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 announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for odronextamab to treat relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The recommendation is based on data from Phase 1 and Phase 2 trials showing robust and durable response rates. The European Commission is expected to make a final decision in the coming months. FL and DLBCL are common subtypes of B-cell non-Hodgkin lymphoma, with significant relapse rates after initial treatments. In Europe, approximately 15,000 FL and 31,000 DLBCL cases are diagnosed annually. The most common serious adverse reactions reported were cytokine release syndrome, pneumonia, COVID-19, and pyrexia. Odronextamab has not yet been approved by any regulatory authority and is still under clinical development.
Regeneron Pharmaceuticals announced it will release its Q2 2024 financial and operating results on August 1, 2024, before U.S. markets open. The company will hold a conference call and webcast at 8:30 AM ET on the same day. Investors can access the webcast via Regeneron's investor relations page. For telephone participation, pre-registration is required. A replay and transcript of the call will be available on the company's website for a minimum of 30 days.
Regeneron Pharmaceuticals and Sanofi have announced positive Phase 3 trial results for Dupixent (dupilumab) in treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years. The study, published in the New England Journal of Medicine, showed that a higher proportion of patients receiving weight-tiered higher dose Dupixent achieved significant improvements in EoE symptoms compared to placebo at week 16. These improvements were sustained for up to one year. The data supported the FDA's approval of Dupixent for this age group and are under review by the European Medicines Agency. The trial also found that Dupixent led to improvements in body weight for age percentile and had a safety profile consistent with its use in older patients.
Regeneron Pharmaceuticals announced 14-month follow-up data from the LINKER-MM1 trial on linvoseltamab for relapsed/refractory multiple myeloma. The trial showed a 71% overall response rate (ORR) and 50% complete response (CR) or better. Median duration of response (DoR) was 29 months, and median overall survival (OS) was 31 months. Safety data were consistent with previous results, with cytokine release syndrome (CRS) in 46% of patients as the most common adverse event. Linvoseltamab showed better outcomes compared to real-world standard care. The U.S. FDA has given it Fast Track Designation and Priority Review, with a decision expected by August 22, 2024. The drug is also under review by the European Medicines Association and is in a Phase 3 confirmatory trial.
Regeneron Pharmaceuticals and Sanofi announced FDA approval of Kevzara® (sarilumab) for treating active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing 63 kg or more.
This expands Kevzara’s use beyond adult chronic inflammatory conditions like rheumatoid arthritis and polymyalgia rheumatica. The approval is based on comprehensive studies and pharmacokinetic data from adults and pediatric patients.
Common adverse reactions include nasopharyngitis, neutropenia, and upper respiratory tract infection. KevzaraConnect® provides support services to help patients access the treatment.
Regeneron Pharmaceuticals and Sanofi announced that Dupixent (dupilumab) has been recommended for EU approval by the CHMP as an add-on maintenance treatment for adults with uncontrolled COPD marked by raised blood eosinophils. This recommendation is based on Phase 3 trials (BOREAS and NOTUS), where Dupixent showed a significant reduction in annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo and improved lung function and quality of life over 52 weeks. If approved, Dupixent would be the first targeted therapy for COPD in the EU and the first new treatment approach for COPD in over a decade. The European Commission's final decision is expected within months.
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has extended the target action date for the priority review of Dupixent (dupilumab) by three months to September 27, 2024. This extension follows the submission of additional efficacy analyses requested by the FDA for the BOREAS and NOTUS pivotal trials. The FDA has no concerns about the approvability of Dupixent for treating uncontrolled COPD with type 2 inflammation. The companies are optimistic that this supplemental Biologics License Application (sBLA) will be approved. Additionally, reviews are ongoing with regulatory authorities in the EU and China. The EMA has already recommended approval in the EU. However, the safety and efficacy of Dupixent in COPD have not been fully evaluated by any regulatory authority.
Biohaven has dosed its first patient in a Phase 1/2 study of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC) targeting advanced or metastatic epithelial tumors. BHV-1510 has shown promising preclinical results, including superior efficacy and a broader therapeutic margin compared to other Trop-2 ADCs. The study will evaluate the drug as a monotherapy and in combination with Regeneron's anti-PD-1 therapy, Libtayo®. Biohaven's proprietary ADC technology and partnership with Regeneron aim to advance treatment options in oncology, particularly for cancers with significant unmet medical needs.
The multicenter, open-label trial will have a dose-escalation phase followed by a multicohort expansion phase. Preclinical data suggests BHV-1510 could offer a better safety profile, including no lung toxicity, and improved clinical efficacy. The partnership with Regeneron will see Biohaven sponsor and fund the trial, while Regeneron supplies Libtayo. This initiative represents a key step in Biohaven's broader oncology strategy.
Regeneron Pharmaceuticals announced promising results from a Phase 1/2 trial of their bispecific antibody REGN7075 combined with Libtayo in advanced solid tumors, particularly microsatellite stable colorectal cancer (MSS CRC). The trial showed a 6% overall response rate (ORR) and 29% disease control rate (DCR) among 51 MSS CRC patients. Positive results were noted, especially in patients without liver metastases. The combination therapy displayed an acceptable safety profile, with no dose-limiting toxicities or treatment-related deaths. Results will be presented at the ASCO 2024 Annual Meeting.
Regeneron Pharmaceuticals and Sanofi have presented late-breaking data from the NOTUS Phase 3 trial, confirming positive results from the BOREAS trial. The data, presented at the 2024 American Thoracic Society International Conference and published in the New England Journal of Medicine, show Dupixent® (dupilumab) significantly reduced exacerbations by 34% and improved lung function in patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation. These results position Dupixent as a potential first-ever targeted therapy for COPD. Regulatory reviews are ongoing, with a U.S. FDA action date set for June 27, 2024.