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Investing.com - Jefferies maintained its Buy rating and $35.00 price target on Travere Therapeutics (NASDAQ:TVTX), currently trading at $27.31 and showing significant momentum with a 10.35% gain over the past week, following the cancellation of an FDA advisory committee meeting for the company’s FSGS indication. According to InvestingPro data, the stock is trading near its 52-week high with strong recent performance.
The research firm views the advisory committee cancellation as a significant positive development for Travere, suggesting that the FDA is fully supportive of using UPCR (urine protein-to-creatinine ratio) as the primary endpoint for full approval in focal segmental glomerulosclerosis (FSGS).
Jefferies noted that after discussions with Travere management, the company remains confident in securing FDA approval for Filsapri to treat FSGS patients.
The PDUFA date of January 13, 2026, remains unchanged, though Jefferies believes approval could potentially come earlier than scheduled.
The firm reiterated its $35 price target for Travere Therapeutics stock as it approaches what Jefferies considers a likely approval for the FSGS indication.
In other recent news, Travere Therapeutics has seen several significant developments. The company announced that the FDA no longer requires an advisory committee meeting for its supplemental New Drug Application (sNDA) for Sparsentan and Filspari, both targeting focal segmental glomerulosclerosis (FSGS). The Prescription Drug User Fee Act (PDUFA) date for a decision on these applications remains January 13, 2026. This decision follows the acceptance of the sNDAs earlier this year. Additionally, the FDA has approved reduced monitoring requirements for FILSPARI, a treatment for IgA nephropathy, reducing the frequency of liver function tests and removing the embryo-fetal toxicity monitoring requirement. Analyst firm Cantor Fitzgerald reiterated its Overweight rating on Travere shares following these announcements. Furthermore, H.C. Wainwright maintained its Buy rating and $47.00 price target for Travere after presenting positive long-term data from a study on pegtibatinase, a treatment candidate for classical homocystinuria. This data showed significant reductions in total homocysteine and methionine levels in patients over 50 weeks.
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