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. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Dupixent (dupilumab) to treat children aged 6 to 11 years with severe asthma characterized by type 2 inflammation. This recommendation is based on a Phase 3 trial demonstrating significant reductions in severe asthma attacks and improved lung function. The European Commission is expected to make a final decision soon. Dupixent is already FDA-approved for similar indications in the U.S. and has shown a well-established safety profile.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have voluntarily withdrawn the supplemental Biologics License Application for Libtayo (cemiplimab) as a second-line treatment for advanced cervical cancer after failing to align with the FDA on post-marketing studies. Approximately 570,000 cervical cancer cases are diagnosed globally each year. Current indications for Libtayo include advanced basal cell carcinoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer, but it is not approved for advanced cervical cancer.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the 40 finalists for the 2022 Regeneron Science Talent Search, highlighting the top high school scholars in STEM. Selected from 1,804 entrants, these finalists demonstrate significant research potential across diverse fields, including COVID-19 impact studies and novel therapeutic tools. The finalists compete for over $1.8 million in awards, with each receiving at least $25,000. The winners will be announced during a live-streamed ceremony on March 15, 2022. This initiative reflects Regeneron's commitment to supporting future science leaders.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted its supplemental Biologics License Application for Libtayo® (cemiplimab-rwlc) in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC). This application is supported by a Phase 3 trial, demonstrating significant overall survival improvement over chemotherapy alone, leading to early termination of the trial. Libtayo is already approved for patients with high PD-L1 expression. A regulatory filing has also been submitted to the European Medicines Agency.
Regeneron Pharmaceuticals and Sanofi have announced positive results from a second Phase 3 trial of Dupixent (dupilumab) for uncontrolled prurigo nodularis. The PRIME trial demonstrated that 60% of patients on Dupixent achieved significant itch reduction, compared to only 18% for the placebo group, at 24 weeks. Additionally, 48% of Dupixent patients experienced near-clear skin compared to 18% in the placebo group. The safety profile remained consistent with previous studies, with lower skin infection rates noted. These findings further support Dupixent's efficacy in addressing type 2 inflammatory diseases.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced its fourth quarter and full year 2021 financial results will be reported on February 4, 2022, before U.S. market opening. A conference call and webcast will occur at 8:30 AM ET on the same day. Participants can join via webcast on the company’s website.
As a leading biotechnology firm, Regeneron focuses on innovative medicines addressing serious diseases, leveraging proprietary technologies and significant research initiatives.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Ultragenyx Pharmaceutical have announced a collaboration to develop, commercialize, and distribute Evkeeza® (evinacumab) outside the U.S. Regeneron will receive a $30 million upfront payment and is eligible for up to $63 million in additional milestone payments. Evkeeza, approved in the EU in June 2021, is a first-in-class treatment for homozygous familial hypercholesterolemia (HoFH). This partnership aims to enhance patient access to this vital therapy for debilitating genetic conditions globally.
Regeneron Pharmaceuticals (NASDAQ: REGN) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 10:30 a.m. ET. The presentation will be available via webcast on Regeneron's website, with an archived version accessible for 30 days. Regeneron focuses on developing life-transforming medicines, having nine FDA-approved treatments and several candidates in the pipeline. Its proprietary technologies, including VelociSuite, enhance drug development processes, while the Regeneron Genetics Center leads extensive genetic sequencing initiatives.
Regeneron Pharmaceuticals and Sanofi reported positive Phase 3 trial results for Dupixent in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing significant improvements in skin clearance and disease severity. Key results include 28% achieving clear skin versus 4% with placebo, and a 70% average improvement in disease severity. Global regulatory filings are planned, starting with the U.S. by the end of 2021. The safety profile aligns with previous studies in older patients, enhancing expectations for market acceptance.
On December 11, 2021, Regeneron Pharmaceuticals (NASDAQ: REGN) presented new data for REGN5458, a bispecific antibody targeting multiple myeloma, at the ASH Annual Meeting. Results from the Phase 1 portion of the trial showed a 51% overall response rate (ORR) across all dose groups, with a significant boost to 75% at higher doses (200-800 mg). The study reported a 90% probability of being event-free 8 months after response. With 73 patients treated, the safety profile was consistent, showing manageable adverse events.