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SEC filingTravere Therapeutics reported Q1 2026 financial results with FILSPARI sales up 88% to $105M, FDA approval in FSGS, and Phase 3 HARMONY study restart.
Travere Therapeutics reported strong first quarter 2026 results, driven by record demand for FILSPARI in IgA nephropathy (IgAN) and the recent FDA approval in focal segmental glomerulosclerosis (FSGS). U.S. net product sales of FILSPARI reached $105.2 million, an 88% increase year-over-year, reflecting 993 new patient start forms (PSFs) in the quarter. Total U.S. net product sales were $124.5 million, up from $75.9 million in the prior year. The company's GAAP net loss narrowed to $37.1 million ($0.40 per share) from $41.2 million ($0.47 per share) in Q1 2025, while on a non-GAAP adjusted basis, the company achieved net income of $4.1 million ($0.05 per share), compared to a net loss of $16.9 million ($0.19 per share) in the prior year. The improvement in non-GAAP profitability reflects revenue growth outpacing expense increases. R&D expenses rose to $57.1 million (GAAP) from $46.9 million, primarily due to the restart of the Phase 3 HARMONY study of pegtibatinase in classical homocystinuria (HCU). SG&A expenses increased to $80.3 million from $60.4 million, driven by investments in the FSGS launch and IgAN commercial activities. The company ended the quarter with $264.7 million in cash, cash equivalents, and marketable securities, excluding a $25 million milestone payment from Mirum Pharmaceuticals received in April 2026. Management highlighted the transformative nature of the FSGS approval, which expands FILSPARI's addressable U.S. patient population to over 100,000. The first FSGS patients were treated within a week of approval, and the company expects to present additional Phase 3 DUPLEX data at the NKF Spring Clinical Meeting. The Phase 3 HARMONY study of pegtibatinase has resumed enrollment, with the first new patient dosed in April 2026 and topline data anticipated in the second half of 2027. The company also noted that its partner Chugai Pharmaceutical expects to submit a New Drug Application for sparsentan in Japan in 2026, which could trigger milestone payments.