Travere Therapeutics Reports Record FILSPARI Performance in 4Q 2025, Advances Regulatory and Clinical Milestones Ahead of 2026
Travere Therapeutics a biopharmaceutical company focused on developing and delivering transformative therapies for people living with rare kidney and metabolic diseases, today announced strong commercial results for FILSPARI® (sparsentan) and provided an update on its corporate, clinical, and regulatory initiatives, including anticipated milestones for 2026. The update is based on preliminary and unaudited financial data for the fourth quarter and full year ended December 31, 2025.
The Company reported that it expects total U.S. net product sales of approximately $127 million for the fourth quarter of 2025, driven primarily by continued growth of FILSPARI in IgA nephropathy (IgAN). For the full fiscal year 2025, Travere expects total U.S. net product sales of approximately $410 million. The Company ended 2025 with a strong balance sheet, including approximately $323 million in cash, cash equivalents, and marketable securities, positioning it to support ongoing commercial execution, regulatory activities, and pipeline advancement.
Record Commercial Momentum for FILSPARI in IgAN
During the fourth quarter of 2025, FILSPARI achieved record demand in the U.S. market. The Company received 908 new patient start forms (PSFs) during the quarter, representing the highest quarterly total since launch and reflecting continued uptake among both new and repeat prescribers. Preliminary U.S. net product sales of FILSPARI totaled approximately $103 million in 4Q 2025, representing 108% year-over-year growth. For the full year 2025, FILSPARI generated approximately $322 million in U.S. net product sales.
“The fourth quarter closed out an exceptional year of commercial execution with FILSPARI, as our teams were able to reach a record number of patients with IgA nephropathy, reinforcing its role as foundational therapy,” said Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics. “As we move into 2026, we are focused on sustaining this momentum while preparing for a successful commercial launch of FILSPARI in FSGS, which, if approved, would be the first approved medication for these patients facing potential kidney failure.”
FILSPARI is currently approved in the U.S. to slow kidney function decline in adults with primary IgA nephropathy who are at risk for disease progression. The continued growth in patient starts reflects increasing physician confidence in FILSPARI’s clinical profile and growing awareness of the importance of early intervention in progressive kidney disease.
Global Expansion and Partner Milestones
In October 2025, Travere received a $40 million milestone payment from its collaborator CSL Vifor following the achievement of specific market access milestones. CSL Vifor has launched FILSPARI in several European markets, including Germany, Austria, Switzerland, Luxembourg, and the United Kingdom. Travere remains eligible to receive additional market access and sales-based milestone payments under its collaboration agreement.
In parallel, Travere’s partner Chugai Pharmaceutical expects to submit a New Drug Application (NDA) for sparsentan in Japan in 2026. Upon approval, Travere would be eligible for additional regulatory, development, and sales-based milestone payments, as well as tiered royalties on net sales in Japan.
Looking ahead, Travere plans to continue generating clinical evidence to support FILSPARI’s role as foundational therapy in IgAN through ongoing and planned studies, real-world data analyses, and presentations at major nephrology and medical conferences in 2026.
FILSPARI in FSGS: Regulatory Review Underway
Travere is also advancing FILSPARI for the treatment of focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder that is a leading cause of kidney failure. The Company’s supplemental New Drug Application (sNDA) seeking full FDA approval for FILSPARI in FSGS has a PDUFA target action date of January 13, 2026.
The Company recently received additional information requests from the U.S. Food and Drug Administration (FDA) aimed at further characterizing the clinical benefit of FILSPARI in FSGS patients. Travere has submitted responses addressing the Agency’s questions, which are currently under review.
If approved, FILSPARI would become the first and only FDA-approved medication for FSGS, representing a significant advancement for patients who currently have limited treatment options. Travere stated that it is well positioned for a successful commercial launch in FSGS, if approval is granted, leveraging its existing nephrology-focused commercial infrastructure.
Pegtibatinase Program Advances Toward Phase 3 Restart
Beyond FILSPARI, Travere continues to advance its pipeline with a focus on rare metabolic diseases. Following further optimization of its manufacturing process in 2025, the Company is on track to restart the pivotal Phase 3 HARMONY Study of pegtibatinase in classical homocystinuria (HCU) in the first quarter of 2026.
Classical HCU is a rare, inherited metabolic disorder associated with serious and life-threatening complications. Pegtibatinase has the potential to become the first disease-modifying therapy for people living with classical HCU, addressing a significant unmet medical need.
“This marks an important next step in advancing our pipeline and delivering the first potentially disease-modifying therapy for people living with classical HCU,” added Dr. Dube.
Important Safety Information for FILSPARI
FILSPARI carries a BOXED WARNING for hepatotoxicity and embryo-fetal toxicity. Due to the risk of serious liver injury, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must enroll and comply with all program requirements.
In clinical studies, elevations in aminotransferases (ALT or AST) of at least three times the upper limit of normal (ULN) were observed in up to 3.5% of FILSPARI-treated patients. Liver function tests must be obtained prior to treatment initiation and monitored every three months during therapy. FILSPARI is contraindicated during pregnancy due to the risk of fetal harm and should not be coadministered with angiotensin receptor blockers (ARBs), endothelin receptor antagonists (ERAs), or aliskiren.
The most common adverse reactions (≥5%) include hyperkalemia, hypotension, peripheral edema, dizziness, anemia, and acute kidney injury.
Healthcare providers are advised to review the full Prescribing Information, including the BOXED WARNING, for complete safety and dosing guidance.
Financial Strength and Outlook
Travere’s strong commercial performance in 2025 has strengthened its financial position and provides flexibility to support its strategic priorities in 2026. The Company expects to announce its complete full-year 2025 financial results and provide a comprehensive corporate update in February 2026.
Travere will also present at the 44th Annual J.P. Morgan Healthcare Conference, where management will discuss the Company’s commercial progress, regulatory outlook, and pipeline strategy.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, expectations regarding continued commercial growth of FILSPARI, potential FDA approval and launch in FSGS, the timing and outcome of regulatory reviews, the restart of the Phase 3 HARMONY Study, and future financial performance. Actual results may differ materially due to risks and uncertainties, including regulatory outcomes, market acceptance, manufacturing challenges, and macroeconomic factors. Travere undertakes no obligation to update forward-looking statements except as required by law.
About Preliminary Financial Results
The preliminary results set forth above are unaudited, are based on management’s initial review of the Company’s results for the quarter and year ended December 31, 2025, and are subject to revision based upon the Company’s year-end closing procedures and the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results following the completion of year-end closing procedures, final adjustments or other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of the Company’s financial results for the year ended December 31, 2025, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.
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.
