Business
Travere Therapeutics Reports Third Quarter 2021 Financial Results and Organizational Progress
Recently reported positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy Following pre-NDA
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Recently reported positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy Following pre-NDA interactions with FDA, NDA submission of sparsentan in IgA nephropathy for accelerated approval under Subpart H expected in the first quarter of 2022 Based on FDA interactions, accelerated approval submission of sparsentan in FSGS planned for mid-2022, pending additional supportive eGFR data from the ongoing DUPLEX Study Joint collaboration with Vifor Pharma to commercialize sparsentan in Europe; combined IgA nephropathy and FSGS MAA submission for sparsentan in Europe expected mid-2022 Net product sales of $54.2 million for the third quarter of 2021 SAN DIEGO, Oct. 28, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its third quarter 2021 financial results and provided a corporate update. In August 2021, the Company reported that the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy (IgAN) met its pre-specified interim primary efficacy endpoint, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p","length":1714,"tagName":"div"}]