TARRYTOWN, N.Y. – Regeneron (NASDAQ:) Pharmaceuticals, Inc. (NASDAQ: REGN) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its investigational drug odronextamab.
This recommendation is for conditional marketing authorization to treat adults with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after at least two lines of systemic therapy.
The European Commission will make a final decision on the authorization of odronextamab in the upcoming months. Follicular lymphoma and diffuse large B-cell lymphoma are the two most prevalent forms of B-cell non-Hodgkin lymphoma, with an estimated 120,000 and 163,000 new cases diagnosed globally each year, respectively.
The CHMP’s favorable opinion was supported by data from the Phase 1 ELM-1 and Phase 2 ELM-2 clinical trials, which showed significant and enduring response rates and an acceptable safety profile in adults with these types of lymphoma. The trials reported that the most frequent severe adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and fever.
Odronextamab, which has not yet been approved by any regulatory authority, is designed to target CD20 on cancer cells and CD3 on T cells, promoting the destruction of cancer cells. Regeneron’s ongoing clinical development for odronextamab includes the ELM-1 and ELM-2 studies, as well as the Phase 3 OLYMPIA program, which is evaluating the drug in earlier lines of therapy and additional B-cell non-Hodgkin lymphomas.
In addition to monotherapy, odronextamab is being studied in combination with other treatments, including a costimulatory bispecific antibody, REGN5837, and Regeneron’s PD-1 inhibitor, cemiplimab, in aggressive B-cell non-Hodgkin lymphomas.
Regeneron’s commitment to hematology extends beyond odronextamab, with a focus on developing bispecific antibodies and exploring various therapeutic modalities for blood cancers and rare blood disorders.
This news is based on a press release statement from Regeneron Pharmaceuticals. The company’s research and potential treatments are part of its broader mission to develop life-transforming medicines for serious diseases, leveraging its proprietary technologies and platforms. The anticipation surrounding odronextamab’s potential approval reflects the ongoing need for effective treatments for challenging hematologic conditions.
In other recent news, several key developments have occurred at Regeneron Pharmaceuticals. The company has seen favorable adjustments to its stock price targets from Argus Research and RBC Capital, who raised their targets to $1,170 and $1,200 respectively, while TD Cowen and BMO Capital maintained their Buy ratings and price targets. These adjustments come amid anticipation of a strong year for Regeneron, particularly due to promising regulatory decisions.
Regeneron’s drug Kevzara received FDA approval for treatment of children with active polyarticular juvenile idiopathic arthritis, broadening the treatment options for this condition. Other significant advancements include potential FDA and European Commission approvals for linvoseltamab and Dupixent, along with an expanded approval for cholesterol-lowering medication Praluent.
Analysts from multiple firms have highlighted the company’s promising pipeline, including the obesity treatment mibavademab, and the sustained growth of Eylea HD and Dupixent. Despite a delay in the approval process for Dupixent as a treatment for Chronic Obstructive Pulmonary Disease, BMO Capital still predicts the drug to generate $2.9 billion in sales for this condition.
These recent developments underscore the ongoing advancements and positive sentiment surrounding Regeneron Pharmaceuticals.
InvestingPro Insights
As Regeneron Pharmaceuticals (NASDAQ: REGN) awaits the European Commission’s decision on odronextamab, the company’s financial robustness and market performance continue to be of interest to investors. Regeneron boasts a substantial market capitalization of $115.35 billion, underscoring its significant presence in the biotechnology industry—a status reinforced by its position as a prominent player in the field, according to one of the InvestingPro Tips.
The company’s stock exhibits low price volatility, another InvestingPro Tip, which may appeal to investors seeking stability in their portfolios. This characteristic could be particularly reassuring during the period of regulatory review and potential market entry for new drugs like odronextamab.
On the financial metrics front, Regeneron’s P/E Ratio stands at 29.01, reflecting investor expectations of future earnings growth, while the adjusted P/E Ratio for the last twelve months as of Q1 2024 is slightly lower at 26.76. The company’s revenue growth over the last twelve months was 5.9%, indicating a steady increase despite the challenges faced in the biotech sector. Moreover, with an impressive gross profit margin of 51.31% for the same period, Regeneron demonstrates its ability to maintain profitability and operational efficiency.
For investors looking for deeper insights and additional metrics, there are 15 more InvestingPro Tips available at: https://www.investing.com/pro/REGN. These tips provide a comprehensive analysis of Regeneron’s financial health and market potential. Plus, by using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering even more value to those seeking to make informed investment decisions.
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