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Regeneron Pharmaceuticals Inc. (symbol: REGN) is a prominent American biotechnology company headquartered in Westchester County, New York, since its founding in 1988. The core mission of Regeneron is to discover, develop, and commercialize innovative products targeting a range of serious medical conditions. With a diverse portfolio, Regeneron focuses on therapies for eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.
Among its marketed products, Eylea stands out as a treatment for wet age-related macular degeneration and other eye diseases. Praluent is designed to lower LDL cholesterol levels, while Dupixent addresses multiple immunological conditions. In the oncology sector, Libtayo is a key therapy, and Kevzara targets rheumatoid arthritis.
The company is also heavily invested in the development of monoclonal and bispecific antibodies, often in collaboration with Sanofi and other partners. These initiatives include cutting-edge technologies such as RNA interference (RNAi) with Alnylam and CRISPR-based gene editing with Intellia.
Regeneron's recent progress includes significant advancements in its clinical-stage pipeline, which comprises over 35 product candidates. The company's financial health remains robust, supported by strong revenue streams from collaboration with Sanofi and a strategic $3.0 billion share repurchase program authorized by the board.
Latest updates highlight the company's ongoing efforts in gene therapy, particularly in treating genetic deafness and solid tumors. Regeneron's commitment to pioneering genetic medicine and leveraging data insights from the Regeneron Genetics Center® positions it as a leader in the biopharmaceutical industry.
For more information, visit Regeneron Pharmaceuticals.
Regeneron Pharmaceuticals and Sanofi announced that the European Commission has approved Dupixent (dupilumab) as the first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils. This approval is based on two Phase 3 trials, BOREAS and NOTUS, which showed significant reductions in COPD exacerbations and improvements in lung function and quality of life. The trials demonstrated a 30% and 34% reduction in annual exacerbation rates and notable lung function improvements.
This marks the first new treatment for COPD in over a decade, offering a novel option for approximately 220,000 adults in the EU. Dupixent's approval also represents its sixth indication in the EU and seventh globally. Further regulatory submissions are under review in other countries, including the U.S., China, and Japan.
The efficacy results showed improvements in FEV1 by 160 mL and 139 mL at 12 weeks, compared to placebo improvements of 77 mL and 57 mL. Safety results were consistent with known profiles, with common side effects including injection site reactions and conjunctivitis.
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.
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