Regeneron Pipeline Aims To Address $220 Billion Therapeutic Opportunities By 2030

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) CEO and founder Leonard Schleifer highlighted the company’s product pipeline during JPMorgan’s Healthcare Conference on Monday.

EYLEA

• In 2024, EYLEA HD (8 mg) and EYLEA (2 mg) achieved $6 billion in total annual sales and $1.5 billion in fourth-quarter sales despite growing competition.
• The company applied for FDA approval of an EYLEA HD pre-filled syringe, with a decision and launch expected by mid-2025.
• The FDA is reviewing data for wet age-related macular degeneration and diabetic macular edema, potentially extending EYLEA HD dosing to every 24 weeks. A decision (PDUFA date) is expected by April 20, 2025.
• A submission for FDA approval of EYLEA HD for four-week dosing and retinal vein occlusion is planned for early 2025 to expand treatment options.

Libtayo

• Libtayo (cemiplimab) exceeded $1 billion in sales for 2024 and remains foundational to Regeneron’s oncology portfolio.
• Regeneron released results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment with Libtayo led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival in patients with high-risk cutaneous squamous cell carcinoma after surgery.
• At the first prespecified interim analysis, Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo.

Dupixent

• Dupixent (dupilumab) is now used to treat over a million patients globally. The recent approval and launch in chronic obstructive pulmonary disease (COPD) have had a successful start, with coverage secured from the top commercial and Medicare payers. Dupixent is now well-positioned to address approximately 300,000 patients in the U.S.
• In the third quarter of 2024, Dupixent’s global net sales reached $3.8 billion (+23% YoY), annualizing over $15 billion.

Regeneron’s total addressable commercial market is expected to exceed $220 billion by 2030. Some near-term highlights include:

• Itepekimab (IL-33) for COPD: Results are expected from the Phase 3 AERIFY study in the second half of 2025, with a potential BLA submission to follow.
• Fianlimab (LAG3) for melanoma: Combining fianlimab and Libtayo in Phase 3 trial. Data is expected in the second half of 2025
• Linvoseltamab (BCMAxCD3) for multiple myeloma: A BLA has been resubmitted following the resolution of third-party manufacturing issues, with launch anticipated in mid-2025.
• Odronextamab (CD20xCD3) for lymphoma: Enrollment is underway for a confirmatory study to support resubmission of the BLA for FL to the FDA in the first quarter of 2025.
• Factor XI for anticoagulation: Two Factor XI antibodies, REGN7508 (catalytic domain) and REGN9933 (A2 domain), will advance to pivotal trials in 2025.
• Multiple approaches to obesity: Regeneron is studying various combinations with GLP-based therapies. A Phase 2 study of trevogrumab and semaglutide with and without garetosmab is now fully enrolled and a Phase 2 study testing combinations of tirzepatide and mibavademab is ongoing, with initial data expected from both in the second half of 2025.
• BCMAxCD3/Dupixent in severe allergy: Combining linvoseltamab and Dupixent can potentially eliminate immunoglobulin E (IgE), the key driver of allergic reactions, and thus potentially reverse severe allergies. A trial in patients with severe food allergies is ongoing, with initial clinical data showing a profound reduction of IgE in the first patient treated.
• C5 Combo (pozelimab and cemdisiran) in complement-mediated diseases: Phase 3 data for generalized myasthenia gravis expected in the second half of 2025. Phase 3 data from paroxysmal nocturnal hemoglobinuria expected in 2026+ and geographic atrophy, a Phase 3 trial in an advanced form of dry AMD is underway.

Price Action: Regeneron stock is down 1.23% at $708.05 at last check Tuesday.

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