New FDA approval for Libtayo

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) revealed that the US Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026. Regeneron emphasized that Libtayo is now the first and only immunotherapy approved for this adjuvant CSCC setting.

The market’s muted response to the approval indicated limited short-term momentum following the announcement. Analysts noted that the decline may reflect profit-taking or broader market softness in biotech stocks. Regeneron’s long-term prospects remain supported by expanding indications for Libtayo. The company’s continued leadership in immuno-oncology reinforces its strategic position within the competitive PD-1 inhibitor landscape.