Business
Travere Therapeutics Reports Third Quarter 2022 Financial Results
EMA accepted for review the Conditional Marketing Authorization application for sparsentan for IgAN in Europe; review decision expected in second half of 2023
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"EMA accepted for review the Conditional Marketing Authorization application for sparsentan for IgAN in Europe; review decision expected in second half of 2023 New PDUFA target action date for sparsentan in IgAN set for February 17, 2023 Net product sales of $50.8 million for the third quarter of 2022 SAN DIEGO, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its third quarter 2022 financial results and provided a corporate update. European Medicines Agency (EMA) accepted for review the conditional marketing authorization (CMA) application for sparsentan for the treatment of IgAN in Europe; review decision on potential approval expected in second half of 2023U.S. Food and Drug Administration (FDA) confirmed three-month extension of New Drug Application (NDA) review process for sparsentan in IgA nephropathy (IgAN); new Prescription Drug User Fee Act (PDUFA) target action date of February 17, 2023, assignedBreakthrough Therapy Designation granted to pegtibatinase development program for classical homocystinuria (HCU)Total revenue for the third quarter 2022 was $53.5 million, consisting of $50.8 million in net product sales and $2.7 million in licensing and collaboration revenueCash, cash equivalents and marketable securities, as of September 30, 2022, totaled $506.3 million “During the third quarter we continued to execute towards our vision of being a leader in the global rare disease community,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Our IgA nephropathy and FSGS programs continue to advance with the goal of positioning sparsentan to become the first and only dual-acting, non-immunosuppressive treatment option for people living with rare kidney disorders. With the new PDUFA target action date confirmed in the U.S. and the acceptance of the CMA application in Europe in the third quarter, we are well positioned for potential approvals of sparsentan for the treatment of IgA nephropathy in both the U.S. and Europe next year. In the U.S., we have already built upon our strong commercial foundation to establish a field team with extensive nephrology experience. Additionally, we continue to look forward to the upcoming readout of our DUPLEX Study of sparsentan in FSGS in the first half of next year, as well as the potential to advance pegtibatinase...