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 (NASDAQ: REGN) and Sanofi announced that the EMA's CHMP has issued positive opinions for Libtayo (cemiplimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) and for advanced basal cell carcinoma (BCC). Libtayo is recommended for NSCLC patients with ≥50% PD-L1 expression and without specific genetic aberrations. The recommendation for BCC comes after patients have progressed on or are intolerant to hedgehog pathway inhibitors. The European Commission will decide on these applications soon.
Regeneron Pharmaceuticals (REGN) announced Michelle Hua, 16, as the top prize winner at the 2021 Regeneron International Science and Engineering Fair, receiving a $75,000 award for her innovative AI algorithm in human action recognition. This year marked the event's first virtual format, showcasing over 1,800 young scientists from 49 states and 64 countries. Over $5 million in total prizes were awarded. The initiative aims to inspire young STEM leaders, highlighting the importance of scientific inquiry, especially during the COVID-19 pandemic.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive clinical data for the combination of fianlimab (LAG-3 inhibitor) and Libtayo (cemiplimab) in advanced melanoma, achieving a 64% objective response rate in PD-1 inhibitor naïve patients. Upcoming presentations at the ASCO Annual Meeting from June 4-8 will cover various cancers, including lung and skin cancers, focusing on Libtayo's impact on quality of life. An investor webcast is scheduled for June 7 to discuss further updates on its oncology portfolio.
Regeneron Pharmaceuticals reported promising results from its Phase 3 trial of REGEN-COV, demonstrating significant efficacy in treating high-risk COVID-19 outpatients. Patients receiving REGEN-COV experienced a 70-71% reduced risk of hospitalization or death and a 4-day shorter symptom duration compared to placebo. The U.S. FDA is reviewing a request to authorize a lower 1,200 mg dose. The trial involved 4,567 participants, highlighting the treatment's potential for individuals with conditions like asthma and obesity. Safety assessments showed a low rate of serious adverse events.
Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab), demonstrating significant efficacy in improving lung function and reducing severe asthma attacks in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial revealed a 65% reduction in asthma attacks and rapid improvements in lung function within two weeks. FDA approval for this indication is expected by October 21, 2021. The study highlights Dupixent's potential as a best-in-class treatment, targeting type 2 inflammation, a common cause of asthma in this population.
Regeneron and Sanofi announced positive Phase 3 trial results for Libtayo (cemiplimab) in advanced cervical cancer, demonstrating a 31% reduction in the risk of death compared to chemotherapy. Significant improvements were observed in overall survival, progression-free survival, and objective response rate. The study included 304 patients in each treatment group, revealing a median response duration of 16 months for Libtayo versus 7 months for chemotherapy. The findings support Libtayo as a potential second-line treatment, with regulatory submissions expected in 2021.
Regeneron Pharmaceuticals reported a strong first quarter of 2021 with revenues of $2.53 billion, up 38% from 2020. Net sales of EYLEA rose 15% to $1.35 billion, and Dupixent global net sales increased 48% to $1.26 billion. GAAP diluted EPS reached $10.09, a significant increase compared to $5.43 in Q1 2020. The company received three FDA approvals and reported positive Phase 3 results for REGEN-COV in COVID-19 treatment and prevention. Strong growth is anticipated in EYLEA and Dupixent, with a solid pipeline of approximately 30 product candidates in clinical development.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 3 results for two of its medicines at the upcoming 2021 ATS International Conference, scheduled for May 17. The studies include REGEN-COV™, an investigational COVID-19 treatment for high-risk outpatients, and Dupixent®, for children aged 6 and older with uncontrolled asthma. These findings underscore Regeneron's commitment to advancing healthcare solutions. Presentations also cover Dupixent's impact on corticosteroid use in adults and data on chronic rhinosinusitis treatment.
Summary not available.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced nearly 30 presentations on Dupixent at AAD VMX 2021 and ESPD 2021. The data highlights Dupixent's effectiveness in providing rapid itch relief and improving disease severity in patients as young as 6 years old with moderate-to-severe atopic dermatitis. Clinical trials showed long-term efficacy and a favorable safety profile, with lower infection rates compared to placebo. Key findings include significant improvements in quality of life and disease measures across various age groups, supporting Dupixent's essential role in managing atopic dermatitis.