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    FDA Manufacturing Letter And Backup Plant Plans Could Be A Game Changer For Scholar Rock (SRRK)

    Simply Wall St·12/03/2025 10:21:55
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    • Earlier in 2025, Scholar Rock Holding reported that its manufacturing partner Catalent Indiana received an FDA warning letter, yet the company still plans to resubmit its biologics license application and pursue a 2026 U.S. launch of apitegromab for spinal muscular atrophy, subject to regulatory approval.
    • Scholar Rock is also accelerating the transfer of commercial manufacturing capacity to a second facility, underscoring its effort to reduce regulatory risk around apitegromab’s potential commercialization.
    • We’ll now examine how the FDA warning letter and Scholar Rock’s contingency manufacturing plans shape the company’s investment narrative.

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    What Is Scholar Rock Holding's Investment Narrative?

    To own Scholar Rock today, you really have to believe that apitegromab can make the leap from a promising SMA therapy to an approved, commercially viable product before the cash burn becomes too heavy. The recent FDA warning letter to Catalent Indiana adds another layer to that bet, because it keeps regulatory execution front and center as the main short term catalyst and risk. The company’s plan to resubmit the BLA and push for a 2026 launch, while accelerating transfer to a second manufacturing site, shows it is trying to contain that risk rather than change course. Given the share price has held onto strong multi‑year gains despite deepening losses, the story now hinges even more on timing and quality of the FDA’s next response.

    However, one operational wrinkle could still have outsized consequences for shareholders. Despite retreating, Scholar Rock Holding's shares might still be trading above their fair value and there could be some more downside. Discover how much.

    Exploring Other Perspectives

    SRRK Earnings & Revenue Growth as at Dec 2025
    SRRK Earnings & Revenue Growth as at Dec 2025
    The single US$47.33 fair value estimate from the Simply Wall St Community leaves plenty of room for differing views. Against this, the regulatory uncertainty around apitegromab’s path to approval may influence how you think about execution risk and future performance.

    Explore another fair value estimate on Scholar Rock Holding - why the stock might be worth just $47.33!

    Build Your Own Scholar Rock Holding Narrative

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

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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.