{"success":true,"data":{"pressRelease":{"id":"178867","rtpr_id":"nBw5TMr18a-20261023","ticker":"TVTX","exchange":"NASDAQ","all_tickers":["TVTX"],"title":"Travere Presents New Biomarker Data at ASN Kidney Week Suggesting FILSPARI® (sparsentan) May Modify Underlying Disease Pathophysiology in IgA Nephropathy","author":"Business Wire","published_at":"2026-10-23T23:20:00.095Z","article_body":"Travere Presents New Biomarker Data at ASN Kidney Week Suggesting FILSPARI(®)\n(sparsentan) May Modify Underlying Disease Pathophysiology in IgA Nephropathy\n\nFILSPARI achieved greater reductions in biomarkers linked to kidney\ninflammation and injury than maximum labeled dose irbesartan\n\nFindings provide further evidence of the biological effects of dual endothelin\nand angiotensin receptor antagonism and support FILSPARI as foundational\ntreatment in IgAN \n\nTravere Therapeutics, Inc. (Nasdaq: TVTX) today presented new biomarker data\nfrom the Phase 3 PROTECT Study providing evidence that FILSPARI® (sparsentan)\nmay modify the underlying disease pathophysiology in people with IgA\nnephropathy (IgAN). Data were shared today in an oral presentation at the\nAmerican Society of Nephrology (ASN) Kidney Week 2026 in Denver, CO.\n\n“These biomarker data provide new insight into how FILSPARI’s dual\nmechanism of action may modify the underlying biology of IgA nephropathy,”\nsaid Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “When\nconsidered alongside the PROTECT results which demonstrated superior\nproteinuria reduction and a slower rate of kidney function decline compared\nwith maximum labeled dose irbesartan, as well as published real-world evidence\nshowing consistent outcomes in clinical practice, the totality of evidence\nsupports the use of FILSPARI as a non-immunosuppressive, kidney-targeted,\nfoundational first-line treatment for IgA nephropathy.”\n\nThe Phase 3 PROTECT Study was a global, randomized, multicenter, double-blind,\nactive-controlled clinical trial evaluating the safety and efficacy of\nFILSPARI, compared to irbesartan in 404 adult patients with IgAN. Of the\noverall study population, 295 patients participated in the biomarker analysis.\nAcross measured time points through Week 110, FILSPARI led to rapid and\nsustained reductions in all four urinary biomarkers evaluated.\n\n“These findings extend the exploratory signal observed in SPARTAN and show\nin a larger, randomized study that dual endothelin and angiotensin receptor\nantagonism may modulate several biological pathways associated with IgAN\npathophysiology,” said Chee Kay Cheung, M.B.Ch.B., Ph.D., consultant\nnephrologist at University Hospitals of Leicester NHS Trust.\n\nAt Week 110, least-squares mean percent changes from baseline, normalized to\nurine creatinine, were greater with FILSPARI than with irbesartan (reported p\nvalues are nominal):\n\n * sCD163, a marker of macrophage activation, decreased 60.1% with FILSPARI\nversus 26.0% with irbesartan, representing a 46.1% difference between\ntreatment arms (p<0.001).\n * BAFF, a marker of B-cell activation and survival, decreased 64.4% with\nFILSPARI versus 45.2% with irbesartan, representing a 34.9% difference between\ntreatment arms (p=0.02).\n * C5b-9, a marker of complement pathway activation, decreased 50.2% with\nFILSPARI versus 7.3% with irbesartan, representing a 46.3% difference between\ntreatment arms (p=0.032).\n * IL-6, a pro-inflammatory cytokine, decreased 45.4% with FILSPARI versus an\n8.7% increase with irbesartan, representing a 49.7% difference between\ntreatment arms (p<0.001).\nThe findings build on previously reported PROTECT results which demonstrated\nsuperior proteinuria reduction and a slower rate of kidney function decline\nwith FILSPARI compared with maximum labeled dose irbesartan. The consistency\nof effects across clinical outcomes and multiple biomarkers associated with\nIgAN disease biology provides further evidence that FILSPARI’s dual\nendothelin and angiotensin receptor antagonism may provide benefits beyond\nconventional RAS inhibition and supports its differentiated profile as an\nearly, foundational, non-immunosuppressive treatment for IgAN.\n\nMore information on Travere’s presence at ASN Kidney Week can be found here\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fmedicalaffairs.travere.com%2Fmeetings-events%2Fasn-kidney-week-2026%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=here&index=1&md5=d5104b6befd3370ba2cbaf645f9a7b23)\n.\n\nAbout the PROTECT Study\n\nThe Phase 3 PROTECT Study was a global, randomized, multicenter, double-blind,\nactive-controlled clinical trial evaluating the efficacy and safety of\nFILSPARI compared with maximum labeled dose irbesartan in 404 adults with\nbiopsy-confirmed IgAN. Participants had urine protein excretion (UPE) ≥1.0\ng/d and an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73\nm² despite optimized renin-angiotensin system inhibitor therapy. Participants\nwere randomized 1:1 to receive FILSPARI 400 mg/day or irbesartan 300 mg/day\nfor up to 110 weeks. The primary efficacy endpoint was the change in\nproteinuria from baseline at Week 36, and the key secondary efficacy endpoint\nwas the rate of change in eGFR through Week 110.\n\nAbout Travere Therapeutics\n\nAt Travere Therapeutics, we are in rare for life. We are a biopharmaceutical\ncompany that comes together every day to help patients, families and\ncaregivers of all backgrounds as they navigate life with a rare disease. On\nthis path, we know the need for treatment options is urgent – that is why\nour global team works with the rare disease community to identify, develop and\ndeliver life-changing therapies. In pursuit of this mission, we continuously\nseek to understand the diverse perspectives of rare patients and to\ncourageously forge new paths to make a difference in their lives and provide\nhope – today and tomorrow. For more information, visit travere.