Business
Travere Therapeutics Provides Corporate Update and 2021 Outlook
Pipeline of potential first-in-class therapies on track to deliver two pivotal readouts in 2021 SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Travere
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Pipeline of potential first-in-class therapies on track to deliver two pivotal readouts in 2021\nSAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects net product sales for the fourth quarter of 2020 to be approximately $51 million. For the fiscal year 2020, the Company expects total net product sales of approximately $199 million. The Company also provided a general update on its development programs, including anticipated milestones for 2021. “We are entering 2021 with great momentum as we continue on our path to potentially delivering new, first-in-class treatment options for people living with rare disease,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “Our focus remains clear on maximizing the potential for sparsentan, if approved, to shape the treatment paradigm for patients living with rare kidney conditions FSGS and IgA nephropathy. The pivotal DUPLEX and PROTECT studies of sparsentan remain on track to report topline results from the interim proteinuria assessments, potentially positioning us for accelerated approval regulatory submissions in FSGS this year, followed by IgA nephropathy as early as next year. Additionally, we expect proof-of-concept data from the ongoing Phase 1/2 clinical trial of TVT-058 later this year, as we look to develop the first disease modifying therapy for people living with classical homocystinuria.” Program Updates and Anticipated Upcoming Milestones The Company continues to advance sparsentan, an investigational product candidate that is an innovative, single molecule that selectively inhibits both endothelin type A and angiotensin type II receptors, with the goal of having it ultimately become a new treatment standard in rare kidney conditions. The following upcoming milestones in the pivotal DUPLEX and PROTECT studies are anticipated in 2021: The Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) is on track to report topline efficacy data from the 36-week interim proteinuria endpoint analysis in February 2021.Successful achievement of the interim proteinuria endpoint in the DUPLEX Study is expected to serve as the basis for submission of a New Drug Application (NDA) under the Subpart H accelerated approval pathway ...