Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals Inc. (symbol: REGN) is a prominent American biotechnology company headquartered in Westchester County, New York, since its founding in 1988. The core mission of Regeneron is to discover, develop, and commercialize innovative products targeting a range of serious medical conditions. With a diverse portfolio, Regeneron focuses on therapies for eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.
Among its marketed products, Eylea stands out as a treatment for wet age-related macular degeneration and other eye diseases. Praluent is designed to lower LDL cholesterol levels, while Dupixent addresses multiple immunological conditions. In the oncology sector, Libtayo is a key therapy, and Kevzara targets rheumatoid arthritis.
The company is also heavily invested in the development of monoclonal and bispecific antibodies, often in collaboration with Sanofi and other partners. These initiatives include cutting-edge technologies such as RNA interference (RNAi) with Alnylam and CRISPR-based gene editing with Intellia.
Regeneron's recent progress includes significant advancements in its clinical-stage pipeline, which comprises over 35 product candidates. The company's financial health remains robust, supported by strong revenue streams from collaboration with Sanofi and a strategic $3.0 billion share repurchase program authorized by the board.
Latest updates highlight the company's ongoing efforts in gene therapy, particularly in treating genetic deafness and solid tumors. Regeneron's commitment to pioneering genetic medicine and leveraging data insights from the Regeneron Genetics Center® positions it as a leader in the biopharmaceutical industry.
For more information, visit Regeneron Pharmaceuticals.
Regeneron Pharmaceuticals (REGN) announced key findings from its oncology pipeline at the ESMO IO Congress 2022 in Geneva. The results included initial data on the investigational combination of fianlimab and Libtayo in treating advanced non-small cell lung cancer (NSCLC). The Phase 1 trials indicated a 27% objective response rate in anti-PD-1/PD-L1-naïve patients and a 7% rate in experienced patients, demonstrating potential therapeutic benefits. Safety assessments showed adverse events but no treatment-related deaths. Additional presentations include analyses on melanoma and cervical cancer.
Regeneron Pharmaceuticals, Inc. (REGN) has announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) under Priority Review. This would establish Evkeeza as the first treatment for children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). This condition affects 1,300 patients in the U.S. The trial indicated a significant average LDL-C reduction of 48% after 24 weeks of treatment. The FDA decision is expected by March 30, 2023.
Regeneron Pharmaceuticals announced the European Commission's approval of Libtayo (cemiplimab) for adult patients with recurrent or metastatic cervical cancer after platinum-based chemotherapy. This decision follows positive results from the Phase 3 EMPOWER-Cervical 1 trial, which demonstrated a 31% reduction in the risk of death compared to chemotherapy. Libtayo is now approved for four cancer types in the EU, marking a significant milestone in treatment options for advanced cervical cancer, which affects approximately 600,000 new cases globally each year.
Regeneron Pharmaceuticals and CytomX Therapeutics have entered a significant collaboration to develop next-generation bispecific immunotherapies. CytomX will receive an upfront payment of $30 million and could earn up to $2 billion in future milestones. The collaboration focuses on utilizing CytomX's Probody® technology and Regeneron's Veloci-Bi® platform to create therapies that activate specifically in tumor environments, potentially improving treatment efficacy and reducing side effects. The partnership aims to expand cancer treatment options significantly.
Regeneron Pharmaceuticals and Sanofi announced a positive opinion from the European Medicines Agency (EMA) recommending Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis. If approved, Dupixent will be the first targeted medicine for this condition in the EU. Supported by two pivotal Phase 3 trials, the drug significantly improved itch, skin lesions, and health-related quality of life. Dupixent is already FDA-approved for the same indication in the U.S. The final decision from the European Commission is anticipated shortly.
Regeneron Pharmaceuticals, Inc. announced FDA approval for Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC). This approval extends treatment options to patients regardless of PD-L1 expression or tumor histology. The approval is based on the EMPOWER-Lung 3 trial, which showed a median overall survival of 22 months for the Libtayo combination versus 13 months for chemotherapy alone. This significant improvement supports Libtayo's role in managing NSCLC, aiming for broader patient access.
Regeneron Pharmaceuticals announced late-breaking results from pivotal trials of aflibercept 8 mg for treating diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). The trials PHOTON and PULSAR demonstrated non-inferior vision gains compared to EYLEA at 48 weeks, with 93% and 83% of patients maintaining dosing intervals of 12 weeks or longer, respectively. Additional analyses showed sustained anatomical improvements in both dosing regimens. The safety profile of aflibercept 8 mg was similar to EYLEA, affirming its potential to reduce treatment burden significantly.
Regeneron Pharmaceuticals (REGN) announced that it will present new data at the 2022 American Society of Hematology (ASH) Annual Meeting from December 10-13 in New Orleans. Key highlights include Phase 2 data for odronextamab (CD20xCD3) in relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma and updated data for linvoseltamab (REGN5458) in multiple myeloma. An investor webcast is scheduled for December 14 at 8:30 AM ET to discuss the hematology portfolio further.
Regeneron Pharmaceuticals reported a 15% decrease in Q3 2022 revenues, totaling $2.94 billion, largely due to no sales from REGEN-COV. However, excluding this, revenues grew 11%. EYLEA's U.S. sales reached a record $1.63 billion, and Dupixent global sales rose 40% to $2.33 billion. GAAP diluted EPS was $11.66, down 19% from the previous year. Positive trial results for aflibercept 8 mg in diabetic macular edema and wet AMD were also announced. The FDA extended EYLEA's exclusivity by six months.
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