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=travere.com&index=2&md5=e10efee62a519272802e63557083b353)\n.\n\nFILSPARI(®) (sparsentan) U.S. Indication\n\nFILSPARI(®) (sparsentan) is indicated:\n\n * To slow kidney function decline in adults with primary immunoglobulin A\nnephropathy (IgAN) who are at risk for disease progression.\n * To reduce proteinuria in adult and pediatric patients aged 8 years and older\nwith focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY\n\nBecause of the risk of hepatotoxicity, FILSPARI is available only through a\nrestricted program called the FILSPARI REMS. Under the FILSPARI REMS,\nprescribers, patients and pharmacies must enroll in the program.\n\nHepatotoxicity\n\nSome Endothelin Receptor Antagonists (ERAs) have caused elevations of\naminotransferases, hepatotoxicity, and liver failure. In clinical studies,\nelevations in aminotransferases (ALT or AST) of at least 3-times the Upper\nLimit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated\npatients, including cases confirmed with rechallenge.\n\nMeasure transaminases and bilirubin before initiating treatment and then every\n3 months during treatment. Interrupt treatment and closely monitor patients\nwho develop aminotransferase elevations more than 3x ULN.\n\nFILSPARI should generally be avoided in patients with elevated\naminotransferases (>3x ULN) at baseline because monitoring for\nhepatotoxicity may be more difficult and these patients may be at increased\nrisk for serious hepatotoxicity.\n\nEmbryo-Fetal Toxicity\n\nFILSPARI is contraindicated for use during pregnancy because it may cause\nfetal harm if used by pregnant patients. Therefore, in patients who can become\npregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of\neffective contraception before the initiation of treatment, during treatment,\nand for two weeks after discontinuation of treatment with FILSPARI. When\npregnancy is detected, discontinue FILSPARI as soon as possible.\n\nContraindications\n\nFILSPARI is contraindicated in patients who are pregnant. Do not coadminister\nFILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.\n\nWarnings and Precautions\n\n * Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been\nobserved in up to 3.5% of FILSPARI-treated patients, including cases confirmed\nwith rechallenge. While no concurrent elevations in bilirubin >2-times ULN\nor cases of liver failure were observed in FILSPARI-treated patients in\nclinical trials, some ERAs have caused elevations of aminotransferases,\nhepatotoxicity, and liver failure. To reduce the risk of potential serious\nhepatotoxicity, measure serum aminotransferase levels and total bilirubin\nprior to initiation of treatment and then every 3 months during treatment.\n\nAdvise patients with symptoms suggesting hepatotoxicity (nausea, vomiting,\nright upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or\nitching) to immediately stop treatment with FILSPARI and seek medical\nattention. If aminotransferase levels are abnormal at any time during\ntreatment, interrupt FILSPARI and monitor as recommended.\n\nConsider re-initiation of FILSPARI only when hepatic enzyme levels and\nbilirubin return to pretreatment values and only in patients who have not\nexperienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI\nin patients with elevated aminotransferases (>3x ULN) because monitoring\nhepatotoxicity in these patients may be more difficult and these patients may\nbe at increased risk for serious hepatotoxicity.\n * FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only\nthrough a restricted program called the FILSPARI REMS. Prescribers, patients,\nand pharmacies must be enrolled in the REMS program and comply with all\nrequirements (\nwww.filsparirems.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.filsparirems.com&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=www.filsparirems.com&index=3&md5=fea192f0967951eb7803b01c2a2d8bd8)\n\n).\n * Embryo-Fetal Toxicity: Based on data from animal reproduction studies,\nFILSPARI may cause fetal harm when administered to a pregnant patient and is\ncontraindicated during pregnancy. The available human data for ERAs do not\nestablish the presence or absence of fetal harm related to the use of\nFILSPARI. Counsel patients who can become pregnant of the potential risk to a\nfetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise\npatients who can become pregnant to use effective contraception prior to\ninitiation of treatment, during treatment, and for two weeks after\ndiscontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or\ntheir guardian(s) of the fetal risk and the need to use effective\ncontraception once they reach reproductive potential. When pregnancy is\ndetected, discontinue FILSPARI as soon as possible.\n * Hypotension: Hypotension has been observed in patients treated with ARBs and\nERAs and was observed in FILSPARI clinical studies. There was a greater\nincidence of hypotension-associated adverse events, some serious, including\ndizziness, in patients treated with FILSPARI compared to irbesartan. In\npatients at risk for hypotension, consider eliminating or adjusting other\nantihypertensive medications and maintaining appropriate volume status. If\nhypotension develops, despite elimination or reduction of other\nantihypertensive medications, consider a dose reduction or dose interruption\nof FILSPARI. A transient hypotensive response is not a contraindication to\nfurther dosing of FILSPARI, which can be given once blood pressure has\nstabilized.\n * Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit\nthe renin-angiotensin system (RAS) can cause kidney injury. Patients whose\nkidney function may depend in part on the activity of the RAS (e.g., patients\nwith renal artery stenosis, chronic kidney disease, severe congestive heart\nfailure, or volume depletion) may be at particular risk of developing acute\nkidney injury on FILSPARI. Consider withholding or discontinuing therapy in\npatients who develop a clinically significant decrease in kidney function\nwhile on FILSPARI.\n * Hyperkalemia: Monitor serum potassium periodically and treat appropriately.\nPatients with advanced kidney disease, taking concomitant potassium-increasing\ndrugs (e.g., potassium supplements, potassium-sparing diuretics), or using\npotassium-containing salt substitutes are at increased risk for developing\nhyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required.\n * Fluid Retention: Fluid retention may occur with ERAs and has been observed in\nclinical studies with FILSPARI. FILSPARI has not been evaluated in patients\nwith heart failure. If clinically significant fluid retention develops,\nevaluate the patient to determine the cause and the potential need to initiate\nor modify the dose of diuretic treatment then consider modifying the dose of\nFILSPARI.\nAdverse Reactions\n\n * IgAN patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare hyperkalemia, hypotension (including orthostatic hypotension), peripheral\nedema, dizziness, anemia, and acute kidney injury.\n * FSGS patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare peripheral edema, hypotension (including orthostatic hypotension),\nhyperkalemia, dizziness, and anemia.\nDrug Interactions\n\n * Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister\nFILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension,\nsyncope, hyperkalemia, and changes in renal function (including acute renal\nfailure).\n * Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with\nstrong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided,\ninterrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider\ndose titration. Monitor blood pressure, serum potassium, edema, and kidney\nfunction regularly when used concomitantly with moderate CYP3A inhibitors.\nConcomitant use with a strong CYP3A inhibitor increases sparsentan exposure\nwhich may increase the risk of FILSPARI adverse reactions.\n * Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer.\nConcomitant use with a strong CYP3A inducer decreases sparsentan exposure\nwhich may reduce FILSPARI efficacy.\n * Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective\nCyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal\nfunction with concomitant use with NSAIDs (including selective COX-2\ninhibitors). In patients with volume depletion (including those on diuretic\ntherapy) or with impaired kidney function, concomitant use of NSAIDs\n(including selective COX-2 inhibitors) with drugs that antagonize the\nangiotensin II receptor may result in deterioration of kidney function,\nincluding possible kidney failure. These effects are usually reversible.\n * CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently\nadministered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment\nin accordance with the Prescribing Information. Sparsentan is a weak inducer\nof CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases\nexposure of these substrates, which may reduce efficacy related to these\nsubstrates.\n * P-gp Substrates: Monitor for adverse reactions and consider dose reduction of\nP-gp substrates with narrow therapeutic indices when co-administered with\nFILSPARI. FILSPARI is a weak P-gp inhibitor and may increase plasma\nconcentrations of P-gp substrate drugs.\n * Agents Increasing Serum Potassium: Monitor serum potassium frequently in\npatients treated with FILSPARI and other agents that increase serum potassium.\nConcomitant use of FILSPARI with potassium-sparing diuretics, potassium\nsupplements, potassium-containing salt substitutes, or other drugs that raise\nserum potassium levels may result in hyperkalemia.\nPlease see the full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2Ffilspari-prescribing-information%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=Prescribing+Information&index=4&md5=596b4d859c4d1e0426b33f4f41551b17)\n, including BOXED WARNING, for additional Important Safety Information.\n\nForward Looking Statements\n\nThis press release contains “forward-looking statements” as that term is\ndefined in the Private Securities Litigation Reform Act of 1995. Without\nlimiting the foregoing, these statements are often identified by the words\n“on-track,” “positioned,” “look forward to,” “will,”\n“would,” “may,” “might,” “believes,” “anticipates,”\n“plans,” “expects,” “intends,” “potential,” or similar\nexpressions. In addition, expressions of strategies, intentions or plans are\nalso forward-looking statements. Such forward-looking statements include, but\nare not limited to, references to: statements relating to the clinical\nstudies, models and data described herein; statements regarding FILSPARI’s\npotential to modulate biological pathways and modify underlying disease\npathophysiology in IgAN; statements regarding FILSPARI’s potential benefits\nbeyond conventional RAS inhibition; and statements regarding evidence\nsupporting FILSPARI as foundational first-line treatment in IgAN. Such\nforward-looking statements are based on current expectations and involve\ninherent risks and uncertainties, including factors that could delay, divert\nor change any of them, and could cause actual outcomes and results to differ\nmaterially from current expectations. No forward-looking statement can be\nguaranteed. Among the factors that could cause actual results to differ\nmaterially from those indicated in the forward-looking statements are risks\nand uncertainties related to the studies and data described herein. The\nCompany also faces risks and uncertainties related to its business and\nfinances in general, the success of its commercial products, risks and\nuncertainties associated with its preclinical and clinical stage pipeline,\nrisks and uncertainties associated with the regulatory review and approval\nprocess, risks and uncertainties associated with enrollment of clinical trials\nfor rare diseases, and risks that ongoing or planned clinical trials may not\nsucceed or may be delayed for safety, regulatory or other reasons.