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 (NASDAQ:AMGN) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 11:50 a.m. PT. CEO Robert A. Bradway will lead the presentation, which will be accessible live via Amgen's website. A replay will be available for 90 days post-event. As a leading biotechnology company, Amgen is focused on advancing therapies for serious illnesses by leveraging human genetics to address unmet medical needs. The company has a robust pipeline and aims to enhance health outcomes for patients globally.
Amgen has entered a licensing agreement with Medicines Development for Global Health (MDGH) for AMG 634, a PDE4 inhibitor aimed at treating tuberculosis and erythema nodosum leprosum. AMG 634 is currently in Phase 2 trials led by the Aurum Institute and The Leprosy Mission Nepal. Amgen acquired the compound during its purchase of Otezla from Celgene in 2019. MDGH will oversee further development and commercialization, with Amgen providing support for ongoing clinical trials. This collaboration aims to address unmet health needs in low- and middle-income countries.
Amgen (NASDAQ: AMGN) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, a KRASG12C inhibitor aimed at treating adult patients with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC). This submission reflects Amgen's commitment to expedite the clinical program for sotorasib, which has shown positive outcomes in Phase 2 trials. With approximately 33,000 new KRAS G12C NSCLC cases diagnosed annually in the EU-27, this therapy addresses a significant unmet medical need.
Amgen and AstraZeneca announced that the SOURCE trial did not achieve its primary endpoint of significantly reducing daily oral corticosteroid (OCS) doses in severe asthma patients treated with tezepelumab compared to placebo. The 48-week trial involved 150 patients and aimed to assess tezepelumab's efficacy and safety. Despite the SOURCE results, previous trials, including the NAVIGATOR study, showed promising outcomes with tezepelumab, which is designed to block thymic stromal lymphopoietin (TSLP) involved in asthma inflammation. Further analyses are ongoing, and safety profiles remain consistent with prior studies.
Amgen (NASDAQ: AMGN) and LabCentral announced the winners of the Amgen Golden Ticket for 2020, awarded to Octagon Therapeutics and Seranova Bio. Chosen during a virtual pitch event, these biotech start-ups will receive one year of free bench space and mentorship from Amgen scientists. Octagon is developing targeted immunomodulators for autoimmune diseases, while Seranova is focused on novel therapeutic target discovery using its advanced REAP platform. This initiative highlights Amgen's commitment to supporting innovative life sciences companies.
Amgen announced FDA approval for RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, for treating adult patients with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis. RIABNI will launch in the U.S. in January 2021, priced 23.7% lower than Rituxan, at $716.80 per 100 mg and $3,584.00 per 500 mg. The approval reinforces Amgen's commitment to providing affordable biosimilars and follows the success of KANJINTI and MVASI. Clinical studies show RIABNI is clinically equivalent to Rituxan in safety and efficacy.
Amgen announced the transfer of its 1.250% Senior Notes due 2022 and 2.00% Senior Notes due 2026 listings from the New York Stock Exchange to the Nasdaq Bond Exchange, effective December 28, 2020. This move consolidates its equity and debt listing relationships under one exchange. The Debt Securities will trade on Nasdaq starting December 29, 2020. The trading symbols are AMGN22 for the 2022 notes and AMGN26 for the 2026 notes.
Amgen (NASDAQ:AMGN) has declared a $1.76 per share dividend for Q1 2021, to be paid on March 8, 2021, to stockholders of record by February 15, 2021. This marks a 10% increase from the prior four quarters. The company continues its commitment to innovative therapeutics, addressing serious illnesses, and focusing on high unmet medical needs. Investors can view additional information on Amgen's offerings via their official site.
Amgen has submitted a New Drug Application (NDA) for sotorasib, a KRASG12C inhibitor, to the FDA for treating advanced non-small cell lung cancer (NSCLC). Sotorasib shows promise as the first approved targeted therapy for KRAS G12C mutation, found in about 13% of NSCLC patients. The NDA is supported by positive Phase 2 data from the CodeBreaK 100 study, demonstrating durable anticancer activity. The FDA will review the application under the Real-Time Oncology Review program, aiming for expedited access to effective treatments.
Amgen announced that the FDA granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, aimed at treating patients with advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. This designation underscores the unmet clinical need in a patient population lacking targeted therapies. Sotorasib is being tested in the CodeBreaK clinical program across 13 tumor types, with positive Phase 2 results indicating durable anticancer activity. Amgen plans to submit a new drug application by year-end 2020.