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TARRYTOWN, N.Y. - Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), a prominent biotechnology company with a market capitalization of $59 billion and annual revenue exceeding $14 billion, announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. According to InvestingPro analysis, Regeneron is currently trading below its Fair Value, suggesting potential upside opportunity.
The European Commission is expected to make a final decision on the application in the coming months. The U.S. Food and Drug Administration approved Libtayo for this indication earlier this month. With a strong financial health score rated as "GREAT" by InvestingPro and a comfortable current ratio of 4.6, Regeneron appears well-positioned to support this expansion.
The positive opinion is based on results from the global Phase 3 C-POST trial, which showed Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo. Fewer patients treated with Libtayo experienced locoregional recurrence (4% vs. 17%) or distant recurrence (5% vs. 13%) compared to those receiving placebo.
In the trial, adverse events occurred in 91% of patients receiving Libtayo and 89% of patients receiving placebo. Grade 3 or higher adverse events were reported in 24% of Libtayo patients versus 14% in the placebo group. The most common side effects included fatigue, pruritus, rash, diarrhea, arthralgia, hypothyroidism and maculo-papular rash.
The C-POST trial enrolled 415 patients who were randomized to receive either Libtayo or placebo for up to 48 weeks. Participants were considered high risk due to specific nodal features or other risk factors.
Cutaneous squamous cell carcinoma is one of the most common cancers worldwide, with incidence of non-melanoma skin cancers expected to increase by 40% in the EU by 2040.
This information is based on a press release statement from Regeneron Pharmaceuticals.
In other recent news, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Libtayo as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma following surgery and radiation. This approval is based on Phase 3 C-POST trial results, which indicated a 68% reduction in the risk of disease recurrence or death compared to a placebo. Additionally, Regeneron will present new data on Libtayo’s dosing regimen at the European Society for Medical Oncology 2025 Meeting, highlighting a potential every 6-week dosing schedule. Despite challenges facing Regeneron’s EYLEA franchise, Canaccord Genuity reiterated its Buy rating and maintained an $850 price target for the company. Cantor Fitzgerald also maintained its Overweight rating and $678 price target, noting that Regeneron’s third-quarter financial results were largely in line with expectations. Meanwhile, Scholar Rock faced a setback as the FDA flagged issues at a third-party manufacturing facility, potentially delaying its biologics license application resubmission. The facility’s inspection classification was labeled as "official action indicated" by the FDA, which could impact Scholar Rock’s production timelines.
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