Why Travere Therapeutics (TVTX) Shares Are Trading Lower Today - Travere Therapeutics (NASDAQ:TVTX)

Travere Therapeutics Inc TVTX completed its planned FDA Type A meeting for a potential submission for accelerated approval of sparsentan for focal segmental glomerulosclerosis (FSGS), a rare disease affecting the kidney filters.
FDA indicated that the interim analysis from the ongoing Phase 3 DUPLEX study and the recent limited additional estimated glomerular filtration (eGFR) data-cut do not meet their threshold to support an application for accelerated approval in FSGS.
The FDA indicated that the DUPLEX Study maintains the potential for full approval pending completion of the study and recommends that the company pursue traditional approval based on a two-year eGFR slope.
Travere anticipates having topline data from the DUPLEX Study, including full two-year eGFR data, in 1H of 2023 and filing for full approval in 2H of 2023.
The company completed a mid-cycle review meeting with the FDA for its marketing application under priority review for accelerated approval of sparsentan for IgA nephropathy.
The FDA indicated that no advisory committee meeting is expected, and it remains on track for the PDUFA target action date of November 17.
The company and its partner Vifor Pharma are applying for conditional marketing authorization of sparsentan for IgAN in Europe. Review decision expected in 2H of 2023.
Price Action: TVTX shares traded 6.25% lower at $22.50 premarket on the last check Thursday.

FDA Says Travere's Sparsentan Data Not Sufficient For Accelerated Approval In One Indication