Travere Therapeutics presented new, late‑breaking data from its Phase 3 DUPLEX study of FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2025 in Houston, Texas. The poster session, held on November 6, 2025, highlighted the drug’s superior proteinuria reduction compared with the maximum labeled dose of irbesartan.
In the full DUPLEX cohort, 37.5 % of FILSPARI‑treated patients achieved a urine protein‑to‑creatinine ratio (UPCR) below 0.7 g/g at any time during the study, versus 21.4 % of patients receiving irbesartan. The overall reduction in UPCR was 50 % for FILSPARI versus 32 % for irbesartan, a 26 % relative improvement that translates into a 24 % lower projected five‑year risk of kidney failure for patients who reach the 0.7 g/g threshold.
A DUPLEX‑aligned cohort of 386 FSGS patients from the UK National Registry of Rare Kidney Disease (RaDaR) reinforced these findings. Modeling of that cohort indicated that the relative proteinuria reduction achieved with FILSPARI correlates with a 24 % reduction in the five‑year risk of kidney failure, underscoring the clinical relevance of the proteinuria endpoint.
The data strengthen Travere’s case for FDA approval of FILSPARI in FSGS, the first therapy to receive such approval for this rare disease. Travere has submitted a supplemental New Drug Application (sNDA) with a PDUFA target action date of January 13, 2026. If approved, FILSPARI would expand the company’s commercial portfolio beyond its already approved indication for IgA nephropathy, positioning it as a foundational therapy in two high‑unmet‑need kidney diseases.
Travere’s Q3 2025 financial results provide a solid foundation for the drug’s development and commercialization. Total revenue reached $164.9 million, driven by $113.2 million in U.S. net product sales of FILSPARI. Net income of $25.7 million marked a turnaround from a loss in the prior year, and the company reported $254.5 million in cash, cash equivalents, and marketable securities as of September 30, 2025.
Chief Executive Officer Eric Dube said, “We continue to be pleased with the progress of our sNDA review in FSGS and are actively preparing for a potential FDA approval early next year.” The announcement was met with positive market reaction, driven by the strong Q3 earnings and the anticipation of FDA approval, which analysts view as a significant milestone for the company’s growth trajectory.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.