\nSpecifically, the Company faces risks associated with the commercial launch of\nFILSPARI in FSGS and the ongoing commercialization in IgAN, the timing and\npotential outcome of its and its partners’ clinical studies, market\nacceptance of its commercial products including efficacy, safety, price,\nreimbursement, and benefit over competing therapies, risks related to the\nchallenges of manufacturing scale-up, risks associated with the successful\ndevelopment and execution of commercial strategies for such products,\nincluding FILSPARI, and risks and uncertainties related to the current\nadministration, including but not limited to risks and uncertainties related\nto tariffs and the funding, staffing and prioritization of resources at\ngovernment agencies including the FDA. The Company also faces the risk that it\nwill be unable to raise additional funding that may be required to complete\ndevelopment of any or all of its product candidates, including as a result of\nmacroeconomic conditions; risks relating to the Company’s dependence on\ncontractors for clinical drug supply and commercial manufacturing;\nuncertainties relating to patent protection and exclusivity periods and\nintellectual property rights of third parties; risks associated with\nregulatory interactions; and risks and uncertainties relating to competitive\nproducts, including current and potential future generic competition with\ncertain of the Company’s products, including potential ANDA filings or\npatent challenges, and technological changes that may limit demand for the\nCompany’s products. The Company also faces additional risks associated with\nglobal and macroeconomic conditions, including health epidemics and pandemics,\nincluding risks related to potential disruptions to clinical trials,\ncommercialization activity, supply chain, and manufacturing operations. You\nare cautioned not to place undue reliance on these forward-looking statements\nas there are important factors that could cause actual results to differ\nmaterially from those in forward-looking statements, many of which are beyond\nour control. The Company undertakes no obligation to publicly update any\nforward-looking statement, whether as a result of new information, future\nevents, or otherwise. Investors are referred to the full discussion of risks\nand uncertainties, including under the heading “Risk Factors”, as included\nin the Company’s most recent Form 10-K, Form 10-Q and other filings with the\nSecurities and Exchange Commission.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261023530930/en/\n(https://www.businesswire.com/news/home/20261023530930/en/)\n\nMedia:\n888-969-7879\nmediarelations@travere.com (mailto:mediarelations@travere.com)\n\nInvestors:\n888-969-7879\nIR@travere.com (mailto:IR@travere.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw5TMr18a-20261023","title":"Travere Presents New Biomarker Data at ASN Kidney Week Suggesting FILSPARI® (sparsentan) May Modify Underlying Disease Pathophysiology in IgA Nephropathy","author":"Business Wire","ticker":"TVTX","created":"2026-10-23T23:20:00.095Z","tickers":["TVTX"],"exchange":"NASDAQ","article_body":"Travere Presents New Biomarker Data at ASN Kidney Week Suggesting FILSPARI(®)\n(sparsentan) May Modify Underlying Disease Pathophysiology in IgA Nephropathy\n\nFILSPARI achieved greater reductions in biomarkers linked to kidney\ninflammation and injury than maximum labeled dose irbesartan\n\nFindings provide further evidence of the biological effects of dual endothelin\nand angiotensin receptor antagonism and support FILSPARI as foundational\ntreatment in IgAN \n\nTravere Therapeutics, Inc. (Nasdaq: TVTX) today presented new biomarker data\nfrom the Phase 3 PROTECT Study providing evidence that FILSPARI® (sparsentan)\nmay modify the underlying disease pathophysiology in people with IgA\nnephropathy (IgAN). Data were shared today in an oral presentation at the\nAmerican Society of Nephrology (ASN) Kidney Week 2026 in Denver, CO.\n\n“These biomarker data provide new insight into how FILSPARI’s dual\nmechanism of action may modify the underlying biology of IgA nephropathy,”\nsaid Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “When\nconsidered alongside the PROTECT results which demonstrated superior\nproteinuria reduction and a slower rate of kidney function decline compared\nwith maximum labeled dose irbesartan, as well as published real-world evidence\nshowing consistent outcomes in clinical practice, the totality of evidence\nsupports the use of FILSPARI as a non-immunosuppressive, kidney-targeted,\nfoundational first-line treatment for IgA nephropathy.”\n\nThe Phase 3 PROTECT Study was a global, randomized, multicenter, double-blind,\nactive-controlled clinical trial evaluating the safety and efficacy of\nFILSPARI, compared to irbesartan in 404 adult patients with IgAN. Of the\noverall study population, 295 patients participated in the biomarker analysis.\nAcross measured time points through Week 110, FILSPARI led to rapid and\nsustained reductions in all four urinary biomarkers evaluated.\n\n“These findings extend the exploratory signal observed in SPARTAN and show\nin a larger, randomized study that dual endothelin and angiotensin receptor\nantagonism may modulate several biological pathways associated with IgAN\npathophysiology,” said Chee Kay Cheung, M.B.Ch.B., Ph.D., consultant\nnephrologist at University Hospitals of Leicester NHS Trust.