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.
Optimism Grows in the Fight Against Cancer as Breakthroughs and Funding Increase
Oncolytics Biotech Inc. advances pelareorep therapy, showing significant survival benefits in breast cancer patients. Other biotech companies like Nurix, Incyte, Regeneron, and Foghorn also report promising developments in cancer treatments.
Regeneron Stock Dives As Amgen Tees Up Its Eylea Copycat
A West Virginia judge rejected a preliminary injunction preventing Amgen from launching a biosimilar of Regeneron's eye drug Eylea, causing Regeneron stock to tumble. The FDA approved Amgen's Pavblu, which could launch at risk while the companies are in court. Regeneron plans to appeal, noting the decision only applies to Amgen and the standard dose of Eylea. The court battle could impact Eylea's Medicare negotiations under the Inflation Reduction Act.
Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma
FDA approves Sanofi's Sarclisa for use with Velcade, Bristol Myers' Revlimid, and dexamethasone in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant.
EMA issues positive view on Samsung Bioepis' Eylea biosimilar
Samsung Bioepis received a positive scientific opinion from the EMA’s CHMP for Opuviz (SB15), a biosimilar referencing Eylea, after reviewing its MAA. A positive CHMP opinion typically leads to EC approval within 2-3 months. Opuviz targets ophthalmic diseases like wet AMD, inhibiting VEGF to prevent new blood vessel formation. Biogen, Samsung Bioepis’ partner, will manage European marketing and distribution post-approval.
EMA committee recommends approval of Sanofi & Regeneron's Dupixent to treat ...
EMA's CHMP recommends Dupixent for EoE in children aged 1-11 years, supported by phase 3 EoE KIDS study showing histological remission and symptom improvement. Safety consistent with known profile. Pending EU approval.
Regeneron/Sanofi Dupixent endorsed in EU for eosinophilic esophagitis for children
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Neoadjuvant Dato-DXd, Durvalumab Response Rates Vary in Breast Cancer
Dato-DXd plus durvalumab achieved a 50% pathologic complete response (pCR) rate in stage II/III high-risk HER2-negative breast cancer patients, according to the I-SPY 2.2 trial. The study emphasizes evaluating treatment response per response predictive subtype (RPS) and suggests further investigation in immune-positive and hormone receptor (HR)-negative/DNA damage repair deficiency (DRD)-negative subtypes. The combination's efficacy was supported by the BEGONIA trial, showing a 79% objective response rate in metastatic triple-negative breast cancer. The I-SPY 2.2 trial design uses RPS to optimize drug assignment, aiming to improve efficacy and minimize toxicity.
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ
Samsung Bioepis and Biogen's OPUVIZ™, a biosimilar referencing Eylea (aflibercept), recommended for marketing authorization by the European Medicines Agency for treating neovascular AMD, macular oedema secondary to RVO, DME, and myopic CNV.
Dupixent recommended for pediatric EoE in EU
The CHMP recommends Dupixent for EoE in children aged 1+ in the EU, pending EC approval. Dupixent, co-developed by Regeneron and Sanofi, showed significant histological remission in EoE KIDS Phase 3 trial. Regeneron's financial performance is strong, with Dupixent revenues surging 29% to $3.56 billion. Dupixent also received expanded FDA approval for chronic rhinosinusitis with nasal polyps in adolescents.
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children aged 1-11 years
CHMP recommends EU approval of Dupixent for eosinophilic esophagitis in children aged 1-11 years, based on phase 3 study showing histological remission. If approved, it would be the first treatment for this age group in the EU.
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