Regeneron Pipeline Goals To Deal with $220 Billion Therapeutic Alternatives By 2030 – Regeneron Prescribed drugs (NASDAQ:REGN)

Regeneron Prescribed drugs Inc. REGN CEO and founder Leonard Schleifer highlighted the corporate’s product pipeline throughout JPMorgan’s Healthcare Convention on Monday.

EYLEA

• In 2024, EYLEA HD (8 mg) and EYLEA (2 mg) achieved $6 billion in complete annual gross sales and $1.5 billion in fourth-quarter gross sales regardless of rising competitors.
• The corporate utilized for FDA approval of an EYLEA HD pre-filled syringe, with a choice and launch anticipated by mid-2025.
• The FDA is reviewing information for moist age-related macular degeneration and diabetic macular edema, doubtlessly extending EYLEA HD dosing to each 24 weeks. A call (PDUFA date) is anticipated by April 20, 2025.
• A submission for FDA approval of EYLEA HD for four-week dosing and retinal vein occlusion is deliberate for early 2025 to increase remedy choices.

Libtayo

• Libtayo (cemiplimab) exceeded $1 billion in gross sales for 2024 and stays foundational to Regeneron’s oncology portfolio.
• Regeneron launched outcomes from the Section 3 C-POST trial, which demonstrated that adjuvant remedy with Libtayo led to a statistically vital and clinically significant enchancment within the major endpoint of disease-free survival in sufferers with high-risk cutaneous squamous cell carcinoma after surgical procedure.
• On the first prespecified interim evaluation, Libtayo demonstrated a 68% discount within the danger of illness recurrence or loss of life in comparison with placebo.

Dupixent

• Dupixent (dupilumab) is now used to deal with over one million sufferers globally. The current approval and launch in power obstructive pulmonary illness (COPD) have had a profitable begin, with protection secured from the highest industrial and Medicare payers. Dupixent is now well-positioned to deal with roughly 300,000 sufferers within the U.S.
• Within the third quarter of 2024, Dupixent’s world internet gross sales reached $3.8 billion (+23% YoY), annualizing over $15 billion.

Regeneron’s complete addressable industrial market is anticipated to exceed $220 billion by 2030. Some near-term highlights embrace:

• Itepekimab (IL-33) for COPD: Outcomes are anticipated from the Section 3 AERIFY examine within the second half of 2025, with a possible BLA submission to comply with.
• Fianlimab (LAG3) for melanoma: Combining fianlimab and Libtayo in Section 3 trial. Information is anticipated within the second half of 2025
• Linvoseltamab (BCMAxCD3) for a number of myeloma: A BLA has been resubmitted following the decision of third-party manufacturing points, with launch anticipated in mid-2025.
• Odronextamab (CD20xCD3) for lymphoma: Enrollment is underway for a confirmatory examine to help resubmission of the BLA for FL to the FDA within the first quarter of 2025.
• Issue XI for anticoagulation: Two Issue XI antibodies, REGN7508 (catalytic area) and REGN9933 (A2 area), will advance to pivotal trials in 2025.
• A number of approaches to weight problems: Regeneron is finding out numerous combos with GLP-based therapies. A Section 2 examine of trevogrumab and semaglutide with and with out garetosmab is now absolutely enrolled and a Section 2 examine testing combos of tirzepatide and mibavademab is ongoing, with preliminary information anticipated from each within the second half of 2025.
• BCMAxCD3/Dupixent in extreme allergy: Combining linvoseltamab and Dupixent can doubtlessly get rid of immunoglobulin E (IgE), the important thing driver of allergic reactions, and thus doubtlessly reverse extreme allergic reactions. A trial in sufferers with extreme meals allergic reactions is ongoing, with preliminary medical information exhibiting a profound discount of IgE within the first affected person handled.
• C5 Combo (pozelimab and cemdisiran) in complement-mediated illnesses: Section 3 information for generalized myasthenia gravis anticipated within the second half of 2025. Section 3 information from paroxysmal nocturnal hemoglobinuria anticipated in 2026+ and geographic atrophy, a Section 3 trial in a complicated type of dry AMD is underway.

Value Motion: Regeneron inventory is down 1.23% at $708.05 eventually examine Tuesday.

Learn Subsequent: