Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency's CHMP for its COVID-19 antibody cocktail, REGEN-COV, which can treat high-risk patients without supplemental oxygen. The endorsement allows EU member states to use this opinion for national decisions prior to market authorization. Roche, Regeneron's collaboration partner, is responsible for distribution outside the U.S. and has started distribution in the EU. Data indicates a significant reduction in virus levels and fewer medical visits for treated patients. This therapy aims to support global COVID-19 management.
Regeneron Pharmaceuticals announced changes to its Phase 3 trial for REGEN-COV™ (casirivimab with imdevimab) in non-hospitalized COVID-19 patients. Following the Independent Data Monitoring Committee's recommendation, enrollment in the placebo group will be halted due to demonstrated clinical efficacy in reducing hospitalization and death rates with the 1,200 mg and 2,400 mg doses. Continued enrollment will focus on these treatment groups, with detailed results expected in March 2021. REGEN-COV is currently available in the U.S. under Emergency Use Authorization.
Regeneron and Sanofi announced FDA approval for Libtayo® (cemiplimab-rwlc) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression. This approval, based on a pivotal trial with 710 patients, demonstrated that Libtayo improved overall survival (OS) by 32% over chemotherapy, with a median OS of 22 months versus 14 months. The trial also showed a notable crossover rate of over 70% to Libtayo post-chemotherapy. This is the third FDA approval for Libtayo, which is also effective in basal cell carcinoma and squamous cell carcinoma.
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Regeneron Pharmaceuticals and Sanofi announced that Libtayo® (cemiplimab) demonstrated superior overall survival compared to chemotherapy in advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The Lancet published these pivotal trial results, which support regulatory submissions in the U.S. and EU. The FDA has granted a Priority Review with a target action date of February 28, 2021. Libtayo reduced the risk of death by 32% overall and 43% in high PD-L1 expressers. Safety profiles were consistent, with higher immune-mediated adverse events in the Libtayo group.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the U.S. Court of Appeals upheld a previous ruling invalidating Amgen's patent claims on PCSK9 antibodies, benefiting Regeneron's Praluent. This decision confirms that Amgen's patents were overly broad and validates Regeneron's proprietary technology in developing Praluent. This ruling follows a similar decision by the European Patent Office. Regeneron maintains exclusive rights to Praluent in the U.S., while Sanofi holds rights outside the U.S. Praluent is approved in over 60 countries to lower LDL cholesterol and reduce heart attack risks.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA approval of Evkeeza (evinacumab-dgnb) for treating homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older. Evkeeza, the first ANGPTL3 inhibitor approved, reduced LDL-C levels by nearly 50% in a pivotal Phase 3 trial. The average annual cost is projected at $450,000. Regeneron also offers financial support through the myRARE™ program, aiming to ease access for eligible patients. This approval marks a significant milestone for patients suffering from this ultra-rare condition.
Regeneron and Sanofi announced FDA approvals for Libtayo® (cemiplimab-rwlc), the first immunotherapy for advanced basal cell carcinoma (BCC). The treatment received full approval for locally advanced BCC and accelerated approval for metastatic BCC. This marks a pivotal advancement for patients who progress on hedgehog pathway inhibitors. In clinical trials, Libtayo demonstrated a 21% overall response rate in metastatic BCC and 29% in locally advanced BCC. Adverse reactions were reported in 32% of patients, underscoring the need for monitoring during treatment.
Regeneron Pharmaceuticals (REGN) reported a 30% revenue increase to $2.42 billion in Q4 2020, with EYLEA® U.S. net sales at $1.34 billion (+10%) and Dupixent® global sales at $1.17 billion (+56%). GAAP diluted EPS rose 48% to $10.24. The REGEN-COV™ antibody cocktail received FDA Emergency Use Authorization, with a new agreement for 1.25 million doses worth $2.625 billion. The company anticipates continued growth in 2021 through EYLEA, Dupixent, and Libtayo, with several regulatory reviews pending.
Regeneron Pharmaceuticals and Sanofi announced new analyses highlighting the efficacy of Dupixent® (dupilumab) in treating diseases driven by type 2 inflammation, including asthma, atopic dermatitis, eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyposis. The results, to be presented at the AAAAI Virtual Annual Meeting from February 26 to March 1, demonstrate significant improvements in patients' symptoms across multiple studies. Dupixent, a fully-human monoclonal antibody, targets IL-4 and IL-13 signaling, vital in managing type 2 inflammatory diseases.