Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

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.