Regeneron (REGN) Is Up After FDA Approves Libtayo as First Adjuvant Immunotherapy for High-Risk CSCC

• Regeneron Pharmaceuticals recently announced that the U.S. FDA approved Libtayo (cemiplimab-rwlc) as the first immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation, following evaluation under Priority Review and strong Phase 3 C-POST trial results.
• This approval introduces a new treatment option for earlier-stage high-risk CSCC patients and further consolidates Regeneron's oncology portfolio, backed by clinical data showing a very large reduction in risk of disease recurrence or death compared to placebo.
• We'll explore how FDA approval of Libtayo for adjuvant CSCC shifts Regeneron's investment narrative and potential long-term growth outlook.

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Regeneron Pharmaceuticals Investment Narrative Recap

For those considering Regeneron Pharmaceuticals, the central thesis rests on belief in the strength of its pipeline and ability to offset pressures from biosimilar and branded competition in core drugs like EYLEA. The FDA’s new approval for Libtayo as adjuvant therapy in high-risk CSCC highlights the company’s expanding oncology franchise, but the most crucial near-term catalyst, resolution of EYLEA HD’s manufacturing setbacks, remains unchanged. The biggest risk continues to be ongoing pricing and competitive threats in retinal disease.

Among recent announcements, the FDA’s acceptance of Evkeeza for young children with HoFH is the most relevant, as it underscores Regeneron’s efforts to expand its portfolio into rare diseases, further diversifying revenue streams and reducing risk linked to mature franchises.

But even with these scientific wins, investors should be aware that the risks around EYLEA’s ongoing branded and biosimilar competition have not disappeared...

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

Regeneron Pharmaceuticals' outlook anticipates $16.6 billion in revenue and $5.0 billion in earnings by 2028. This implies a 5.4% annual revenue growth and a $0.5 billion increase in earnings from the current $4.5 billion.

Uncover how Regeneron Pharmaceuticals' forecasts yield a $722.20 fair value, a 28% upside to its current price.

Exploring Other Perspectives

Some analysts are far more optimistic, projecting revenues as high as US$17,800,000,000 by 2028 and expecting margin expansion if advanced therapies like Libtayo take off. These bulls see less risk in pipeline productivity and believe Regeneron could grow faster than consensus suggests. It’s worth considering that these high estimates were set before this latest breakthrough, so the impact could shift opinions in either direction.

Explore 10 other fair value estimates on Regeneron Pharmaceuticals - why the stock might be worth over 2x 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 4 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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