How Investors May Respond To CSL (ASX:CSL) Gaining Canadian Approval for ANDEMBRY in Rare Disease Market

Simply Wall St.
Yesterday
  • CSL recently announced that Health Canada granted marketing authorization for ANDEMBRY (garadacimab), a monoclonal antibody for the routine prevention of hereditary angioedema attacks in patients aged 12 years and older.
  • This regulatory milestone gives CSL access to the Canadian HAE market with a product that showed very large reductions in attack frequency and sustained safety in pivotal studies.
  • We'll examine how ANDEMBRY's approval in Canada could strengthen CSL's position and growth strategy in the rare disease sector.

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CSL Investment Narrative Recap

For long-term CSL shareholders, belief in the company's ability to drive growth through innovation in rare disease treatments is essential. The recent Canadian approval of ANDEMBRY, while reinforcing CSL's leadership in the HAE space, does not materially shift the most immediate catalysts or the key risk, specifically, the competitive pressure from declining immunization rates in the U.S. flu vaccine segment.

The FDA approval of ANDEMBRY just two months prior is especially relevant, highlighting regulatory momentum for CSL’s lead products in major markets and supporting its rare diseases growth catalyst.

Yet, despite these developments, investors should stay mindful that profit margins may still be vulnerable if growth from new products does not offset recent declines in established immunization revenue streams and...

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

CSL's outlook projects $18.6 billion in revenue and $4.2 billion in earnings by 2028. This forecast is based on 6.8% yearly revenue growth and a $1.5 billion increase in earnings from the current $2.7 billion.

Uncover how CSL's forecasts yield a A$310.38 fair value, a 17% upside to its current price.

Exploring Other Perspectives

ASX:CSL Community Fair Values as at Aug 2025

Seventeen private investor fair value estimates from the Simply Wall St Community span a wide A$240 to A$469 range. Recent rare disease therapy approvals could be key for future performance, but the risk remains that growth in new launches might not fully compensate for weaker segments, check out how others see this balance playing out.

Explore 17 other fair value estimates on CSL - why the stock might be worth as much as 77% more than the current price!

Build Your Own CSL 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 CSL research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.
  • Our free CSL research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate CSL'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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