\n\nAt Week 110, least-squares mean percent changes from baseline, normalized to\nurine creatinine, were greater with FILSPARI than with irbesartan (reported p\nvalues are nominal):\n\n * sCD163, a marker of macrophage activation, decreased 60.1% with FILSPARI\nversus 26.0% with irbesartan, representing a 46.1% difference between\ntreatment arms (p<0.001).\n * BAFF, a marker of B-cell activation and survival, decreased 64.4% with\nFILSPARI versus 45.2% with irbesartan, representing a 34.9% difference between\ntreatment arms (p=0.02).\n * C5b-9, a marker of complement pathway activation, decreased 50.2% with\nFILSPARI versus 7.3% with irbesartan, representing a 46.3% difference between\ntreatment arms (p=0.032).\n * IL-6, a pro-inflammatory cytokine, decreased 45.4% with FILSPARI versus an\n8.7% increase with irbesartan, representing a 49.7% difference between\ntreatment arms (p<0.001).\nThe findings build on previously reported PROTECT results which demonstrated\nsuperior proteinuria reduction and a slower rate of kidney function decline\nwith FILSPARI compared with maximum labeled dose irbesartan. The consistency\nof effects across clinical outcomes and multiple biomarkers associated with\nIgAN disease biology provides further evidence that FILSPARI’s dual\nendothelin and angiotensin receptor antagonism may provide benefits beyond\nconventional RAS inhibition and supports its differentiated profile as an\nearly, foundational, non-immunosuppressive treatment for IgAN.\n\nMore information on Travere’s presence at ASN Kidney Week can be found here\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fmedicalaffairs.travere.com%2Fmeetings-events%2Fasn-kidney-week-2026%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=here&index=1&md5=d5104b6befd3370ba2cbaf645f9a7b23)\n.\n\nAbout the PROTECT Study\n\nThe Phase 3 PROTECT Study was a global, randomized, multicenter, double-blind,\nactive-controlled clinical trial evaluating the efficacy and safety of\nFILSPARI compared with maximum labeled dose irbesartan in 404 adults with\nbiopsy-confirmed IgAN. Participants had urine protein excretion (UPE) ≥1.0\ng/d and an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73\nm² despite optimized renin-angiotensin system inhibitor therapy. Participants\nwere randomized 1:1 to receive FILSPARI 400 mg/day or irbesartan 300 mg/day\nfor up to 110 weeks. The primary efficacy endpoint was the change in\nproteinuria from baseline at Week 36, and the key secondary efficacy endpoint\nwas the rate of change in eGFR through Week 110.\n\nAbout Travere Therapeutics\n\nAt Travere Therapeutics, we are in rare for life. We are a biopharmaceutical\ncompany that comes together every day to help patients, families and\ncaregivers of all backgrounds as they navigate life with a rare disease. On\nthis path, we know the need for treatment options is urgent – that is why\nour global team works with the rare disease community to identify, develop and\ndeliver life-changing therapies. In pursuit of this mission, we continuously\nseek to understand the diverse perspectives of rare patients and to\ncourageously forge new paths to make a difference in their lives and provide\nhope – today and tomorrow. For more information, visit travere.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=travere.com&index=2&md5=e10efee62a519272802e63557083b353)\n.\n\nFILSPARI(®) (sparsentan) U.S. Indication\n\nFILSPARI(®) (sparsentan) is indicated:\n\n * To slow kidney function decline in adults with primary immunoglobulin A\nnephropathy (IgAN) who are at risk for disease progression.\n * To reduce proteinuria in adult and pediatric patients aged 8 years and older\nwith focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY\n\nBecause of the risk of hepatotoxicity, FILSPARI is available only through a\nrestricted program called the FILSPARI REMS. Under the FILSPARI REMS,\nprescribers, patients and pharmacies must enroll in the program.\n\nHepatotoxicity\n\nSome Endothelin Receptor Antagonists (ERAs) have caused elevations of\naminotransferases, hepatotoxicity, and liver failure. In clinical studies,\nelevations in aminotransferases (ALT or AST) of at least 3-times the Upper\nLimit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated\npatients, including cases confirmed with rechallenge.\n\nMeasure transaminases and bilirubin before initiating treatment and then every\n3 months during treatment. Interrupt treatment and closely monitor patients\nwho develop aminotransferase elevations more than 3x ULN.\n\nFILSPARI should generally be avoided in patients with elevated\naminotransferases (>3x ULN) at baseline because monitoring for\nhepatotoxicity may be more difficult and these patients may be at increased\nrisk for serious hepatotoxicity.\n\nEmbryo-Fetal Toxicity\n\nFILSPARI is contraindicated for use during pregnancy because it may cause\nfetal harm if used by pregnant patients. Therefore, in patients who can become\npregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of\neffective contraception before the initiation of treatment, during treatment,\nand for two weeks after discontinuation of treatment with FILSPARI. When\npregnancy is detected, discontinue FILSPARI as soon as possible.\n\nContraindications\n\nFILSPARI is contraindicated in patients who are pregnant. Do not coadminister\nFILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.