FDA Extends Review Timeline for Travere’s FILSPARI sNDA

Travere Therapeutics ( (TVTX) ) has issued an announcement.

On January 13, 2026, Travere Therapeutics announced that the U.S. Food and Drug Administration extended the review timeline for the supplemental New Drug Application for FILSPARI in focal segmental glomerulosclerosis, moving the target action date to April 13, 2026 after the company submitted additional data to further characterize the drug’s clinical benefit. The FDA classified these new materials as a Major Amendment but did not request further safety or manufacturing information, and the filing rests on clinical evidence from the large Phase 3 DUPLEX study and Phase 2 DUET study, which showed significant reductions in proteinuria and clinically meaningful benefits versus irbesartan despite DUPLEX not meeting its primary eGFR slope endpoint, underscoring both the potential of FILSPARI to become the first indicated therapy for FSGS and the regulatory scrutiny around demonstrating long‑term kidney function outcomes in this rare disease population.

The most recent analyst rating on (TVTX) stock is a Hold with a $31.00 price target. To see the full list of analyst forecasts on Travere Therapeutics stock, see the TVTX Stock Forecast page.

Spark’s Take on TVTX Stock

According to Spark, TipRanks’ AI Analyst, TVTX is a Neutral.

Travere Therapeutics’ overall stock score reflects strong earnings call performance and positive technical indicators, offset by weak financial performance and valuation concerns. The potential FDA approval for FILSPARI is a significant positive factor, but high leverage and lack of profitability remain critical risks.

To see Spark’s full report on TVTX stock, click here.

More about Travere Therapeutics

Travere Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing therapies for rare kidney diseases, including IgA nephropathy and focal segmental glomerulosclerosis (FSGS). Its lead product, FILSPARI (sparsentan), is an oral, non-immunosuppressive therapy fully approved by the U.S. Food and Drug Administration and the European Medicines Agency to slow kidney function decline in adults with IgA nephropathy, and is being investigated as a potential first approved pharmacologic treatment for FSGS, a serious proteinuric kidney disorder with no current FDA‑approved therapies.

Average Trading Volume: 1,941,707

Technical Sentiment Signal: Buy

Current Market Cap: $3.09B

For detailed information about TVTX stock, go to TipRanks’ Stock Analysis page.