On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) 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. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026.
The FDA approval is based on pivotal Phase 3 C-POST trial data.
Also Read: Regeneron Touts Positive Data From Phase 3 Study In Patients With Ultra-Rare Genetic Disorder
Data
The study showed that Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo in patients with CSCC at high risk of recurrence after surgery and radiation (hazard ratio [HR]: 0.32).
The approved supplemental Biologics License Application (sBLA) did not include Catalent Indiana, LLC as a filling site.
Recently, the FDA approved Regeneron’s Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).
Evkeeza was initially approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population.
REGN Price Action: Regeneron Pharmaceuticals shares were up 0.87% at $568.78 at the time of publication on Thursday, according to Benzinga Pro data.
Regeneron Pharmaceuticals, with a market cap of $61.41 billion, operates in the highly competitive biotechnology sector, where its P/E ratio of 14.21 suggests a valuation that is below the industry average, potentially indicating market skepticism about future growth.
The stock’s 52-week range, spanning from $476.48 to $1024.35, highlights significant volatility, particularly as it approaches the lower end, raising questions about investor confidence amid evolving market dynamics and competitive pressures.
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