\n\nWarnings and Precautions\n\n * Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been\nobserved in up to 3.5% of FILSPARI-treated patients, including cases confirmed\nwith rechallenge. While no concurrent elevations in bilirubin >2-times ULN\nor cases of liver failure were observed in FILSPARI-treated patients in\nclinical trials, some ERAs have caused elevations of aminotransferases,\nhepatotoxicity, and liver failure. To reduce the risk of potential serious\nhepatotoxicity, measure serum aminotransferase levels and total bilirubin\nprior to initiation of treatment and then every 3 months during treatment.\n\nAdvise patients with symptoms suggesting hepatotoxicity (nausea, vomiting,\nright upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or\nitching) to immediately stop treatment with FILSPARI and seek medical\nattention. If aminotransferase levels are abnormal at any time during\ntreatment, interrupt FILSPARI and monitor as recommended.\n\nConsider re-initiation of FILSPARI only when hepatic enzyme levels and\nbilirubin return to pretreatment values and only in patients who have not\nexperienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI\nin patients with elevated aminotransferases (>3x ULN) because monitoring\nhepatotoxicity in these patients may be more difficult and these patients may\nbe at increased risk for serious hepatotoxicity.\n * FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only\nthrough a restricted program called the FILSPARI REMS. Prescribers, patients,\nand pharmacies must be enrolled in the REMS program and comply with all\nrequirements (\nwww.filsparirems.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.filsparirems.com&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=www.filsparirems.com&index=3&md5=fea192f0967951eb7803b01c2a2d8bd8)\n\n).\n * Embryo-Fetal Toxicity: Based on data from animal reproduction studies,\nFILSPARI may cause fetal harm when administered to a pregnant patient and is\ncontraindicated during pregnancy. The available human data for ERAs do not\nestablish the presence or absence of fetal harm related to the use of\nFILSPARI. Counsel patients who can become pregnant of the potential risk to a\nfetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise\npatients who can become pregnant to use effective contraception prior to\ninitiation of treatment, during treatment, and for two weeks after\ndiscontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or\ntheir guardian(s) of the fetal risk and the need to use effective\ncontraception once they reach reproductive potential. When pregnancy is\ndetected, discontinue FILSPARI as soon as possible.\n * Hypotension: Hypotension has been observed in patients treated with ARBs and\nERAs and was observed in FILSPARI clinical studies. There was a greater\nincidence of hypotension-associated adverse events, some serious, including\ndizziness, in patients treated with FILSPARI compared to irbesartan. In\npatients at risk for hypotension, consider eliminating or adjusting other\nantihypertensive medications and maintaining appropriate volume status. If\nhypotension develops, despite elimination or reduction of other\nantihypertensive medications, consider a dose reduction or dose interruption\nof FILSPARI. A transient hypotensive response is not a contraindication to\nfurther dosing of FILSPARI, which can be given once blood pressure has\nstabilized.\n * Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit\nthe renin-angiotensin system (RAS) can cause kidney injury. Patients whose\nkidney function may depend in part on the activity of the RAS (e.g., patients\nwith renal artery stenosis, chronic kidney disease, severe congestive heart\nfailure, or volume depletion) may be at particular risk of developing acute\nkidney injury on FILSPARI. Consider withholding or discontinuing therapy in\npatients who develop a clinically significant decrease in kidney function\nwhile on FILSPARI.\n * Hyperkalemia: Monitor serum potassium periodically and treat appropriately.\nPatients with advanced kidney disease, taking concomitant potassium-increasing\ndrugs (e.g., potassium supplements, potassium-sparing diuretics), or using\npotassium-containing salt substitutes are at increased risk for developing\nhyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required.\n * Fluid Retention: Fluid retention may occur with ERAs and has been observed in\nclinical studies with FILSPARI. FILSPARI has not been evaluated in patients\nwith heart failure. If clinically significant fluid retention develops,\nevaluate the patient to determine the cause and the potential need to initiate\nor modify the dose of diuretic treatment then consider modifying the dose of\nFILSPARI.\nAdverse Reactions\n\n * IgAN patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare hyperkalemia, hypotension (including orthostatic hypotension), peripheral\nedema, dizziness, anemia, and acute kidney injury.\n * FSGS patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare peripheral edema, hypotension (including orthostatic hypotension),\nhyperkalemia, dizziness, and anemia.\nDrug Interactions\n\n * Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister\nFILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension,\nsyncope, hyperkalemia, and changes in renal function (including acute renal\nfailure).\n * Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with\nstrong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided,\ninterrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider\ndose titration. Monitor blood pressure, serum potassium, edema, and kidney\nfunction regularly when used concomitantly with moderate CYP3A inhibitors.\nConcomitant use with a strong CYP3A inhibitor increases sparsentan exposure\nwhich may increase the risk of FILSPARI adverse reactions.\n * Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer.\nConcomitant use with a strong CYP3A inducer decreases sparsentan exposure\nwhich may reduce FILSPARI efficacy.