Travere Therapeutics’ FDA Acceptance for FILSPARI Application

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

On May 15, 2025, Travere Therapeutics announced that the FDA accepted its supplemental New Drug Application for FILSPARI® (sparsentan) for treating focal segmental glomerulosclerosis (FSGS), with a target action date set for January 13, 2026. If approved, FILSPARI could become the first FDA-approved treatment for FSGS, a rare kidney disorder affecting over 40,000 patients in the U.S. The application is supported by the Phase 3 DUPLEX Study and Phase 2 DUET Study, which demonstrated significant benefits in reducing proteinuria and improving remission rates in FSGS patients.

The most recent analyst rating on (TVTX) stock is a Buy with a $16.00 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 presents a mixed outlook with significant revenue growth driven by FILSPARI sales, but persistent financial challenges and high leverage pose risks. Positive technical momentum and strategic progress from the earnings call are promising, but valuation remains unattractive due to ongoing losses. Overall, the stock score reflects a cautious stance given the financial instability and near-term headwinds.

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

More about Travere Therapeutics

Travere Therapeutics, Inc. operates in the biopharmaceutical industry, focusing on developing and commercializing therapies for rare diseases. The company’s primary products include treatments for kidney disorders, with a market focus on addressing unmet medical needs in rare diseases.

Average Trading Volume: 1,743,320

Technical Sentiment Signal: Strong Buy

Current Market Cap: $1.86B

Find detailed analytics on TVTX stock on TipRanks’ Stock Analysis page.