Biogen (BIIB) Gains as LEQEMBI Wins Australian Approval for Early Alzheimer’s Treatment

• In September 2025, Eisai Co., Ltd. and Biogen Inc. announced that Australia's Therapeutic Goods Administration approved LEQEMBI, a monoclonal antibody treatment for early Alzheimer's disease, based on positive Phase 3 data.
• This approval, along with recent regulatory progress for subcutaneous dosing in the US and China, highlights global momentum in Biogen's Alzheimer's portfolio and expands access to new patient populations.
• We’ll explore how LEQEMBI’s international regulatory expansion could influence Biogen’s long-term growth narrative and earnings potential.

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Biogen Investment Narrative Recap

To own shares in Biogen, one has to believe in the long-term promise of its Alzheimer's drug LEQEMBI and the company’s ability to turn regulatory wins into significant revenue as global approvals add patients. Australia’s green light for LEQEMBI spotlights progress but does not meaningfully change the biggest risks, reliance on a small number of new launches, and intensifying biosimilar competition in the MS business, particularly outside the US, remain front and center.

The European Commission’s recent approval of ZURZUVAE for postpartum depression is particularly interesting. Like LEQEMBI, ZURZUVAE is a fresh launch expected to drive growth, though both rely heavily on sustained regulatory and commercial success, highlighting just how concentrated Biogen’s near-term pipeline risks and catalysts have become.

By contrast, investors may not fully appreciate the risk that any clinical or reimbursement setback for LEQEMBI could...

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

Biogen's narrative projects $9.4 billion in revenue and $2.1 billion in earnings by 2028. This requires a 2.1% annual revenue decline and a $0.6 billion earnings increase from the current level of $1.5 billion.

Uncover how Biogen's forecasts yield a $170.03 fair value, a 10% upside to its current price.

Exploring Other Perspectives

Seven Simply Wall St Community fair value estimates for Biogen range widely from US$100 to US$367.65 per share. With growth now tied closely to LEQEMBI’s global adoption and payer coverage, it pays to weigh these different viewpoints before forming your own outlook.

Explore 7 other fair value estimates on Biogen - why the stock might be worth over 2x more than the current price!

Build Your Own Biogen Narrative

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

• A great starting point for your Biogen research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Biogen research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Biogen's overall financial health at a glance.

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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.

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