\n * Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective\nCyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal\nfunction with concomitant use with NSAIDs (including selective COX-2\ninhibitors). In patients with volume depletion (including those on diuretic\ntherapy) or with impaired kidney function, concomitant use of NSAIDs\n(including selective COX-2 inhibitors) with drugs that antagonize the\nangiotensin II receptor may result in deterioration of kidney function,\nincluding possible kidney failure. These effects are usually reversible.\n * CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently\nadministered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment\nin accordance with the Prescribing Information. Sparsentan is a weak inducer\nof CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases\nexposure of these substrates, which may reduce efficacy related to these\nsubstrates.\n * P-gp Substrates: Monitor for adverse reactions and consider dose reduction of\nP-gp substrates with narrow therapeutic indices when co-administered with\nFILSPARI. FILSPARI is a weak P-gp inhibitor and may increase plasma\nconcentrations of P-gp substrate drugs.\n * Agents Increasing Serum Potassium: Monitor serum potassium frequently in\npatients treated with FILSPARI and other agents that increase serum potassium.\nConcomitant use of FILSPARI with potassium-sparing diuretics, potassium\nsupplements, potassium-containing salt substitutes, or other drugs that raise\nserum potassium levels may result in hyperkalemia.\nPlease see the full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2Ffilspari-prescribing-information%2F&esheet=54628069&newsitemid=20261023530930&lan=en-US&anchor=Prescribing+Information&index=4&md5=596b4d859c4d1e0426b33f4f41551b17)\n, including BOXED WARNING, for additional Important Safety Information.\n\nForward Looking Statements\n\nThis press release contains “forward-looking statements” as that term is\ndefined in the Private Securities Litigation Reform Act of 1995. Without\nlimiting the foregoing, these statements are often identified by the words\n“on-track,” “positioned,” “look forward to,” “will,”\n“would,” “may,” “might,” “believes,” “anticipates,”\n“plans,” “expects,” “intends,” “potential,” or similar\nexpressions. In addition, expressions of strategies, intentions or plans are\nalso forward-looking statements. Such forward-looking statements include, but\nare not limited to, references to: statements relating to the clinical\nstudies, models and data described herein; statements regarding FILSPARI’s\npotential to modulate biological pathways and modify underlying disease\npathophysiology in IgAN; statements regarding FILSPARI’s potential benefits\nbeyond conventional RAS inhibition; and statements regarding evidence\nsupporting FILSPARI as foundational first-line treatment in IgAN. Such\nforward-looking statements are based on current expectations and involve\ninherent risks and uncertainties, including factors that could delay, divert\nor change any of them, and could cause actual outcomes and results to differ\nmaterially from current expectations. No forward-looking statement can be\nguaranteed. Among the factors that could cause actual results to differ\nmaterially from those indicated in the forward-looking statements are risks\nand uncertainties related to the studies and data described herein. The\nCompany also faces risks and uncertainties related to its business and\nfinances in general, the success of its commercial products, risks and\nuncertainties associated with its preclinical and clinical stage pipeline,\nrisks and uncertainties associated with the regulatory review and approval\nprocess, risks and uncertainties associated with enrollment of clinical trials\nfor rare diseases, and risks that ongoing or planned clinical trials may not\nsucceed or may be delayed for safety, regulatory or other reasons.\nSpecifically, the Company faces risks associated with the commercial launch of\nFILSPARI in FSGS and the ongoing commercialization in IgAN, the timing and\npotential outcome of its and its partners’ clinical studies, market\nacceptance of its commercial products including efficacy, safety, price,\nreimbursement, and benefit over competing therapies, risks related to the\nchallenges of manufacturing scale-up, risks associated with the successful\ndevelopment and execution of commercial strategies for such products,\nincluding FILSPARI, and risks and uncertainties related to the current\nadministration, including but not limited to risks and uncertainties related\nto tariffs and the funding, staffing and prioritization of resources at\ngovernment agencies including the FDA. The Company also faces the risk that it\nwill be unable to raise additional funding that may be required to complete\ndevelopment of any or all of its product candidates, including as a result of\nmacroeconomic conditions; risks relating to the Company’s dependence on\ncontractors for clinical drug supply and commercial manufacturing;\nuncertainties relating to patent protection and exclusivity periods and\nintellectual property rights of third parties; risks associated with\nregulatory interactions; and risks and uncertainties relating to competitive\nproducts, including current and potential future generic competition with\ncertain of the Company’s products, including potential ANDA filings or\npatent challenges, and technological changes that may limit demand for the\nCompany’s products. The Company also faces additional risks associated with\nglobal and macroeconomic conditions, including health epidemics and pandemics,\nincluding risks related to potential disruptions to clinical trials,\ncommercialization activity, supply chain, and manufacturing operations. You\nare cautioned not to place undue reliance on these forward-looking statements\nas there are important factors that could cause actual results to differ\nmaterially from those in forward-looking statements, many of which are beyond\nour control. The Company undertakes no obligation to publicly update any\nforward-looking statement, whether as a result of new information, future\nevents, or otherwise. Investors are referred to the full discussion of risks\nand uncertainties, including under the heading “Risk Factors”, as included\nin the Company’s most recent Form 10-K, Form 10-Q and other filings with the\nSecurities and Exchange Commission.