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    Arrowhead Pharmaceuticals (ARWR) Is Up 22.0% After FDA Grants Breakthrough Status to Plozasiran

    Simply Wall St·12/09/2025 02:14:13
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    • Arrowhead Pharmaceuticals recently reported that the FDA granted Breakthrough Therapy designation to its investigational RNAi drug plozasiran as an add-on to diet for adults with severe hypertriglyceridemia, while also outlining plans to complete multiple Phase 3 trials by mid‑2026 and submit an sNDA by year‑end 2026.
    • This recognition, together with REDEMPLO already approved for familial chylomicronemia syndrome, strengthens Arrowhead’s position in triglyceride‑lowering therapies targeting patients with very limited treatment alternatives.
    • Next, we’ll examine how Breakthrough Therapy status for plozasiran may reshape Arrowhead’s investment narrative around cardiometabolic RNAi therapies.

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    Arrowhead Pharmaceuticals Investment Narrative Recap

    For Arrowhead, the core investment case now hinges on whether its cardiometabolic RNAi platform can convert promising science into durable, commercial products. The Breakthrough Therapy designation for plozasiran sharpens that focus, potentially accelerating its severe hypertriglyceridemia program, but it also raises the stakes around regulatory outcomes, which remain the most important near term catalyst and key risk for the story.

    Among recent announcements, the US$829.45 million in full year 2025 sales, driven largely by collaboration and milestone revenue, stands out. It highlights how dependent Arrowhead’s current financial profile is on partner payments, which can be volatile compared with the more predictable revenue that would come from a broader commercial rollout of plozasiran and other late stage assets.

    Yet even with FDA Breakthrough status, investors should be aware that...

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

    Arrowhead Pharmaceuticals’ narrative projects $398.8 million in revenue and $64.0 million in earnings by 2028.

    Uncover how Arrowhead Pharmaceuticals' forecasts yield a $57.67 fair value, a 16% downside to its current price.

    Exploring Other Perspectives

    ARWR 1-Year Stock Price Chart
    ARWR 1-Year Stock Price Chart

    Three fair value estimates from the Simply Wall St Community span a wide range, from as low as US$0.33 up to about US$58.96, underscoring how differently you might assess Arrowhead. Against that backdrop, the heightened regulatory risk around multiple Phase 3 programs and pending approvals could play a decisive role in how the company’s future performance ultimately aligns with any of these viewpoints.

    Explore 3 other fair value estimates on Arrowhead Pharmaceuticals - why the stock might be worth as much as $58.96!

    Build Your Own Arrowhead 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.