Regeneron Pharmaceuticals (NasdaqGS:REGN) BLA Resubmission For Odronextamab In R/R FL Accepted By FDA

Regeneron Pharmaceuticals (NasdaqGS:REGN) recently received significant news with the FDA accepting the resubmission of the Biologics License Application for odronextamab, a potential treatment for certain lymphoma cases, marking an important regulatory milestone. This, alongside its steady revenue growth despite a drop in net income, likely influenced the company's 3.25% stock price increase over the past month. The initiation of a quarterly dividend program and recent share repurchase announcements may have further bolstered investor confidence. While major U.S. stock indexes experienced mixed performance due to broader economic concerns and announcements related to tariffs, Regeneron managed to maintain positive momentum. The general market saw a decline of 3.6% over the same period, indicating that Regeneron's positive company-specific developments possibly insulated it against broader market volatility. Overall, investor sentiment around Regeneron seems cautiously optimistic, as evidenced by its recent price performance in a challenging market backdrop.

Click to explore a detailed breakdown of our findings on Regeneron Pharmaceuticals.

The five-year period has seen Regeneron Pharmaceuticals achieve a total return of 43.44%, reflecting the company's resilience and innovation in the biotech sector. While the broader market experienced fluctuations, REGN's trajectory included several key developments that contributed to its performance. Specifically, the consistent growth in earnings—averaging 4.1% annually—set a foundation, despite the recent earnings fluctuation in early 2025. Strategic collaborations, such as the partnership with Immuneering Corporation announced in January 2025, expanded its research capabilities, potentially enhancing future growth prospects.

Product evolutions played a substantial role, highlighted by the FDA approval of Libtayo for lung cancer treatment in early 2022. Furthermore, the FDA acceptance of resubmissions for new pipeline products, such as those for odronextamab and linvoseltamab in early 2025, demonstrates ongoing progress in Regeneron's portfolio. Despite varying quarterly performances, these innovations imply a pathway of sustainable value creation, contributing significantly to the company's total return over the long term.

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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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