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261023530930/en/\n(https://www.businesswire.com/news/home/20261023530930/en/)\n\nMedia:\n888-969-7879\nmediarelations@travere.com (mailto:mediarelations@travere.com)\n\nInvestors:\n888-969-7879\nIR@travere.com (mailto:IR@travere.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-23T23:20:00.14922489Z","server_sent_at_ms":1792797600149},"received_at":"2026-10-23T23:20:00.322Z","source_url":"https://www.businesswire.com/news/home/20261023530930/en/"},"analysis":{"id":"166771","press_release_id":"178867","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Travere Therapeutics presented new Phase 3 PROTECT biomarker data at ASN Kidney Week 2026 showing FILSPARI achieved greater reductions in kidney inflammation and injury biomarkers than maximum-dose irbesartan in IgA nephropathy.\n\nAt Week 110, sCD163 fell 60.1% with FILSPARI vs 26.0% with irbesartan, C5b-9 fell 50.2% vs 7.3%, and IL-6 fell 45.4% while rising 8.7% on irbesartan (all nominal p-values significant).\n\nManagement argues the totality of evidence supports FILSPARI as a non-immunosuppressive, foundational first-line treatment for IgAN, reinforcing its commercial differentiation.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Biomarker differentiation story strengthens FILSPARI's first-line positioning in IgAN, but conference data is incremental rather than a catalyst."},"keyFigures":{"drugName":"FILSPARI (sparsentan)","phaseOfTrial":"Phase 3","customDimensions":{"study_enrollment":404,"study_duration_weeks":110,"il6_change_irbesartan":"8.7% increase","il6_reduction_filspari":"45.4%","baff_reduction_filspari":"64.4%","c5b9_reduction_filspari":"50.2%","baff_reduction_irbesartan":"45.2%","c5b9_reduction_irbesartan":"7.3%","sCD163_reduction_filspari":"60.1%","biomarker_analysis_patients":295,"sCD163_reduction_irbesartan":"26.0%"}},"quotedText":"These biomarker data provide new insight into how FILSPARI's dual mechanism of action may modify the underlying biology of IgA nephropathy","namedEntities":{"people":[{"name":"Jula Inrig, M.D.","role":"Chief Medical Officer, Travere Therapeutics"},{"name":"Chee Kay Cheung, M.B.Ch.B., Ph.D.","role":"Consultant nephrologist, University Hospitals of Leicester NHS Trust"}],"products":["FILSPARI (sparsentan)","irbesartan"],"companies":[{"name":"Travere Therapeutics, Inc.","ticker":"TVTX","relationship":"filer"},{"name":"American Society of Nephrology","relationship":"conference organizer"},{"name":"University Hospitals of Leicester NHS Trust","relationship":"investigator institution"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Conference presentation of exploratory biomarker data from the already-completed Phase 3 PROTECT study. Supportive of FILSPARI's differentiated profile but no new clinical outcomes, regulatory, or commercial events."},"tickerRelevance":{"others":[],"primary":"TVTX"},"globalImportance":22,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"dataNote":"nominal p-values only, biomarker endpoints not outcomes","tickerTier":"small-cap biotech","eventGravity":"conference biomarker data, exploratory","commercialRelevance":"supports existing launch, no new regulatory event"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Travere Therapeutics presented new Phase 3 PROTECT biomarker data at ASN Kidney Week 2026 showing FILSPARI achieved greater reductions in kidney inflammation and injury biomarkers than maximum-dose irbesartan in IgA nephropathy.\n\nAt Week 110, sCD163 fell 60.1% with FILSPARI vs 26.0% with irbesartan, C5b-9 fell 50.2% vs 7.3%, and IL-6 fell 45.4% while rising 8.7% on irbesartan (all nominal p-values significant).\n\nManagement argues the totality of evidence supports FILSPARI as a non-immunosuppressive, foundational first-line treatment for IgAN, reinforcing its commercial differentiation.","key_figures":{"drugName":"FILSPARI (sparsentan)","phaseOfTrial":"Phase 3","customDimensions":{"study_enrollment":404,"study_duration_weeks":110,"il6_change_irbesartan":"8.7% increase","il6_reduction_filspari":"45.4%","baff_reduction_filspari":"64.4%","c5b9_reduction_filspari":"50.2%","baff_reduction_irbesartan":"45.2%","c5b9_reduction_irbesartan":"7.3%","sCD163_reduction_filspari":"60.1%","biomarker_analysis_patients":295,"sCD163_reduction_irbesartan":"26.0%"}},"named_entities":{"people":[{"name":"Jula Inrig, M.D.","role":"Chief Medical Officer, Travere Therapeutics"},{"name":"Chee Kay Cheung, M.B.Ch.B., Ph.D.","role":"Consultant nephrologist, University Hospitals of Leicester NHS Trust"}],"products":["FILSPARI (sparsentan)","irbesartan"],"companies":[{"name":"Travere Therapeutics, Inc.","ticker":"TVTX","relationship":"filer"},{"name":"American Society of Nephrology","relationship":"conference organizer"},{"name":"University Hospitals of Leicester NHS Trust","relationship":"investigator institution"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-23T23:20:05.486Z","global_importance":22,"audience_relevance":25,"importance_components":{"dataNote":"nominal p-values only, biomarker endpoints not outcomes","tickerTier":"small-cap biotech","eventGravity":"conference biomarker data, exploratory","commercialRelevance":"supports existing launch, no new regulatory event"}},"durationMs":5144,"modelName":"glm-5.3-flashx"}}