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    FDA Review Of Veli For Thyroid Eye Disease Might Change The Case For Investing In Viridian Therapeutics (VRDN)

    Simply Wall St·12/20/2025 18:11:03
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    • In recent days, analysts at firms including Goldman Sachs and Needham reiterated positive views on Viridian Therapeutics after the company submitted a Biologics License Application to the FDA for its lead thyroid eye disease therapy, veli.
    • These endorsements highlight how Viridian’s plan to convert existing Tepezza prescribers and potentially broaden veli’s label with Phase 3 data could reshape expectations for its rare disease portfolio.
    • With FDA review of veli’s application now underway, we’ll examine how this potential launch opportunity influences Viridian’s investment narrative.

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    What Is Viridian Therapeutics' Investment Narrative?

    For Viridian, the core “big picture” is straightforward: you have to believe that veli can secure approval in thyroid eye disease and become a meaningful alternative to Tepezza, while VRDN-003 follows as a second, possibly more convenient, option. The recent BLA submission and the follow-up boost from Goldman Sachs and Needham reinforce that the key near term catalyst is now the FDA review itself, rather than new data. A 5% share price move suggests the market sees this as incrementally positive, but not thesis changing. The business still lives with classic biotech risks: regulatory outcomes, the timing and shape of any veli label, and the need to fund a pipeline while losses remain large and the stock trades on a rich sales multiple.

    However, investors also need to consider how much dilution and cash burn may still lie ahead. Despite retreating, Viridian Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much.

    Exploring Other Perspectives

    VRDN Earnings & Revenue Growth as at Dec 2025
    VRDN Earnings & Revenue Growth as at Dec 2025
    Three Simply Wall St Community fair value views range from just US$0.18 to almost US$300, underlining how far opinions can stretch. Set that against today’s focus on veli’s FDA review and label outcome, and you can see why different investors may draw very different conclusions about Viridian’s long term potential.

    Explore 3 other fair value estimates on Viridian Therapeutics - why the stock might be worth over 9x more than the current price!

    Build Your Own Viridian Therapeutics Narrative

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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.