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    BioCryst Pharmaceuticals (BCRX) Is Up 8.0% After FDA Clears First Oral HAE Prophylaxis For Children

    Simply Wall St·12/25/2025 03:52:00
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    • BioCryst Pharmaceuticals previously announced that the FDA approved its New Drug Application for an oral pellet formulation of once-daily ORLADEYO (berotralstat) as the first targeted oral prophylactic therapy for hereditary angioedema in children aged 2 to under 12 years in the U.S.
    • This pediatric-friendly oral option addresses a long-standing gap where younger hereditary angioedema patients relied solely on intravenous or subcutaneous treatments, potentially easing daily treatment burden for families.
    • Next, we’ll consider how this first-in-class oral pediatric approval for ORLADEYO could influence BioCryst’s rare disease investment narrative.

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    BioCryst Pharmaceuticals Investment Narrative Recap

    To own BioCryst, you need to believe ORLADEYO can support a focused rare disease franchise while the pipeline matures and the balance sheet improves. The new pediatric oral pellet approval directly reinforces the near term ORLADEYO growth story, but it does not remove the core risk that revenue is still highly concentrated in a single HAE product amid rising competition and a planned exit from Europe.

    The most directly connected development is the FDA’s acceptance and ultimate approval of pediatric ORLADEYO formulations, which had been a key regulatory catalyst flagged by analysts. With that milestone now achieved, the conversation shifts to how effectively BioCryst can convert this broader label into sustained prescription growth, while managing the financial and operational impact of divesting its European business.

    Yet, investors should also be aware that BioCryst’s heavy dependence on ORLADEYO leaves the company exposed if...

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

    BioCryst Pharmaceuticals' narrative projects $777.6 million revenue and $212.3 million earnings by 2028. This requires 11.7% yearly revenue growth and a $248.0 million earnings increase from -$35.7 million today.

    Uncover how BioCryst Pharmaceuticals' forecasts yield a $20.40 fair value, a 165% upside to its current price.

    Exploring Other Perspectives

    BCRX 1-Year Stock Price Chart
    BCRX 1-Year Stock Price Chart

    Five fair value estimates from the Simply Wall St Community span roughly US$3.53 to US$66.76 per share, reflecting sharply different expectations. When you weigh those views against BioCryst’s reliance on ORLADEYO amid intensifying HAE competition, it underlines why many market participants scrutinize the concentration risk before forming an opinion.

    Explore 5 other fair value estimates on BioCryst Pharmaceuticals - why the stock might be worth over 8x more than the current price!

    Build Your Own BioCryst 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.