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.
Amgen Inc. reports developments across its biotechnology medicines business, including discovery, development, manufacturing and delivery of human therapeutics. Company updates center on a portfolio and pipeline spanning cancer, inflammatory conditions, rare diseases, heart disease, obesity and obesity-related conditions, with named products and programs such as TEPEZZA, Repatha and IMDELLTRA appearing in clinical and commercial announcements.
Recurring news also covers quarterly financial results, non-GAAP performance measures, manufacturing network investments, supply-chain capacity, research collaborations, medical and investor conference presentations, and executive or organizational changes tied to the integration of biology, technology, artificial intelligence and data across Amgen's operations.
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.
Amgen (NASDAQ:AMGN) has partnered with Karamo Brown to launch the Know Migraine Mission, aimed at increasing awareness and understanding of migraine. Karamo, who has suffered from migraines since high school, will share his experiences and encourage open conversations about the condition. Aimovig®, co-marketed with Novartis, is the first FDA-approved treatment for migraine prevention. The initiative focuses on combating stigma and promoting the significance of discussing migraine challenges, highlighting Aimovig's proven efficacy in reducing monthly migraine days.
Amgen announced its first presentation of clinical data for AMG 701, a half-life extended bispecific T cell engager, at the ASH Annual Meeting. Targeting BCMA, this immuno-oncology therapy was evaluated in 85 heavily pre-treated patients with relapsed/refractory multiple myeloma. The study revealed a 36% response rate, with some patients experiencing responses lasting up to 26 months. Adverse events included anemia (42%) and cytokine release syndrome (65%). This data emphasizes Amgen's commitment to innovative cancer treatments and the potential of the BiTE platform in addressing unmet medical needs.
Amgen and McKesson have established a multi-year strategic partnership aimed at enhancing cancer care in community oncology settings. With 1 in 5 cancer patients receiving an Amgen treatment and McKesson reaching 20% of U.S. cancer patients, this collaboration intends to optimize access to innovative therapies. The partnership will focus on improving molecular testing, treatment patterns, and utilizing real-world data to enhance patient care. The initiative emphasizes reducing disparities in cancer treatment across diverse demographics.
Amgen (NASDAQ:AMGN) will host a webcast on December 8, 2020, at 4:00 p.m. ET, following the 62nd American Society of Hematology Annual Meeting. Led by David M. Reese, the call will focus on the company's oncology and hematology programs, particularly the innovative BiTE® platform. Key topics will include the first clinical data for AMG 701 and results from a Phase 3 pediatric study of BLINCYTO® (blinatumomab). The webcast will be available on Amgen's website and archived for 90 days.
Amgen (NASDAQ:AMGN) will present key data at the 62nd American Society of Hematology Annual Meeting from Dec. 5-8, 2020. Highlights include findings from the Phase 1 study of AMG 701, targeting BCMA for relapsed/refractory multiple myeloma. The data also features analyses from the BLINCYTO Phase 3 study for children with high-risk B-ALL. Amgen emphasizes its robust bispecific T cell engager (BiTE®) portfolio, showcasing first-in-human data. Additional presentations will cover updates from the KYPROLIS Phase 3 CANDOR study.