Chairman of Inventiva: 'We are thrilled to welcome Renée to the Board at this pivotal moment in Inventiva's journey. Her exceptional track record in our industry speaks for itself and will be key as we enter the final stages of clinical development for lanifibranor and prepare for its potential approval and launch.' Renée Aguiar-Lucander: 'I'm honored to have the opportunity to join Inventiva's Board. With the NATiV3 Phase 3 trial fully enrolled, I look forward to working with the team to potentially bring lanifibranor to patients with MASH.' Mrs. Aguiar-Lucander has served as the Chief Executive Officer of Hansa Biopharma since April 2025. She was previously Chief Executive Officer of Calliditas Therapeutics, where she led the transformation of the company from a small biotech company into a NASDAQ-listed, commercial-stage leader in rare diseases, culminating in its $1.1 billion acquisition by Asahi Kasei in 2024. Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy (TARPEYO®) and successfully launched the product in the U.S. Prior to her role at Calliditas, Ms. Aguiar-Lucander held various senior roles in the field of life sciences investment and corporate finance, including Partner and COO at Omega Fund Management and Managing Director at a global investment bank. She holds an MBA from INSEAD and a BA in Finance from the Stockholm School of Economics. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairsmedia@ +1 202 499 8937 Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Julia CailleteauMedia relations inventiva@ +33 1 53 96 83 83 ICR HealthcarePatricia L. BankInvestor relations +1 415 513 1284 Important Notice This press release contains certain 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, Inventiva's clinical trials, including Inventiva's ongoing NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including related timing and regulatory matters, Inventiva's pipeline development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'would', 'could', 'might', 'should', 'designed', 'hopefully', 'target', 'potential', 'possible', 'aim', and 'continue' and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing, to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to identify additional products or product candidates with significant commercial potential, Inventiva's expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva's ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil and natural catastrophes, uncertain financial markets and disruptions in banking systems, and the vote of Inventiva's shareholders. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the 'SEC') on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption 'Risk Factors' and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Appointment Renee Aguiar Lucanter to the Board - EN - 06 10 2025
Yahoo
10-06-2025
- Business
- Yahoo
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ('Inventiva' or the 'Company'), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ('MASH'), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company's Annual General Meeting. Mark Pruzanski, Chairman of Inventiva: 'We are thrilled to welcome Renée to the Board at this pivotal moment in Inventiva's journey. Her exceptional track record in our industry speaks for itself and will be key as we enter the final stages of clinical development for lanifibranor and prepare for its potential approval and launch.' Renée Aguiar-Lucander: 'I'm honored to have the opportunity to join Inventiva's Board. With the NATiV3 Phase 3 trial fully enrolled, I look forward to working with the team to potentially bring lanifibranor to patients with MASH.' Mrs. Aguiar-Lucander has served as the Chief Executive Officer of Hansa Biopharma since April 2025. She was previously Chief Executive Officer of Calliditas Therapeutics, where she led the transformation of the company from a small biotech company into a NASDAQ-listed, commercial-stage leader in rare diseases, culminating in its $1.1 billion acquisition by Asahi Kasei in 2024. Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy (TARPEYO®) and successfully launched the product in the U.S. Prior to her role at Calliditas, Ms. Aguiar-Lucander held various senior roles in the field of life sciences investment and corporate finance, including Partner and COO at Omega Fund Management and Managing Director at a global investment bank. She holds an MBA from INSEAD and a BA in Finance from the Stockholm School of Economics. