TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN), a prominent player in the biotechnology sector with annual revenue of $13.8 billion, has reported positive outcomes from the Phase 3 C-POST trial, which evaluated the efficacy of the immunotherapy drug Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. The trial met its primary endpoint, demonstrating a 68% reduction in the risk of disease recurrence or death when compared to a placebo. According to InvestingPro analysis, Regeneron maintains strong financial health with robust cash flows and minimal debt exposure.
The C-POST study involved 415 patients who were randomized to receive either Libtayo or a placebo for up to 48 weeks. The primary measure of success, disease-free survival (DFS), showed significant improvement with Libtayo treatment. The median follow-up period was 24 months, during which the drug's safety profile was also assessed. Although adverse events were reported in 91% of the Libtayo group and 89% of the placebo group, more severe events occurred in 24% of those treated with Libtayo, compared to 14% with placebo. With the stock currently trading near its 52-week low, InvestingPro data suggests the company is undervalued, supported by its strong profit margins of over 50%.
The trial will continue for further analysis, including overall survival as a key secondary endpoint. These findings are expected to be presented at a medical conference and submitted to the U.S. Food and Drug Administration (FDA) in the first half of 2025.
Libtayo is already established as a standard of care for certain patients with advanced CSCC. However, its potential new application as an adjuvant treatment is based on investigational use, and its safety and efficacy have not yet been evaluated by regulatory authorities for this indication.
This news follows a recent Phase 3 trial where Keytruda®, another immunotherapy, failed to show similar benefits in the same setting. The success of Libtayo in this trial could represent a significant advancement in treatment options for patients at high risk of CSCC recurrence post-surgery.
The results of this trial are based on a press release statement from Regeneron Pharmaceuticals, Inc.
In other recent news, Regeneron Pharmaceuticals has seen a revision in analyst outlooks and promising trial results. Oppenheimer analysts adjusted their price target to $950 from $1,000, but still recommend the stock as an Outperform. This comes amid concerns about the company's primary product, EYLEA, facing competition from Amgen (NASDAQ:AMGN)'s biosimilar version. A conducted survey, however, indicated that the market erosion might be less severe than consensus expectations, hinting at a possible stabilization in the near future.
Similarly, RBC Capital Markets adjusted its price target on Regeneron shares, decreasing it from $1,215.00 to $1,184.00, while maintaining an Outperform rating. The firm highlighted the competitive strength of Regeneron's Eylea and the potential for EyleaHD, an enhanced version of the drug, to contribute to the company's growth.
Regeneron also reported successful results from the Phase 3 QUASAR trial of EYLEA HD, a treatment for macular edema following retinal vein occlusion. The trial demonstrated that EYLEA HD showed non-inferior vision gains compared to the standard EYLEA treatment, with patients needing fewer doses. The company plans to submit a supplementary biologics license application for EYLEA HD to the U.S. Food and Drug Administration in the first quarter of 2025. These are the recent developments for Regeneron Pharmaceuticals.
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