Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron reported Q1 2025 financial results with total revenues of $3.0 billion, showing mixed performance across its product portfolio. Dupixent global sales grew 19% to $3.67 billion, while EYLEA HD U.S. sales increased 54% to $307 million.

Key highlights include:

• FDA approval of Dupixent for chronic spontaneous urticaria
• Japanese approval for Dupixent in COPD treatment
• EU approval of Lynozyfic for multiple myeloma
• Priority review status for EYLEA HD in retinal vein occlusion

The company announced over $7 billion in planned investments for New York and North Carolina infrastructure. Financial metrics showed GAAP diluted EPS of $7.27 and non-GAAP EPS of $8.22. While total EYLEA franchise sales declined 26% to $1.04 billion, the company maintains a robust pipeline with approximately 45 product candidates in clinical development.

Regeneron Pharmaceuticals (NASDAQ: REGN) has received conditional marketing approval from the European Commission for Lynozyfic™ (linvoseltamab), a novel bispecific antibody for treating relapsed/refractory multiple myeloma. The approval targets adult patients who have undergone at least three prior therapies and shown disease progression.

The LINKER-MM1 trial (n=117) demonstrated strong efficacy with a 71% objective response rate and 50% of patients achieving complete response or better. The median duration of response was 29 months. Lynozyfic features a unique response-adapted dosing schedule allowing administration every four weeks if specific response criteria are met after 24 weeks of therapy.

The most common adverse reactions included musculoskeletal pain (52%), cytokine release syndrome (46%), and neutropenia (43%). A U.S. FDA decision is expected by July 10, 2025.

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.