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 (REGN) announced 27 upcoming presentations at ARVO 2025, including eight oral presentations focusing on EYLEA HD® (aflibercept) Injection 8 mg for retinal diseases. The presentations will showcase initial real-world data from nearly 40,000 patients, demonstrating improved vision and longer dosing intervals in clinical practice.
Key highlights include analyses of real-world experiences with EYLEA HD in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) patients, both treatment-naive and those switching from other therapies. The presentations will also feature network meta-analyses comparing EYLEA HD with faricimab, and economic benefit modeling over three years.
The most common adverse reactions (≥3%) reported include cataract, conjunctival hemorrhage, increased intraocular pressure, ocular discomfort, blurred vision, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced a major expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies. The 10-year partnership, valued at over $3 billion, will nearly double Regeneron's U.S. large-scale manufacturing capacity using Fujifilm's Holly Springs, North Carolina facility.
The company is also investing heavily in its New York operations, with a $3.6 billion expansion of its Tarrytown campus that will create 1,000 full-time, high-skill jobs. Additional developments include a new fill/finish manufacturing facility in Rensselaer and acquisition of a 1+ million-square-foot property in Saratoga Springs for production support and potential manufacturing.
Over the past five years, Regeneron has added more than 7,000 jobs, primarily in R&D and manufacturing within the United States. The company's total planned investments in New York and North Carolina infrastructure and manufacturing are expected to exceed $7 billion.
FUJIFILM Diosynth Biotechnologies and Regeneron (NASDAQ: REGN) have signed a significant 10-year manufacturing supply agreement valued at over $3 billion. The partnership will provide U.S.-based production of Regeneron's biologic medicines at FUJIFILM's new large-scale facility in Holly Springs, North Carolina.
The facility will begin operations in 2025, with additional capacity coming online in 2025, 2026, and beyond as part of FUJIFILM's $7 billion expansion projects across Europe and the United States. The Holly Springs site is part of FUJIFILM's kojoX™ interconnected manufacturing network, featuring standardized equipment and processes globally.
FUJIFILM has invested approximately $4 billion in U.S. biopharmaceutical manufacturing sites and has already created 500 new positions toward its goal of 1,400 new jobs in North Carolina by 2031.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its participation in four major healthcare investor conferences in May and June 2025:
- BofA Securities 2025 Health Care Conference on May 13 at 1:00 p.m. ET
- RBC Capital Markets Global Healthcare Conference on May 20 at 11:00 a.m. ET
- Bernstein 41st Annual Strategic Decisions Conference on May 28 at 11:00 a.m. ET
- Goldman Sachs 46th Annual Global Healthcare Conference on June 9 at 10:40 a.m. ET
All sessions will be accessible through webcasts on Regeneron's investor relations website, with replays and transcripts available for at least 30 days after the events.
Regeneron Pharmaceuticals (NASDAQ: REGN) has received a Complete Response Letter (CRL) from the FDA regarding their supplemental Biologics License Application for EYLEA HD® (aflibercept) Injection 8 mg. The application sought to extend dosing intervals up to 24 weeks across all approved indications.
The FDA did not identify any safety or efficacy concerns with EYLEA HD's currently approved indications and dosing regimens but rejected the proposal for additional extended dosing intervals beyond the current maximum of 16 weeks. EYLEA HD maintains its existing approval for dosing intervals of 8-16 weeks for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced FDA approval of Dupixent® (dupilumab) for treating chronic spontaneous urticaria (CSU) in adults and adolescents aged 12+ who remain symptomatic despite antihistamine treatment. This marks the first new targeted therapy for CSU in over a decade.
The approval is supported by two Phase 3 trials (Study A with 136 patients and Study C with 148 patients) that demonstrated significant reductions in itch severity and urticaria activity compared to placebo at 24 weeks. An additional Study B (108 patients) provided safety data for patients who were inadequate responders to anti-IgE therapy.
This represents Dupixent's seventh FDA-approved indication for conditions driven by type 2 inflammation. The treatment will target over 300,000 U.S. adults and adolescents with CSU who remain symptomatic despite antihistamine treatment. The most common adverse event was injection site reactions.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced FDA's acceptance of Priority Review for EYLEA HD® (aflibercept) Injection 8 mg's supplemental Biologics License Application (sBLA). The application covers two key areas: treating macular edema following retinal vein occlusion (RVO) and enabling monthly dosing across approved indications.
The FDA target action date is set for August 19, 2025. If approved, EYLEA HD would pioneer 8-week dosing for RVO treatment after initial monthly doses, reducing injection frequency by half compared to other anti-VEGF therapies.
The Phase 3 QUASAR trial demonstrated EYLEA HD's non-inferior visual acuity gains at 36 weeks compared to EYLEA 2 mg monthly dosing. Safety profiles remained consistent with previous trials, with increased ocular pressure (5% vs 1.7%) being the main treatment-emergent adverse event.
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.
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