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

Regeneron Pharmaceuticals Inc. 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.