Business
Travere Therapeutics Reports Second Quarter 2021 Financial Results
Company expects to submit an application for conditional marketing authorization of sparsentan for FSGS in Europe before year-end 2021 Pivotal PROTECT Study
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Company expects to submit an application for conditional marketing authorization of sparsentan for FSGS in Europe before year-end 2021 Pivotal PROTECT Study of sparsentan in IgA nephropathy on track to report topline data from interim 36-week proteinuria endpoint in August 2021 Net product sales of $54.6 million for the second quarter of 2021 SAN DIEGO, July 29, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its second quarter 2021 financial results and provided a corporate update. Following interactions with the European Medicines Agency (EMA) during the second quarter of 2021, the Company expects to submit an application for conditional marketing authorization (CMA) of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) in Europe before year-end 2021The Phase 3 PROTECT Study of sparsentan in IgA nephropathy (IgAN) completed patient enrollment in the second quarter of 2021; topline data from the 36-week interim proteinuria analysis are on track for August 2021Net product sales for the second quarter 2021 were $54.6 million, compared to $48.4 million for the same period in 2020Cash, cash equivalents and marketable securities, as of June 30, 2021, totaled $522.8 million “We remain steadfast in our commitment to advancing toward our goal of delivering sparsentan as a potential new treatment standard for people living with FSGS and IgAN,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “We are encouraged by recent interactions with EMA, and we remain on-track to submit an application for conditional marketing authorization for FSGS in Europe later this year. As previously announced, we’ve adjusted our U.S. timelines for FSGS and look forward to our upcoming Type A meeting with the FDA to further our collaborative discussions on the potential to stay on an accelerated approval pathway. Next month, we are looking forward to the upcoming topline results from our Phase 3 PROTECT Study of sparsentan in IgA nephropathy, which if successful, would contribute to the growing body of evidence for sparsentan in rare kidney disorders, and potentially support submissions for accelerated approval in the U.S. and conditional marketing authorization in Europe.” Quarter Ended June 30, 2021 Net product sales for the second quarter of 2021 were $54.6 million, compared to...