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) presented new data for odronextamab at the ASH Annual Meeting, highlighting promising results across multiple B-cell lymphoma types. In the OLYMPIA-1 trial's safety lead-in, odronextamab achieved complete responses in all 12 evaluable previously untreated follicular lymphoma patients.
The ELM-1 trial's expansion cohort showed 48% objective response rate in diffuse large B-cell lymphoma patients who progressed after CAR-T therapy, with 32% achieving complete response. The ELM-2 trial demonstrated 77% complete response rate in relapsed/refractory marginal zone lymphoma patients.
Odronextamab is currently approved in the EU as Ordspono™ for certain lymphoma indications, with U.S. regulatory resubmission expected in first half of 2025.
Regeneron Pharmaceuticals announced positive Phase 3 data for their novel combination treatment pozelimab and cemdisiran (poze-cemdi) in treating paroxysmal nocturnal hemoglobinuria (PNH). The exploratory cohort of the ACCESS-1 trial showed superior results compared to standard-of-care ravulizumab.
Key findings showed that 96% of patients achieved adequate LDH control with poze-cemdi, compared to 80% with ravulizumab. Additionally, 93% achieved LDH normalization with poze-cemdi versus 65% with ravulizumab. The treatment demonstrated an 84% decrease in LDH from baseline at week 26.
The safety profile was comparable to approved C5 inhibitors, with treatment-emergent adverse events occurring in 84% of poze-cemdi patients versus 87% for ravulizumab. The combination therapy offers the advantage of four-week subcutaneous delivery with potential for self-administration.
Regeneron Pharmaceuticals will present new data from its hematology pipeline across 23 abstracts at the ASH 2024 Annual Meeting. Key highlights include head-to-head results comparing pozelimab plus cemdisiran versus ravulizumab in paroxysmal nocturnal hemoglobinuria, and initial results for odronextamab in first-line follicular lymphoma. The presentations showcase progress in treating 10 types of blood cancers and disorders through various therapeutic approaches, including CD3 bispecific antibodies, costimulatory bispecific antibodies, and a combination of monoclonal antibody and siRNA. Notable presentations include results from the Phase 3 OLYMPIA-1 trial, ELM-1 and ELM-2 trials in diffuse large B-cell lymphoma, and updates on linvoseltamab in multiple myeloma.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its upcoming participation in two major investor conferences. The company will present at the Jefferies London Healthcare Conference on November 19, 2024, at 11:00 a.m. BST (6:00 a.m. ET), and at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 9:30 a.m. ET.
Both presentations will be accessible via webcast through Regeneron's investor relations website. Recordings and transcripts will remain available for a minimum of 30 days after the events.
Regeneron Pharmaceuticals and Sanofi announced European Commission approval of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years weighing at least 15 kg. The approval is based on Phase 3 trial results showing 68% of children achieved histological disease remission at 16 weeks compared to 3% on placebo. The treatment demonstrated an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline. This makes Dupixent the first and only medicine approved in the EU for treating EoE in young children who are inadequately controlled by conventional therapy.
Regeneron (REGN) reported strong Q3 2024 financial results with an 11% revenue increase to $3.72 billion. Key highlights include Dupixent global sales growth of 23% to $3.82 billion, EYLEA HD and EYLEA U.S. sales up 3% to $1.54 billion, and Libtayo global sales increase of 24% to $289 million. GAAP diluted EPS rose 30% to $11.54, while non-GAAP diluted EPS grew 8% to $12.46. The FDA approved Dupixent as the first biologic therapy for COPD treatment. The company maintains a robust pipeline with approximately 40 product candidates in clinical development.
Regeneron Pharmaceuticals and Sanofi presented positive Phase 3 data for Dupixent in treating chronic spontaneous urticaria (CSU). The LIBERTY-CUPID Study C showed significant improvements in patients receiving Dupixent with antihistamines compared to placebo. Key results at 24 weeks included a 8.64-point reduction in itch severity score and 41% of patients achieving well-controlled disease status. The study involved 151 biologic-naïve patients, with 74 receiving Dupixent and 77 receiving placebo. Safety results aligned with Dupixent's known profile, with 53% experiencing treatment emergent adverse events in both groups. The companies plan to submit for U.S. regulatory approval by year-end.
Regeneron Pharmaceuticals announced positive three-year data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). Key findings include:
- 88% of EYLEA HD patients maintained ≥12-week dosing intervals at week 156
- 48% achieved ≥20-week dosing intervals
- Sustained visual gains and anatomic improvements from year two
- Patients switched from EYLEA® 2 mg to EYLEA HD experienced slower fluid reaccumulation
- 83% of switched patients maintained ≥12-week dosing intervals
The safety profile remained consistent with known EYLEA HD and EYLEA profiles. These results support EYLEA HD's longer duration of action and potential for reduced treatment burden in DME patients.
Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent® (dupilumab) as the first-ever biologic medicine for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. This approval follows recent approvals in the EU and China.
The approval is based on two Phase 3 trials (BOREAS and NOTUS) that showed Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life compared to placebo. Key results include:
- 30-34% reduction in moderate or severe COPD exacerbations
- 68-74mL improvements in post-bronchodilator FEV1
- 51% response in health-related quality of life measure
Dupixent is now indicated for approximately 300,000 adults in the U.S. with this specific COPD phenotype. The FDA evaluated Dupixent under Priority Review, recognizing its potential significant improvements in efficacy or safety for treating serious conditions.
Regeneron Pharmaceuticals and Sanofi announced that China's National Medical Products Administration (NMPA) has approved Dupixent® (dupilumab) for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The approval is based on two Phase 3 trials, BOREAS and NOTUS, which showed Dupixent significantly reduced COPD exacerbations by 30% and 34% respectively, improved lung function, and enhanced quality of life compared to placebo.
COPD is the most prevalent chronic respiratory disease in China, affecting one in four people with COPD worldwide. The approval of Dupixent fills a gap in targeted therapy for COPD patients who remain inadequately controlled even after triple therapy. Dupixent is now approved in four indications across respiratory and dermatological diseases in China, and in more than 30 countries worldwide for COPD treatment.
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