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Travere Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results
Recently received U.S. FDA accelerated approval of FILSPARI™ (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Recently received U.S. FDA accelerated approval of FILSPARI™ (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy (IgAN) European Medicines Agency (EMA) review decision for potential conditional approval of sparsentan in IgAN anticipated in second half of 2023 Pivotal DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) on track to report topline data from confirmatory two-year endpoints in second quarter of 2023 Net product sales of $52 million for the fourth quarter of 2022; $201 million for the full year 2022 SAN DIEGO, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its fourth quarter and full year 2022 financial results and provided a corporate update. On February 17, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to FILSPARI™ (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gCommercial availability of FILSPARI expected the week of February 27, 2023Review decision by the EMA on the potential approval of the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN in Europe expected in second half 2023Topline data from the two-year confirmatory endpoints in the ongoing Phase 3 DUPLEX Study of sparsentan in FSGS expected in the second quarter of 2023Topline data from the two-year confirmatory endpoints in the ongoing Phase 3 PROTECT Study of sparsentan in IgAN expected in the fourth quarter of 2023Total revenue for the fourth quarter of 2022 was $55.9 million, consisting of $52.3 million in net product sales and $3.5 million in licensing and collaboration revenueTotal revenue for the full year 2022 was $212.0 million, consisting of $200.5 million in net product sales and $11.5 million in licensing and collaboration revenueCash, cash equivalents and marketable securities, as of December 31, 2022, totaled $450.2 million “2022 was a foundational year for Travere. We demonstrated clinical expertise with the advancement of our development programs, reached new patients with our approved products, and prepared our organization for a new phase of growth to deliver new medicines to rare disease patients,” said Eric Dube, Ph.D., chief...