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairsmedia@ +1 202 499 8937 Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Julia CailleteauMedia relations inventiva@ +33 1 53 96 83 83 ICR HealthcarePatricia L. BankInvestor relations +1 415 513 1284 Important Notice This press release contains certain 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, Inventiva's clinical trials, including Inventiva's ongoing NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including related timing and regulatory matters, Inventiva's pipeline development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'would', 'could', 'might', 'should', 'designed', 'hopefully', 'target', 'potential', 'possible', 'aim', and 'continue' and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing, to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to identify additional products or product candidates with significant commercial potential, Inventiva's expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva's ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil and natural catastrophes, uncertain financial markets and disruptions in banking systems, and the vote of Inventiva's shareholders. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the 'SEC') on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption 'Risk Factors' and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Appointment Renee Aguiar Lucanter to the Board - EN - 06 10 2025Sign in to access your portfolio
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10-06-2025
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IgA Nephropathy Market Analysis Report 2025-2035: Innovation in Renal Therapies and Accelerated Drug Approvals Drive Growth
The global IgA nephropathy market is in growth due to rising awareness, better diagnostics, and advanced treatments like complement inhibitors. North America leads the market, supported by regulatory advantages. Key players such as Novartis are driving innovation, though high costs and competition remain challenges. Dublin, June 10, 2025 (GLOBE NEWSWIRE) -- The "IgA Nephropathy Market - A Global and Regional Analysis: Focus on Regional Analysis - Analysis and Forecast, 2025-2035" report has been added to global IgA nephropathy market is currently in the growth stage of its lifecycle, driven by increasing awareness, improved diagnostic capabilities, and advancements in renal treatment options. The market is expanding as novel therapies, such as complement inhibitors and non-immunosuppressive drugs, are gaining traction, addressing the unmet need for more effective renal treatments. With ongoing research and development, pharmaceutical companies are investing heavily in clinical trials to bring new, targeted therapies to market. The global IgA nephropathy market is expected to grow at a significant rate due to advancements in diagnostic technologies, the development of innovative therapies, and increasing awareness among patients and healthcare regulatory bodies are accelerating the approval process for innovative renal drugs, further fueling market growth. Despite this positive momentum, challenges such as high treatment costs and the variability in disease progression may hinder rapid expansion. As a result, the market is expected to continue growing, although competition and price pressures will likely intensify as more treatments emerge. North America is expected to dominate the global IgA nephropathy market during the forecast period due to its advanced healthcare infrastructure, high prevalence, and increased awareness of the disease. The region also benefits from regulatory advantages and a strong pharmaceutical presence, which accelerates the availability of effective treatments and drives the growth of the global IgA nephropathy market. How Can This Report Add Value to an Organization?Product/Innovation Strategy: Product launches and innovations in the global IgA nephropathy market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease. Key players in the market, such as Novartis, and Travere Therapeutics, Inc., have been involved in the development of therapies for IgA Strategy: Enterprises led by market leaders in the global IgA nephropathy market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the Developments Regulatory Activities: In April 2025, the U.S. FDA granted accelerated approval for Novartis' Vanrafia (atrasentan) for the treatment of primary immunoglobulin A nephropathy. Partnerships: In March 2025, Folia Health and Novartis Pharmaceuticals, Inc. announced their collaboration on an innovative at-home observational real-world evidence initiative aimed at supporting individuals with IgA nephropathy. Regulatory Activities: In November 2024, South Korea approved Everest Medicines' NEFECON for the treatment of primary IgA nephropathy. Regulatory Activities: In September 2024, Ligand partner Travere Therapeutics received FDA approval for FILSPARI (sparsentan), the only non-immunosuppressive treatment that significantly slows kidney function decline in IgA nephropathy. Market Dynamics Drivers: Increasing Prevalence of IgA Nephropathy Continuous Advancements in Treatment Options Improved Diagnosis and Awareness Challenges: High Treatment Costs Limited Awareness in Developing Markets Key Market Players and Competition Synopsis Novartis F. Hoffmann-La Roche Ionis Pharmaceuticals Vertex Pharmaceuticals Otsuka Pharmaceutical Biogen Arrowhead Pharmaceuticals NovelMed Q32 Bio Walden Biosciences Takeda Pharmaceutical Vera Therapeutics Biocity Biopharmaceutics Co., Ltd. Calliditas Therapeutics AB Travere Therapeutics, Inc. Alexion Pharmaceuticals, Inc. Key Topics Covered: Executive