logo
#

Latest news with #Calliditas

Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors

Yahoo

time3 days ago

  • 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

Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors

Yahoo

time3 days ago

  • 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

Calliditas Therapeutics Presented at the 62nd European Renal Association Congress
Calliditas Therapeutics Presented at the 62nd European Renal Association Congress

Yahoo

time4 days ago

  • Health
  • Yahoo

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

Emerging Treatments Drive Notable Changes in IgA Nephropathy Care Across Key Global Markets, According to Spherix Global Insights
Emerging Treatments Drive Notable Changes in IgA Nephropathy Care Across Key Global Markets, According to Spherix Global Insights

Yahoo

time08-05-2025

  • Health
  • Yahoo

Emerging Treatments Drive Notable Changes in IgA Nephropathy Care Across Key Global Markets, According to Spherix Global Insights

Products such as Tarpeyo (Calliditas), Filspari (Travere) and now Novartis' Fabhalta and Venrafia provide physicians more options than ever before. EXTON, PA, May 08, 2025 (GLOBE NEWSWIRE) -- With multiple targeted therapies now available and SGLT2 inhibitors broadly embraced, nephrologists across the globe are redefining how they manage IgA Nephropathy (IgAN) patients. Data from Spherix Global Insights' comprehensive Patient Chart Dynamix™ services—spanning over 2,300 patient charts across the US, EU5, Japan, and China—demonstrate the magnitude of this shift, highlighting differences in treatment patterns, product adoption, and future intent across markets. As standard treatment practice increasingly incorporates SGLT2 inhibitors—initially reserved for diabetes and then diabetic kidney disease—nephrologists are initiating these agents earlier in the treatment algorithm, citing emerging data supporting their protective effects in CKD, including IgAN. Adoption has grown substantially year-over-year in all surveyed markets. While regional differences exist, the early use of SGLT2 inhibitors, in combination with RAASi, is now widely accepted as foundational care for non-dialysis IgAN patients. Overlaying this supportive care are newly launched agents designed specifically for IgAN. Calliditas' Tarpeyo® (budesonide) and Travere's Filspari® (sparsentan) have quickly gained traction in the US, with prescribing steadily moving upstream in the treatment paradigm. Indeed, nearly one in five US IgAN patients are currently managed with Tarpeyo, and Filspari's use has nearly doubled in the past year alone. Across Europe, Kinpeygo—Tarpeyo's EU label—has seen notable growth, especially in Germany and the UK. Filspari's limited availability at the time of fielding across many regions somewhat constrained its uptake, though future use intentions are high as access expands. In China, Nefecon (budesonide) has rapidly secured a foothold, with many patients already initiated on therapy. Despite different access landscapes, nephrologists are aligned on one key goal: reducing proteinuria to below 0.5g/day. Yet, many patients remain above this threshold despite therapy, underscoring the need for additional, more effective options. Enter Novartis, with Fabhalta® (iptacopan), recently approved in the US and garnering early interest for use in later lines of therapy. Vanrafia®, also from Novartis, has just received its first approval and is poised to further expand the treatment armamentarium. Together, these products—alongside pipeline agents targeting the complement system, APRIL/BAFF pathways, and other novel MOAs—represent a new chapter in IgAN care focused on underlying disease pathophysiology. Importantly, Spherix's data highlight regional nuances in how nephrologists view and sequence these therapies. In Japan, tonsillectomy remains a widely accepted option and is often paired with systemic corticosteroids. In contrast, physicians in the US and China are increasingly moving away from broad immunosuppression in favor of targeted mechanisms with improved safety profiles. While there is general agreement on first-line strategies, subsequent lines of therapy are in flux, shaped by clinical experience, product availability, and evolving guideline recommendations. Physicians continue to prioritize clinical data demonstrating both proteinuria reduction and eGFR preservation when evaluating new options, though safety warnings remain a barrier to adoption for some. Even so, enthusiasm for therapies with novel mechanisms continues to grow, particularly in markets where patients remain difficult to manage despite standard therapies. With over five years of continuous tracking, Spherix Global Insights has established the most robust and consistent global dataset on IgAN, offering the industry's most comprehensive view of how real-world treatment decisions have evolved and how emerging therapies are being integrated into clinical practice. By continuing to track real-world patient management trends and comparing data across markets, Spherix delivers actionable insights that support strategic decision-making for stakeholders across the nephrology landscape. Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the 'why' behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: Spherix Global Insights Contacts Tucker Hurtado, Nephrology Franchise Head NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Tucker Hurtado, Nephrology Franchise Head Spherix Global Insights 4848794284 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

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store