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    Did Gedatolisib’s Phase 3 PFS and Tolerability Data Just Shift Celcuity’s (CELC) Investment Narrative?

    Simply Wall St·12/15/2025 19:24:56
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    • Celcuity Inc. recently reported updated Phase 3 VIKTORIA-1 results for its PAM inhibitor gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, highlighting substantial progression-free survival benefits over fulvestrant in multiple patient sub-groups and geographies.
    • An interesting feature of the data is the combination of extended progression-free survival with stable glucose levels and manageable stomatitis, underscoring a differentiated tolerability profile versus many targeted therapies in this setting.
    • We’ll now examine how gedatolisib’s progression-free survival gains and manageable side effects shape Celcuity’s investment narrative following the recent news.

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    What Is Celcuity's Investment Narrative?

    To own Celcuity, you have to believe gedatolisib can convert its late-stage clinical momentum into an approved, commercially meaningful therapy before funding and competition pressures bite too hard. The updated VIKTORIA-1 data from SABCS strengthens the near-term story by reinforcing earlier progression-free survival gains with cleaner safety, which supports the ongoing rolling NDA under the FDA’s RTOR program and keeps regulatory milestones front and center as the key catalysts. At the same time, the stock’s very large 12‑month move and premium price-to-book multiple suggest a lot of optimism is already reflected, while the company remains pre-revenue, loss-making and reliant on external capital. The new data may ease some efficacy and tolerability concerns, but it does little to lessen binary regulatory and financing risks.

    However, investors should also recognise how much future success is already priced in. Celcuity's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

    Exploring Other Perspectives

    CELC 1-Year Stock Price Chart
    CELC 1-Year Stock Price Chart

    The Simply Wall St Community’s single fair value estimate of US$488.70 per share contrasts sharply with Celcuity’s current pre-revenue status and rich valuation, inviting you to weigh breakthrough breast cancer data against ongoing approval, dilution and execution risks.

    Explore another fair value estimate on Celcuity - why the stock might be worth just $488.70!

    Build Your Own Celcuity 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.