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    Why Agios Pharmaceuticals (AGIO) Is Up 14.6% After First-in-Class Thalassemia Drug AQVESME Wins FDA Approval

    Simply Wall St·12/25/2025 01:41:05
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    • Agios Pharmaceuticals has now received U.S. FDA approval for AQVESME (mitapivat) to treat anemia in adults with alpha- or beta-thalassemia, covering both non-transfusion-dependent and transfusion-dependent patients, with U.S. availability expected after implementation of a required REMS program in late January 2026.
    • The approval, grounded in positive ENERGIZE and ENERGIZE-T Phase 3 data showing reduced transfusion burden and better quality-of-life measures, transforms AQVESME into a new branded option in a previously untreated segment of the thalassemia market.
    • We’ll now examine how AQVESME’s first-in-class thalassemia approval reshapes Agios’s reliance on mitapivat within its investment narrative.

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    Agios Pharmaceuticals Investment Narrative Recap

    To own Agios today, you have to believe mitapivat can evolve into a durable rare-disease franchise while the company manages ongoing losses and high spending. AQVESME’s first-in-class thalassemia approval meaningfully de-risks the near term launch catalyst, but leaves safety, uptake, and cost control as central questions for the story.

    Among recent developments, the EMA’s CHMP positive opinion for PYRUKYND in thalassemia outside the U.S. ties directly into this approval, reinforcing the idea that mitapivat is becoming a global thalassemia brand. Together, U.S. and potential European launches increase the importance of how quickly Agios can convert these regulatory wins into revenue that offsets its persistent operating losses.

    However, while AQVESME’s approval is encouraging, investors should also be aware that...

    Read the full narrative on Agios Pharmaceuticals (it's free!)

    Agios Pharmaceuticals' narrative projects $416.9 million revenue and $67.0 million earnings by 2028. This requires 116.9% yearly revenue growth and a $583.1 million earnings decrease from $650.1 million today.

    Uncover how Agios Pharmaceuticals' forecasts yield a $32.12 fair value, a 10% upside to its current price.

    Exploring Other Perspectives

    AGIO 1-Year Stock Price Chart
    AGIO 1-Year Stock Price Chart

    Simply Wall St Community members have published 2 fair value estimates for Agios, ranging widely from US$32.13 to US$346.09 per share, showing how differently people are modeling its potential. As you weigh those views against the company’s continued high R&D and SG&A spending and its lack of near term profitability, it is worth comparing several perspectives before deciding how AQVESME’s approval might affect Agios’s longer term performance.

    Explore 2 other fair value estimates on Agios Pharmaceuticals - why the stock might be worth just $32.12!

    Build Your Own Agios Pharmaceuticals 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.