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, Inc. (REGN) announced a three-month extension by the FDA for the review of its Biologics License Application for REGEN-COV (casirivimab and imdevimab) aimed at treating COVID-19. This extension, set for July 13, 2022, follows the submission of new data related to pre-exposure prophylactic use. Currently, REGEN-COV is not authorized in any U.S. regions due to variant susceptibility. Regeneron is advancing next-generation antibodies in clinical trials and remains committed to addressing the COVID-19 pandemic.
Regeneron Pharmaceuticals and Sanofi have announced that the European Commission expanded the marketing authorization for Dupixent (dupilumab) to include children aged 6 to 11 with severe asthma characterized by type 2 inflammation. Supported by Phase 3 trial data, Dupixent significantly reduced severe asthma attacks by up to 65% compared to placebo, improved lung function, and quality of life. The treatment also reduced reliance on systemic corticosteroids by 66%. The approval highlights Dupixent's established safety profile and its commitment to addressing severe asthma in pediatric patients.
Regeneron Pharmaceuticals (NASDAQ: REGN) will announce its first quarter 2022 financial results on May 4, 2022, before U.S. markets open. A conference call will follow at 8:30 AM ET, accessible via webcast on the company's website. Participants must register in advance to join by phone, receiving a confirmation email with call details. Regeneron focuses on innovative medicines for serious diseases, leveraging proprietary technologies like VelociSuite® and genetic sequencing efforts through the Regeneron Genetics Center.
Regeneron Pharmaceuticals announces that the FDA has accepted for Priority Review its sBLA for Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in patients aged 12 and older. If approved, Dupixent will be the first FDA-approved treatment for EoE in the U.S. Currently, there are around 160,000 patients in the U.S. with EoE, with about 48,000 not responding to existing therapies. The FDA's decision is expected by August 3, 2022. The sBLA is backed by Phase 3 trial data showing Dupixent's efficacy in easing EoE symptoms.
Regeneron and Sanofi announced positive results from the Phase 3 PRIME2 trial for Dupixent (dupilumab), showing significant effectiveness in treating prurigo nodularis. At 12 weeks, 37% of patients on Dupixent experienced meaningful itch reduction, compared to 22% on placebo. By 24 weeks, this increased to 58% vs 20%. Dupixent also improved skin clarity in 45% of patients. Regulatory filings for Dupixent's approval in prurigo nodularis are planned for 2022. Safety results were consistent with its existing profile, although some adverse events were reported.
Regeneron Pharmaceuticals (NASDAQ: REGN) and the Society for Science celebrated the winners of the 2022 Regeneron Science Talent Search, awarding over $1.8 million to students for their innovative research. Christine Ye won the top prize of $250,000 for her work on gravitational waves from neutron star-black hole collisions. The competition, held in person for the first time since 2019, recognized 40 finalists for their exceptional scientific projects aimed at addressing global challenges. In total, Regeneron awarded $3.1 million across various prizes and scholarships.
On February 28, 2022, Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from a Phase 1 clinical trial of NTLA-2001 for treating transthyretin amyloidosis (ATTR). The study demonstrated a mean serum TTR reduction of 93% at the highest dose (1.0 mg/kg) by day 28, with durable reductions lasting between two to twelve months. The treatment was generally well tolerated, with mild adverse effects reported. The companies plan to advance the therapy into a dose-expansion cohort in Q1 2022, marking a significant step in CRISPR-based genomic medicine.
Regeneron and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab) 300 mg weekly in treating eosinophilic esophagitis (EoE), a chronic inflammatory disease. The trial showed a 64% reduction in disease symptoms after 24 weeks compared to placebo, with 59% of Dupixent patients achieving histological remission. The safety profile was consistent with previous studies. Regulatory filings are expected in 2022. EoE affects around 160,000 patients in the U.S., highlighting the potential market for Dupixent in this indication.
Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab) in treating chronic spontaneous urticaria (CSU) in biologic-naïve patients. The trial showed that Dupixent significantly reduced itch and urticaria activity scores at 24 weeks compared to standard antihistamine treatment. Key findings included a 63% reduction in itch severity and a 65% reduction in urticaria activity. The safety profile of Dupixent remained consistent, with adverse events rates comparable to placebo. Dupixent's potential for treating CSU is still under clinical evaluation.
Regeneron and Sanofi announced the termination of a Phase 3 trial for Dupixent in patients with chronic spontaneous urticaria (CSU) due to failure to achieve statistical significance despite observed improvements in key endpoints. The trial was halted based on an interim analysis indicating futility. However, a previous Phase 3 trial showed positive results in biologic-naïve patients, indicating Dupixent significantly reduced itch and hives. Both companies remain committed to developing Dupixent for CSU and are evaluating next steps following this setback.