Accelerated FDA Approval of Lynozyfic May Change the Case for Investing in Regeneron (REGN)

• Regeneron Pharmaceuticals recently received accelerated FDA approval for Lynozyfic (linvoseltamab-gcpt) to treat adults with relapsed or refractory multiple myeloma who have undergone at least four prior therapies, addressing a significant medical need in oncology.
• This regulatory milestone not only bolsters Regeneron's late-stage cancer portfolio but also overcomes earlier manufacturing challenges that delayed approval, enhancing the company's outlook in a competitive therapeutic area.
• We'll examine how Regeneron's accelerated launch for Lynozyfic could reshape its longer-term growth narrative and late-stage pipeline opportunities.

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Regeneron Pharmaceuticals Investment Narrative Recap

To be a Regeneron shareholder, you have to believe in the company’s strength in innovation and its expanding drug pipeline to offset competitive and pricing pressure on established franchises like EYLEA. The recent FDA accelerated approval for Lynozyfic is an important pipeline win, but it is not likely to materially shift the immediate catalyst for the stock or alleviate the biggest business risk: continued competition and falling revenue from EYLEA in the US.

The related approval of Dupixent for bullous pemphigoid also stands out, as it reflects progress in diversifying revenue streams beyond EYLEA. This helps balance the near-term and long-term outlook, especially with pipeline setbacks and index removals keeping investor focus on execution. Despite these pipeline wins, risks from manufacturing and third-party dependencies still loom large for Regeneron investors...

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

Regeneron Pharmaceuticals' narrative projects $16.3 billion in revenue and $4.7 billion in earnings by 2028. This requires 5.1% yearly revenue growth and a $0.2 billion earnings increase from $4.5 billion today.

Uncover how Regeneron Pharmaceuticals' forecasts yield a $797.91 fair value, a 41% upside to its current price.

Exploring Other Perspectives

If you’re following the more optimistic analysts, you’ll notice they expected Regeneron’s annual revenue to hit US$17,300,000,000 and profits to reach US$5,800,000,000 by 2028, projecting pipeline catalysts like new drug approvals would sharply accelerate growth. Compared to the baseline consensus, these highest analyst estimates assume Regeneron can successfully manage competitive decline in EYLEA and unlock much higher earnings. These views show that opinions on Regeneron’s future can differ significantly, especially as recent news might shift the balance between risk and opportunity.

Explore 8 other fair value estimates on Regeneron Pharmaceuticals - why the stock might be worth over 3x more than the current price!

Build Your Own Regeneron Pharmaceuticals 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 Regeneron Pharmaceuticals research is our analysis highlighting 5 key rewards that could impact your investment decision.
• Our free Regeneron Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Regeneron Pharmaceuticals' 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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