Welcome to our dedicated page for Amgen news (Ticker: AMGN), a resource for investors and traders seeking the latest updates and insights on Amgen stock.
News about Amgen Inc. (AMGN) centers on its biotechnology medicines, clinical milestones, corporate transactions and investor communications. The company describes itself as discovering, developing, manufacturing and delivering medicines for cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases, and its news flow reflects activity across these therapeutic areas.
Investors following AMGN news can see updates on regulatory decisions and clinical data for key products. Recent announcements include U.S. Food and Drug Administration approvals and label expansions, such as full approval for IMDELLTRA (tarlatamab-dlle) in extensive stage small cell lung cancer after progression on platinum-based chemotherapy, and approval of UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis who are anti-acetylcholine receptor and anti-MuSK antibody positive. Amgen has also reported landmark cardiovascular outcomes data for Repatha (evolocumab) from the VESALIUS-CV trial.
Corporate development and pipeline news are another focus. Amgen has announced the acquisition of Dark Blue Therapeutics, a biotechnology company developing targeted protein degraders for oncology, adding an investigational MLLT1/3-targeting molecule for acute myeloid leukemia to its portfolio. The company also issues releases on capital allocation decisions, such as dividend declarations, and on participation in major healthcare investment conferences where management discusses business developments.
This AMGN news page allows readers to track company press releases and related coverage, including clinical trial readouts, FDA decisions, acquisitions, pricing and access initiatives, and presentations at scientific and investor meetings. Users interested in biotechnology, oncology innovation, cardiovascular outcomes and large-cap healthcare equities can monitor these updates as part of their ongoing research on Amgen stock.
Amgen will present at the Cowen 4th Annual Virtual IO Summit on November 13, 2020, at 3:30 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development, will lead the presentation. Live audio will stream from Amgen's website, with a replay available for 90 days post-event. Amgen, a leader in biotechnology since 1980, focuses on innovative human therapeutics to address serious illnesses and unmet medical needs. The company is dedicated to improving health outcomes globally.
Amgen and AstraZeneca have announced positive results from the Phase 3 NAVIGATOR trial for tezepelumab, which showed a statistically significant reduction in asthma exacerbations compared to placebo over 52 weeks. The trial met its primary endpoint, demonstrating efficacy across varying eosinophil counts. Tezepelumab's well-tolerated profile and the Breakthrough Therapy Designation from the FDA underscore its potential as a first-in-class asthma treatment. Both companies will share costs and profits in the collaboration to commercialize this promising drug.
Amgen (NASDAQ:AMGN) announced the presentation of important data from its cardiovascular portfolio at the American Heart Association Scientific Sessions 2020, scheduled for Nov. 13-17, 2020. Key highlights include new evidence supporting Repatha (evolocumab) for lowering cardiovascular events, the GOULD registry's findings on cholesterol treatment patterns, and initial data for olpasiran, an innovative siRNA targeting lipoprotein(a). Results from the GALACTIC-HF trial, which met its primary endpoint but missed its secondary one, will also be showcased, emphasizing Amgen's commitment to improving cardiovascular health.
Amgen (NASDAQ: AMGN) announced the first presentation of AMG 757 Phase 1 clinical data for relapsed or refractory small cell lung cancer (SCLC). The investigational bispecific T cell engager targets the DLL3 protein, overexpressed in SCLC. The interim analysis involved 40 patients, with 16% showing confirmed partial response and 29% with stable disease. Despite a 43% incidence of cytokine release syndrome (CRS), events were manageable. Results will be presented on Nov. 12 at the SITC 35th Annual Meeting, highlighting potential advancements in treating this aggressive cancer.
Amgen (NASDAQ:AMGN) will present at the 29th Annual Credit Suisse Virtual Healthcare Conference on Nov. 9, 2020, at 4:15 p.m. ET in Scottsdale, Ariz. Key executives, Murdo Gordon and Peter H. Griffith, will be representing the company. Investors can listen to the live audio on Amgen's website, with a replay available for 90 days. Founded in 1980, Amgen focuses on addressing unmet medical needs through innovative therapies and advanced human genetics. For more details, visit www.amgen.com.
Amgen reported Q3 2020 financial results with total revenues of $6.4 billion, up 12% year-over-year, driven by significant volume growth despite challenges due to COVID-19. Product sales also rose 12%, with notable increases in Otezla® and Repatha®. GAAP EPS increased 5% to $3.43, while non-GAAP EPS saw a 19% rise to $4.37. Free cash flow remained stable at $3.2 billion. Amgen narrowed its total revenue guidance for 2020 to $25.1-$25.5 billion and revised EPS guidance upwards.
Amgen (NASDAQ:AMGN) will release its third quarter financial results on October 28, 2020, after U.S. market close. Following this, a conference call will occur at 2:00 p.m. PT, featuring CEO Robert A. Bradway and senior management. The call will be accessible via live audio on Amgen's website, where it will also be archived for 90 days. Amgen continues to focus on innovative therapeutics, addressing high unmet medical needs, and has built a strong pipeline since its inception in 1980.
Amgen has completed discussions with the FDA regarding its Phase 2 trial for efavaleukin alfa, aimed at treating Systemic Lupus Erythematosus (SLE). This initiative is part of the FDA's Complex Innovative Trial Designs Pilot Program, focusing on modernizing drug development. The adaptive clinical trial design is expected to enhance the development of new therapies for SLE, addressing the significant unmet medical need in this area. The collaboration signals a commitment to improve efficiency and innovation in clinical trials.
Amgen (NASDAQ:AMGN) declared a $1.60 per share dividend for Q4 2020, payable on December 8, 2020, to shareholders recorded by November 16, 2020. This follows Amgen's commitment to improve health outcomes through innovative therapies, supported by a strong pipeline and advanced human genetics. The company, a pioneer in biotechnology since 1980, focuses on serious illnesses and has reached millions globally.
Amgen announced positive Phase 2 results for sotorasib, a KRAS G12C inhibitor, in treating advanced non-small cell lung cancer (NSCLC) in patients with prior treatment failures. The study involved 126 patients, showing an objective response rate consistent with past Phase 1 data and promising efficacy measures. More than half of responders remained on treatment at data cutoff. Amgen plans to discuss results with regulatory agencies and is advancing its development program, which includes a Phase 3 study, CodeBreaK 200, comparing sotorasib to docetaxel.