Expanded FDA Approvals and Pipeline Wins Could Be a Game Changer For Regeneron Pharmaceuticals (REGN)

• In November 2025, Regeneron Pharmaceuticals announced a series of major product milestones, including FDA approvals for EYLEA HD® in expanded indications and dosing regimens, and Libtayo as an adjuvant therapy for cutaneous squamous cell carcinoma, along with positive late-stage trial results for new treatments in hematology and immunology.
• These developments highlight Regeneron's ability to expand both its commercial portfolio and research pipeline across multiple therapeutic areas, underscoring ongoing diversification beyond its legacy products.
• We'll examine how the expanded FDA approval for EYLEA HD and new clinical trial successes impact Regeneron's investment narrative and future opportunities.

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Regeneron Pharmaceuticals Investment Narrative Recap

To be a shareholder in Regeneron, you need to believe in the company’s ability to both defend its core franchises and reinvent its pipeline as competition increases. The recent FDA approval of EYLEA HD for expanded indications and positive clinical data across immunology and oncology represents progress toward this, but the most important short-term catalyst, stabilizing EYLEA revenue as biosimilar pressures mount, remains highly sensitive to price competition and reimbursement risks. For now, the news neither fully resolves nor materially worsens those headline challenges.

Among the latest milestones, the FDA’s green light for EYLEA HD’s new dosing and expanded indications is especially relevant. This regulatory win could help counterbalance EYLEA’s competitive and pricing pressures if adoption increases, but any upside will depend on market uptake, continued reimbursement, and avoiding supply chain disruptions, a familiar risk for the stock’s core narrative around near-term revenue stability.

Yet, investors should not overlook the flip side: rising payer scrutiny and biosimilar erosion represent risks that could accelerate faster than some expect...

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

Regeneron Pharmaceuticals' narrative projects $16.6 billion revenue and $5.0 billion earnings by 2028. This requires 5.4% yearly revenue growth and a $0.5 billion earnings increase from $4.5 billion today.

Uncover how Regeneron Pharmaceuticals' forecasts yield a $753.17 fair value, a 7% upside to its current price.

Exploring Other Perspectives

Some of the highest analyst forecasts were expecting Regeneron’s revenues to reach US$17.8 billion in three years and earnings of US$6.2 billion, thanks to faster EYLEA HD adoption and expanding new therapies. These analysts present a much more optimistic view than the baseline, especially considering the possibility of quicker market share gains. With the latest approvals, you may want to consider how these new realities could shift those earlier expectations, investor outlooks can change quickly as fresh data surfaces.

Explore 10 other fair value estimates on Regeneron Pharmaceuticals - why the stock might be worth 23% less 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 3 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.