Regeneron Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1988-01-01
- Employees
- 13.4K
- Market Cap
- $132.4B
- Website
- http://www.regeneron.com
- Introduction
Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, George Damis Yancopoulos, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.
Post-approval evidence generation: a shared responsibility for healthcare
A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.
Dupixent Demonstrates Reducing Symptoms of Chronic Spontaneous Urticaria
Dupixent (dupilumab) showed significant potential in treating chronic spontaneous urticaria (CSU) in biologic-naïve patients unresponsive to antihistamines, reducing itch and urticaria activity scores by 50% compared to placebo in the LIBERTY-CUPID Study C. The safety profile of Dupixent remained consistent with previous findings, and the study results are expected to be submitted to the FDA by the end of the year.
Sanofi/Regeneron's Dupixent approved by MHRA to treat uncontrolled COPD
Sanofi and Regeneron’s Dupixent approved by MHRA as add-on treatment for uncontrolled COPD in UK, reducing exacerbations and improving lung function.
Evaluating Regeneron Pharmaceuticals And Competitors In Biotechnology Industry
Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.
Dupixent succeeds in chronic hives study, giving Sanofi, Regeneron a chance to rebound
Sanofi and Regeneron plan to resubmit an FDA application for Dupixent in chronic spontaneous urticaria (CSU) by year-end, after a trial showed a 50% reduction in itch and urticaria activity scores. The companies also announced positive results in bullous pemphigoid and plan to seek U.S. approval for this indication. Despite challenges, Dupixent is used by 1 million patients across seven indications, with Japan being the first to approve it for CSU.
Phase 3 LIBERTY-CUPID Study C Trial for Dupilumab Meets Primary, Secondary Endpoints
Phase 3 LIBERTY-CUPID Study C for dupilumab in chronic spontaneous urticaria (CSU) met primary and secondary endpoints, showing dupilumab significantly reduced itch and hives compared to placebo. Dupilumab achieved a 30% complete response rate versus 18% for placebo by week 24, with equivalent adverse event rates. These results support dupilumab's potential as a targeted therapy for CSU, pending FDA approval.
Phase III results send multi-blockbuster closer to another indication
Sanofi and Regeneron's Dupixent meets success criteria in Phase III study for bullous pemphigoid.
Dupixent phase 3 study confirms significant improvements in itch and hives
Dupixent phase 3 study (LIBERTY-CUPID C) confirms significant improvements in itch and hives for CSU patients, meeting primary and key secondary endpoints with a nearly 50% reduction in itch and urticaria activity scores compared to placebo. Data supports regulatory resubmission in the US by year-end, aiming for Dupixent to become the first targeted therapy for CSU in a decade.
Sanofi and Regeneron's Dupixent succeeds in trial of chronic hives
Sanofi and Regeneron's Dupixent showed significant improvement in chronic spontaneous urticaria patients in a Phase 3 trial, with 30% achieving complete response versus 18% on placebo, moving closer to FDA approval.
Dupixent data reinforce clinically meaningful benefit from pooled analysis of two COPD studies
Dupixent reduced COPD exacerbations and improved lung function in adults with type 2 inflammation, according to BOREAS and NOTUS phase 3 studies. Dupixent was approved by the European Medicines Agency as an add-on treatment for uncontrolled COPD patients on maximal inhaled therapy. The pooled analysis showed a 31% reduction in exacerbations and a 147 mL improvement in lung function compared to placebo, with safety consistent with known profiles.
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