Street Calls of the Week
TARRYTOWN, N.Y. - Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), a prominent biotechnology company with a market capitalization of $59.37 billion and strong financial health metrics according to InvestingPro, will present new data from its oncology pipeline at the European Society for Medical Oncology (ESMO) 2025 Meeting in Berlin from October 17-21, according to a press release issued Wednesday.
The presentations will include Phase 3 C-POST trial data on an every 6-week dosing regimen for Libtayo (cemiplimab) as adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) with high risk of recurrence. This new dosing option could offer greater convenience for patients compared to the current 3-week schedule. The company’s strong research initiatives are supported by robust financials, with annual revenue of $14.2 billion and healthy profit margins of 47.35%.
The C-POST trial data shows that patients initially received Libtayo or placebo intravenously at 350 mg every 3 weeks for 12 weeks, with most patients then switching to every 6-week dosing. Treatment continued until disease recurrence, unacceptable toxicity, or up to 48 weeks.
According to the company, efficacy, pharmacokinetics and immunogenicity were similar across both dosing regimens, with safety profiles consistent with known data for Libtayo monotherapy in advanced cancers.
The U.S. Food and Drug Administration recently approved Libtayo as the first immunotherapy for adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
Regeneron will also present data on Libtayo in lung cancer, ubamatamab for platinum-resistant ovarian cancer, and REGN7075, an EGFRxCD28 bispecific antibody, among other research findings.
Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T cells and has been approved in more than 30 countries for various indications including advanced basal cell carcinoma, CSCC, non-small cell lung cancer, and advanced cervical cancer.
The information in this article is based on a press release statement from Regeneron Pharmaceuticals. Trading at a P/E ratio of 14.44 and currently showing signs of undervaluation based on InvestingPro’s Fair Value analysis, Regeneron presents an interesting case for investors. For deeper insights into Regeneron’s financial health, growth prospects, and expert analysis, access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers along with 8 additional ProTips and extensive financial metrics.
In other recent news, Regeneron Pharmaceuticals has received approval from the U.S. Food and Drug Administration for its drug Libtayo as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery and radiation. This approval was based on the Phase 3 C-POST trial results, which showed a 68% reduction in the risk of disease recurrence or death compared to a placebo. Additionally, Cantor Fitzgerald has reiterated its Overweight rating on Regeneron, highlighting that the company’s third-quarter financial results were in line with expectations. Canaccord Genuity also maintained its Buy rating on Regeneron, despite acknowledging challenges with its EYLEA franchise.
Meanwhile, Scholar Rock faces regulatory challenges after the FDA flagged issues at a third-party manufacturing facility used by the company. The FDA’s "official action indicated" classification for the Novo Nordisk-owned Catalent Indiana facility might delay Scholar Rock’s biologics license application resubmission. This development comes after a Form 483 was issued to the facility, indicating potential compliance issues that need addressing. These recent developments highlight significant regulatory and financial activities impacting both Regeneron Pharmaceuticals and Scholar Rock.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.