Business
Travere Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results
NDA submission of sparsentan in IgA nephropathy on-track for first quarter 2022 Company positioned for potential NDA submission for accelerated approval of
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"NDA submission of sparsentan in IgA nephropathy on-track for first quarter 2022 Company positioned for potential NDA submission for accelerated approval of sparsentan in FSGS and combined IgA nephropathy and FSGS MAA submission mid-year 2022 Recently reported positive topline results from the ongoing Phase 1/2 COMPOSE Study of pegtibatinase in classical homocystinuria Net product sales increased six percent to $211 million for the full year 2021 SAN DIEGO, Feb. 24, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its fourth quarter and full year 2021 financial results and provided a corporate update. The Company is on-track to submit a New Drug Application (NDA) for accelerated approval of sparsentan in IgA nephropathy (IgAN) in the first quarter of 2022Preparations underway to submit NDA for accelerated approval of sparsentan for focal segmental glomerulosclerosis (FSGS) and combined IgAN and FSGS Marketing Authorisation Application (MAA), pending supportive estimated glomerular filtration (eGFR) data from ongoing Phase 3 DUPLEX StudyCompany is engaging with regulators to establish next steps for a pivotal development program for pegtibatinase following recently reported positive topline results from the ongoing Phase 1/2 COMPOSE StudyNet product sales for the fourth quarter 2021 were $54.6 million, compared to $51.0 million for the same period in 2020Total revenue for the full year 2021 was $227.5 million, consisting of $210.8 million in net product sales and $16.7 million in licensing and collaboration revenueCash, cash equivalents and marketable securities, as of December 31, 2021, totaled $552.9 million “2021 was an outstanding year for Travere. Our pipeline of potential first in class rare disease treatments delivered three positive topline readouts from our ongoing studies and we established regulatory pathways to potential accelerated approvals in both IgA nephropathy and FSGS for sparsentan. We also continued to execute with our commercial products, achieving six percent organic growth in net product sales for the year,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “We are carrying this positive momentum into 2022. We remain on-track for our planned regulatory submissions, including the NDA for sparsentan in IgA nephropathy in the first quarter. We also look fo...