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    Travere Therapeutics (TVTX) Is Up 18.9% After FDA Moves Ease Path For FILSPARI’s FSGS Expansion

    Simply Wall St·12/25/2025 01:33:55
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    • In December 2025, Travere Therapeutics reported a series of favorable FDA updates for FILSPARI, including the cancellation of an advisory committee review, easing of REMS requirements, and growing regulatory acceptance of proteinuria reduction as a key endpoint ahead of a January 2026 decision on expanding its use to focal segmental glomerulosclerosis (FSGS).
    • These regulatory developments highlight how Travere’s lead kidney drug could potentially broaden its reach in an area with limited treatment options, while concentrating the company’s prospects around a single, highly consequential approval outcome.
    • We’ll now examine how the FDA’s supportive stance on proteinuria endpoints and FILSPARI’s potential FSGS label expansion may reshape Travere’s investment narrative.

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    Travere Therapeutics Investment Narrative Recap

    To own Travere Therapeutics today, you need to believe FILSPARI can anchor a rare kidney disease franchise while the company manages losses and balance sheet risk. The recent FDA updates on FILSPARI and proteinuria endpoints sharpen that focus around the January 2026 FSGS decision, which now looks even more central as the key near term catalyst and single biggest regulatory swing factor for the business.

    The FDA’s cancellation of an advisory committee for FILSPARI’s FSGS filing and relaxation of REMS monitoring tie directly into this catalyst, reinforcing how much value now rides on one drug and one approval path. At the same time, the stock’s sharp move to a 52 week high on this news highlights how expectations are building into that binary event, while Travere is still unprofitable and carrying meaningful financial risk.

    Yet while the FDA tone has turned more constructive, investors still need to be aware of how Travere’s heavy reliance on FILSPARI leaves them exposed if...

    Read the full narrative on Travere Therapeutics (it's free!)

    Travere Therapeutics’ narrative projects $832.7 million revenue and $221.2 million earnings by 2028. This requires 35.6% yearly revenue growth and a $390.2 million earnings increase from -$169.0 million today.

    Uncover how Travere Therapeutics' forecasts yield a $41.50 fair value, a 3% upside to its current price.

    Exploring Other Perspectives

    TVTX 1-Year Stock Price Chart
    TVTX 1-Year Stock Price Chart

    Ten members of the Simply Wall St Community now value Travere anywhere between US$19.04 and US$143.45 per share, underlining how far apart individual views can be. Against that wide spread, the concentration of the story in a single, high impact FILSPARI FSGS decision gives you a clear focal point to test your own expectations for the company’s future performance.

    Explore 10 other fair value estimates on Travere Therapeutics - why the stock might be worth less than half the current price!

    Build Your Own Travere Therapeutics Narrative

    Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

    • A great starting point for your Travere Therapeutics research is our analysis highlighting 2 key rewards that could impact your investment decision.
    • Our free Travere Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Travere Therapeutics' overall financial health at a glance.

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.