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) and Alnylam Pharmaceuticals (Nasdaq: ALNY) announced positive interim results from the Phase 1 clinical study of ALN-APP, an RNAi therapeutic targeting amyloid precursor protein for Alzheimer’s disease and cerebral amyloid angiopathy. The study enrolled 20 patients, revealing that single doses of ALN-APP achieved dose-dependent reductions of soluble APPα and APPβ in cerebrospinal fluid, with decreases of up to 90%. Safety and tolerability were encouraging, with only mild to moderate adverse events reported. This marks the first demonstration of RNAi gene silencing in the human brain, utilizing Alnylam's C16 platform. Further data will be disclosed at an upcoming scientific conference, and the trial continues to explore longer-term effects.
On April 17, 2023, Regeneron Pharmaceuticals (NASDAQ: REGN) announced significant leadership changes. P. Roy Vagelos, M.D., the Chair of the Board since 1995, will retire and not seek reelection at the 2023 Annual Meeting on June 9. Following his departure, Leonard S. Schleifer, M.D., Ph.D., and George D. Yancopoulos, M.D., Ph.D., will serve as Co-Chairs of the Board while maintaining their executive roles. Additionally, Christine A. Poon will become the Lead Independent Director. Dr. Vagelos expressed pride in Regeneron's transformation into a leading biopharmaceutical company, confident in the new leadership's ability to enhance shareholder value.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Bayer announced that their aflibercept 8 mg and EYLEA (aflibercept) injections will be featured in 18 presentations at the upcoming ARVO 2023 Annual Meeting, scheduled for April 23-27.
Key highlights include results from pivotal trials, PULSAR and PHOTON, on the efficacy and safety of aflibercept 8 mg for treating wAMD and DME. Notably, the FDA accepted a Biologics License Application for aflibercept 8 mg, targeting a decision by June 27, 2023. The drug is currently investigational and has not been fully evaluated by regulatory bodies.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced it will release its first quarter 2023 financial results on May 4, 2023, before U.S. markets open. The company will hold a conference call and webcast at 8:30 AM ET to discuss these results. Participants can access the call via the ‘Investors and Media’ section on Regeneron's website. Registration is required for telephone participation, where attendees will receive a confirmation email with access details. Regeneron is renowned for its biotechnology innovations and has developed multiple FDA-approved treatments for severe diseases.
Regeneron Pharmaceuticals announced that the European Commission approved Libtayo (cemiplimab) in combination with chemotherapy for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) showing ≥1% PD-L1 expression. This marks Libtayo's second first-line indication and fifth overall approval in the EU. The decision is based on the successful Phase 3 EMPOWER-Lung 3 trial, which demonstrated significant survival benefits, including a 45% reduction in the risk of death compared to chemotherapy alone. Patients receiving Libtayo had a median overall survival of 22 months versus 13 months for those on chemotherapy alone.
Regeneron Pharmaceuticals (NASDAQ: REGN) has entered a collaboration with Sonoma Biotherapeutics to develop novel regulatory T cell (Treg) therapies for autoimmune diseases. The agreement includes an upfront payment of $75 million, consisting of $45 million in cash and a $30 million equity investment, as well as a potential development milestone payment of $45 million. Both companies will jointly research therapies targeting conditions such as ulcerative colitis and Crohn's disease, sharing R&D costs and profits. Regeneron retains the option to lead late-stage development globally, while Sonoma will co-promote products in the U.S.
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