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 Japan's Ministry of Health, Labour and Welfare has approved Dupixent® (dupilumab) for treating chronic obstructive pulmonary disease (COPD) in adults with inadequately controlled disease. This marks the first biologic medicine approved for COPD in Japan and represents the first new treatment approach in over a decade.
The approval was based on the BOREAS Phase 3 trial results, where Dupixent demonstrated significant reduction in exacerbations and improved lung function compared to placebo when added to maximum standard-of-care inhaled therapy. The most common adverse event reported was injection site reaction.
This approval adds to Dupixent's existing Japanese approvals for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and chronic spontaneous urticaria. The treatment is now approved for COPD in over 45 countries worldwide.
Regeneron Pharmaceuticals (NASDAQ: REGN) has scheduled the release of its first quarter 2025 financial and operating results for Tuesday, April 29, 2025, before U.S. market opening. The company will host a conference call and webcast at 8:30 AM Eastern Time on the same day.
Investors can access the conference call through a webcast on Regeneron's investor relations website. Telephone participants must pre-register to receive dial-in details and access credentials. A replay and transcript will be available on the company's website for a minimum of 30 days following the call.
Regeneron Pharmaceuticals and Society for Science announced the winners of the 2025 Regeneron Science Talent Search, awarding over $1.8 million to talented high school seniors. Matteo Paz, 18, from Pasadena, California, secured the top prize of $250,000 for developing machine-learning algorithms that analyzed NEOWISE infrared sky data, identifying 1.5 million new potential celestial objects.
The second-place prize of $175,000 went to Ava Grace Cummings for research on STAC3 disorder treatment, while Owen Jianwen Zhang earned third place and $150,000 for solving a complex mathematical problem. The competition, now in its 84th year, recognized 40 finalists for their innovative STEM research at the National Building Museum in Washington, D.C.
The total awards from Regeneron amounted to $3.1 million, including $2,000 to each top scholar and their school. Winners join an elite alumni network that includes Nobel Prize winners, National Medal of Science recipients, and MacArthur Fellows.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the winners of the 2025 Regeneron Science Talent Search, awarding over $1.8 million to exceptional high school seniors for innovative STEM research. Matteo Paz, 18, from Pasadena, won the $250,000 top prize for developing machine-learning algorithms analyzing NEOWISE infrared data, identifying 1.5 million new potential space objects.
The competition's second place ($175,000) went to Ava Grace Cummings for research on STAC3 disorder treatment, while Owen Jianwen Zhang secured third place ($150,000) for solving a complex mathematical problem. Seven other finalists received awards ranging from $40,000 to $100,000 for research in areas including mosquito control, voter ID laws, and drug-resistant fungal infections.
The 84-year-old competition, America's oldest and most prestigious science and math contest, awarded a total of $3.1 million, including $2,000 to each top scholar and their school.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi presented positive results from the pivotal ADEPT Phase 2/3 trial for Dupixent® (dupilumab) in treating moderate-to-severe bullous pemphigoid (BP). The trial, involving 106 adults, demonstrated significant advantages over placebo:
Key findings at 36 weeks showed:
- 20% achieved sustained disease remission vs 4% for placebo
- 40% achieved ≥90% reduction in disease severity vs 10%
- 40% experienced meaningful itch reduction vs 11%
- 1,678mg reduction in corticosteroid exposure and 54% lower risk of rescue medication use
The FDA has accepted Priority Review for Dupixent in BP treatment, with a decision expected by June 20, 2025. The drug received Orphan Drug Designation for BP, which affects fewer than 200,000 people in the U.S. Regulatory submissions are also under review in the European Union.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a positive recommendation from the European Medicines Agency's CHMP for conditional marketing authorization of linvoseltamab, a treatment for relapsed and refractory multiple myeloma. The recommendation applies to adult patients who have undergone at least three prior therapies and shown disease progression on their last treatment.
The recommendation is based on data from the LINKER-MM1 trial. Additionally, the FDA has accepted the Biologics License Application for linvoseltamab review, with a target decision date of July 10, 2025. The European Commission's final decision is expected in the coming months. The drug remains investigational and awaits regulatory approval.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for odronextamab in treating relapsed/refractory follicular lymphoma. The FDA decision is expected by July 30, 2025.
The resubmission follows meeting the FDA-mandated enrollment target for the Phase 3 OLYMPIA-1 confirmatory trial. Phase 1 and 2 trials showed promising results with an 80% overall response rate (n=103) and 74% complete response rate (n=95). However, serious adverse events occurred in 67% of patients, including cytokine release syndrome, COVID-19, and pneumonia.
The drug is already approved as Ordspono™ in the European Union for treating relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Regeneron Pharmaceuticals (NASDAQ: REGN) reported promising results from the Phase 1/2 CHORD trial of DB-OTO, a gene therapy for profound genetic hearing loss caused by otoferlin gene variants. Of 12 treated children, 10 out of 11 with post-treatment assessments showed notable hearing improvements.
The first child treated, at 10 months old, showed near-normal hearing levels across key speech frequencies at 48 weeks, with continued progress at 72 weeks, including the ability to identify words at conversational levels. Among five participants with 24-week assessments, three achieved 'nearly normal' or normal hearing levels.
The treatment was well-tolerated across all participants, with only temporary post-surgical vestibular effects in five patients that resolved within 6 days. DB-OTO has received multiple FDA designations including Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy, as well as EMA Orphan Drug Designation.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its participation in two major healthcare investor conferences in March 2025. The company will present at the TD Cowen 45th Annual Health Care Conference on March 4 at 11:50 a.m. ET, and the Leerink Partners 2025 Global Healthcare Conference on March 11 at 8:00 a.m. ET.
Both presentations will be accessible via webcast through Regeneron's investor relations website. The company will maintain archives of the webcasts and transcripts for a minimum of 30 days on their corporate website's 'Investors & Media' section.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for linvoseltamab, targeting the treatment of adult patients with relapsed/refractory multiple myeloma. The treatment is specifically for patients who have undergone at least four prior therapy lines or those with three prior lines who are refractory to their last treatment.
The FDA's decision is expected by July 10, 2025. The resubmission follows the resolution of third-party fill/finish manufacturing issues, which was previously the only approvability concern. The application is supported by data from the LINKER-MM1 trial and is currently also under review by the European Medicines Agency (EMA) for the same patient population.
FAQ
What is the current stock price of Regeneron Pharmaceuticals (REGN)?
What is the market cap of Regeneron Pharmaceuticals (REGN)?
