Business
Travere Therapeutics Provides Corporate Update and 2022 Outlook
Company positioned for multiple NDA and MAA submissions for accelerated approval in 2022 SAN DIEGO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Company positioned for multiple NDA and MAA submissions for accelerated approval in 2022\nSAN DIEGO, Jan. 10, 2022 (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 2021 to be approximately $55 million. For the fiscal year 2021, the Company expects total revenue of $227 million, inclusive of approximately $211 million in net product sales and approximately $16 million in licensing and collaboration revenue. The Company also provided a general update on its development programs, including anticipated milestones for 2022. “Following three positive readouts from our pipeline and continued strong execution from our commercial business last year, we enter 2022 with great confidence in our ability to deliver new life-changing therapies to people living with rare disease,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “We are driven by the potential to make sparsentan a new treatment standard for people living with rare kidney diseases IgA nephropathy and FSGS, if approved. We remain on track for our planned NDA and MAA submissions, the first of which could result in an approval of sparsentan for IgA nephropathy in the U.S. as early as the end of this year. Additionally, with recent clinical proof of concept supporting pegtibatinase, we are in position to engage with regulators and establish the next steps for a pivotal program to further advance this therapy as the first potential treatment targeting the underlying deficiency in classical homocystinuria.” Program Updates and Anticipated Upcoming Milestones The Company continues to advance its investigational Dual Endothelin Angiotensin Receptor Antagonist (DEARA) sparsentan for the treatment of IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS) following previously reported positive topline interim results from the ongoing pivotal Phase 3 PROTECT and DUPLEX studies. The following upcoming milestones are anticipated in 2022: In the first quarter of 2022, the Company expects to submit a New Drug Application (NDA) for accelerated approval of sparsentan for IgAN in the U.S. In the first half of 2022, the Company plans to provide additional estimated glomerular filtration rate (eGFR) data from the ongoing ...