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    The Bull Case For Cytokinetics (CYTK) Could Change Following Positive CHMP Opinion On MYQORZO Approval - Learn Why

    Simply Wall St·12/14/2025 18:25:37
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    • Cytokinetics recently reported that the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending EU marketing authorization for MYQORZO (aficamten) to treat symptomatic obstructive hypertrophic cardiomyopathy in adults, with a final European Commission decision expected in early 2026.
    • This positive opinion, underpinned by Phase 3 SEQUOIA-HCM data showing clinically meaningful gains in exercise capacity and a favorable safety profile, further validates aficamten as a potential new standard-of-care option in this specialist cardiology segment.
    • We’ll now examine how this positive CHMP opinion, backed by robust SEQUOIA-HCM outcomes, could reshape Cytokinetics’ existing investment narrative.

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    Cytokinetics Investment Narrative Recap

    To own Cytokinetics, you have to believe aficamten can transition from a late stage pipeline asset to a globally approved, commercially relevant oHCM therapy. The EMA’s positive CHMP opinion supports that thesis and reinforces the near term regulatory catalyst around the FDA’s December 2025 PDUFA date, but it does not remove the core execution risks around approval timing, reimbursement, and eventual uptake in a competitive cardiomyopathy market.

    Among recent developments, the class action complaint filed in October 2025 around aficamten NDA timing and REMS disclosures sits closest to this CHMP milestone, since both touch on how regulators frame aficamten’s risk profile and labeling. While litigation does not directly alter clinical data or regulatory reviews, it adds another layer of uncertainty to an already high stakes approval and commercialization path for Cytokinetics’ lead asset.

    Yet investors should also be aware that, despite the positive CHMP view, the unresolved REMS and legal overhang could still...

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

    Cytokinetics' narrative projects $649.5 million revenue and $90.6 million earnings by 2028. This requires 96.4% yearly revenue growth and about a $697 million earnings increase from -$606.3 million today.

    Uncover how Cytokinetics' forecasts yield a $79.56 fair value, a 26% upside to its current price.

    Exploring Other Perspectives

    CYTK 1-Year Stock Price Chart
    CYTK 1-Year Stock Price Chart

    Five fair value estimates from the Simply Wall St Community span roughly US$1.82 to US$112.91 per share, showing how far apart individual views can be. When you set this wide dispersion against Cytokinetics’ dependence on timely, successful aficamten approvals across major regions, it underlines why many readers may want to review several different risk and reward scenarios before forming a view.

    Explore 5 other fair value estimates on Cytokinetics - why the stock might be worth as much as 78% more than the current price!

    Build Your Own Cytokinetics Narrative

    Disagree with existing narratives? Create your own 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.