Business
Travere Therapeutics Provides Corporate Update and 2023 Outlook
Company well-positioned for potential FDA Subpart H approval and commercial launch of sparsentan for IgA nephropathy (IgAN) in 1Q23, followed by potential EMA
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Company well-positioned for potential FDA Subpart H approval and commercial launch of sparsentan for IgA nephropathy (IgAN) in 1Q23, followed by potential EMA approval in second half of 2023 Preliminary net product sales of $201 million for the full year 2022 SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects net product sales for the fourth quarter of 2022 to be approximately $52 million. For the fiscal year 2022, the Company expects total revenue of $212 million, inclusive of approximately $201 million in net product sales and approximately $11 million in licensing and collaboration revenue. The Company ended 2022 with approximately $450 million in cash, cash equivalents and marketable securities. The Company also provided a general update on its development programs, including anticipated milestones for 2023. “This is a very exciting year for Travere and the rare disease community, with the first potential approvals from our development pipeline of therapies targeting rare diseases with significant unmet needs. We are focused and ready to execute on a successful U.S. commercial launch of sparsentan for IgAN in the first quarter, pending FDA approval following our upcoming PDUFA target action date of February 17, 2023,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “We also look forward to additional data from our Phase 3 DUPLEX Study of sparsentan which has the potential to support a supplemental NDA for FSGS, a condition that is currently lacking effective treatment options. Beyond sparsentan, we anticipate the initiation of a Phase 3 program for pegtibatinase, which continues to advance in clinical development with the goal of becoming the first disease-modifying therapy for people living with classical homocystinuria. We anticipate that 2023 will be a pivotal year for us as we pursue our mission of delivering life-changing therapies to people living with rare disease.” Program Updates and Anticipated 2023 Milestones In 2023, the Company anticipates the first regulatory approvals in the U.S. and Europe for sparsentan, the first and only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) in development for rare kidney disorders. If approved, sparsentan w...