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

Regeneron Pharmaceuticals announced major milestones in November 2025, including FDA approvals for EYLEA HD in expanded indications and Libtayo as an adjuvant therapy for cutaneous squamous cell carcinoma. Positive late-stage trial results in hematology and immunology were also reported. These developments highlight Regeneron's expanding commercial portfolio and research pipeline. The FDA approval for EYLEA HD's new dosing and expanded indications is particularly significant, potentially counterbalancing competitive pressures. However, risks such as payer scrutiny and biosimilar erosion remain. Analysts have varied revenue and earnings forecasts for Regeneron.
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