SummaryScope and Definition1. Global IgA Nephropathy Market: Market Outlook1.1 Industry Outlook1.1.1 Market Overview and Ecosystem1.1.2 Market Trends1.1.3 Epidemiological Analysis of IgA Nephropathy1.1.3.1 By Region1.1.3.1.1 U.S.1.1.3.1.2 EU51.1.3.1.3 Rest-of-the-World1.1.4 Clinical Trials1.1.4.1 By Phase1.1.4.2 By Sponsor Type1.1.5 Regulatory Landscape / Compliance1.1.5.1 Legal Requirement and Framework in the U.S.1.1.5.2 Legal Requirement and Framework in the E.U.1.1.5.3 Legal Requirement and Framework in Asia-Pacific1.1.5.4 Legal Requirement and Framework in Rest-of-the-World1.2 Market Dynamics1.2.1 Impact Analysis1.2.2 Market Drivers1.2.3 Market Restraints1.2.4 Market Opportunities2. Global IgA Nephropathy Market (By Region), $Million, 2023-20352.1 North America2.1.1 Key Findings2.1.2 Market Dynamics2.1.3 Market Sizing and Forecast2.1.3.1 North America IgA Nephropathy Market (by Country)2.1.3.1.1 U.S.2.1.3.1.2 Canada2.2 Europe2.2.1 Key Findings2.2.2 Market Dynamics2.2.3 Market Sizing and Forecast2.2.3.1 Europe IgA Nephropathy Market (by Country)2.2.3.1.1 U.K.2.2.3.1.2 Germany2.2.3.1.3 France2.2.3.1.4 Italy2.2.3.1.5 Spain2.2.3.1.6 Rest-of-Europe2.3 Asia-Pacific2.3.1 Key Findings2.3.2 Market Dynamics2.3.3 Market Sizing and Forecast2.3.3.1 Asia-Pacific IgA Nephropathy Market (by Country)2.3.3.1.1 Japan2.3.3.1.2 China2.3.3.1.3 Rest-of-Asia-Pacific2.4 Rest-of-the-World2.4.1 Key Findings2.4.2 Market Dynamics2.4.3 Market Sizing and Forecast3. Global IgA Nephropathy Market - Competitive Benchmarking and Company Profiles3.1 Competitive Landscape3.1.1 Key Strategies and Developments by Company3.1.1.1 Funding Activities3.1.1.2 Mergers and Acquisitions3.1.1.3 Regulatory Approvals3.1.1.4 Partnerships, Collaborations and Business Expansions3.1.2 Key Developments Analysis3.2 Company Profiles3.2.1 Company Overview3.2.2 Product Portfolio3.2.3 Target Customers/End Users3.2.4 Analyst View4. Research MethodologyFor more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error 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
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09-06-2025
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Calliditas Therapeutics Presented at the 62nd European Renal Association Congress
STOCKHOLM, June 9, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that new data was presented at the 62nd European Renal Association Congress (ERA Congress), which took place in Vienna, Austria, from June 4 to 7. The presentations included secondary analyses and new insights from biomarker from the Phase 3 NefIgArd study of Nefecon (marketed as TARPEYO® [budesonide] delayed-release capsules in the United States in patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression and Kinpeygo® in Europe for the treatment of adults with primary immunoglobulin A nepropathy (IgAN) with a urine protein excretion ≥ 1.0g/day (or urine protein-to-creatinine ration ≥ 0.8g/g) and in the United Kingdom for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram). A total of five abstracts were accepted for presentation, including one selected as a Top 10 abstract for oral presentation, along with four additional focused oral presentations. Oral Presentation Details Abstract No. 3345 – Selected as a Top 10 AbstractTitle: "Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Jonathan Barratt, United Kingdom Focused Oral Presentation Details Abstract No. 3251Title: "Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: A subanalysis of the NefIgArd study"Presenter: Richard Lafayette, United States Abstract No. 3337Title: "The NefXtend trial, investigating extended Nefecon treatment beyond 9 months in patients with IgAN"Presenter: Richard Lafayette, United States Abstract No. 2642Title: "Effects of Nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: A full NefIgArd analysis"Presenter: Ishika Khan, United Kingdom Abstract No. 2651Title: "Sustainability and depth of UPCR reduction in patients with primary IgAN treated with Nefecon: A secondary analysis of the Phase 3 NefIgArd trial"Presenter: Jonathan Barratt, United Kingdom The ERA Congress is a leading international event focused on kidney health and renal science. Organized by the European Renal Association, the 2025 Congress brought together nephrologists, researchers, and healthcare professionals from across the globe for scientific sessions, interactive workshops, and networking opportunities. The event aimed to advance research, clinical care, and innovation in nephrology. About TARPEYO®/Kinpeygo®TARPEYO® is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1), causing IgA nephropathy. About Primary Immunoglobulin A NephropathyPrimary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s. About CalliditasCalliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit for further information. About Asahi KaseiThe Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Healthcare. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit View original content to download multimedia: SOURCE Asahi Kasei Corporation 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
