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. (AMGN) is a global biotechnology leader pioneering innovative therapies for serious illnesses. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's latest developments, regulatory milestones, and strategic initiatives.
Track critical updates across Amgen's core therapeutic areas including oncology treatments, inflammatory disease therapies, and rare disease solutions. Our curated feed includes earnings reports, clinical trial data, partnership announcements, and manufacturing updates - all sourced directly from official channels.
Key resources include timely coverage of FDA decisions, research breakthroughs in biologics and biosimilars, and analysis of market-moving events. Bookmark this page for structured access to Amgen's evolving pipeline and business strategies without promotional bias.
Blade Therapeutics mourns the unexpected passing of its General Counsel and Secretary, Alan C. Mendelson, on October 8, 2021. He was an influential figure in the life sciences sector with over 47 years of experience, significantly contributing to the establishment of Amgen Inc. (NASDAQ: AMGN) in 1980. Blade's CEO, Wendye Robbins, expressed deep condolences, highlighting Mendelson's impact on the industry. His accolades included recognition as one of the most influential lawyers in the United States and the Life Sciences Leadership Award.
Amgen announced results from the Phase 1b CodeBreaK 101 study, investigating the efficacy of LUMAKRAS™ (sotorasib) in combination with afatinib and trametinib for treating KRAS G12C-mutated cancers. The study showed an objective response rate (ORR) of 20% and 35% for LUMAKRAS plus afatinib in heavily pre-treated non-small cell lung cancer patients. For the combination with trametinib, disease control rates were 87% for KRAS G12C inhibitor-naïve NSCLC patients. Safety profiles for both combinations were consistent, with common adverse events including diarrhea and nausea. Amgen continues expanding its LUMAKRAS development program.
On Oct. 7, 2021, Amgen (NASDAQ: AMGN) announced a strategic collaboration with Neumora Therapeutics, focusing on neuroscience innovation. Amgen has invested $100 million in Neumora, which will develop programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases. The partnership will leverage Amgen's deCODE genetics platform and Neumora's precision medicine expertise to enhance drug discovery for conditions like schizophrenia and ALS. This collaboration highlights Amgen's commitment to advancing brain disease treatments despite not conducting internal neuroscience R&D.
On Oct. 4, 2021, Amgen (NASDAQ:AMGN) presented real-world data on hip fracture incidence and treatment trends at the ASBMR Annual Meeting. The study highlighted that hip fractures remain a significant public health issue across various regions, including Asia, Europe, and the Americas. While some countries have seen stabilized or reduced rates, overall treatment rates post-fracture are low, ranging from 11.5% to 50.3%. This suggests a crucial need for improved prevention and treatment strategies, as aging populations contribute to the increasing burden of osteoporosis.
Amgen and Kyowa Kirin announced positive Phase 2 study results of AMG 451/KHK4083 for treating moderate-to-severe atopic dermatitis, presented at EADV 2021. The study, involving 274 patients, met its primary endpoint with significant improvements in Eczema Area and Severity Index (EASI) scores across all treatment groups compared to placebo. Key secondary endpoints also showed positive outcomes. Adverse events were generally mild. Future Phase 3 trials are anticipated to further validate these promising findings, with potential implications for over 30 million affected individuals.
Kyowa Kirin and Amgen announced positive results from a Phase 2 study of KHK4083/AMG 451 for moderate-to-severe atopic dermatitis, presented at the EADV Congress on Oct. 2, 2021. The study met its primary objective, demonstrating statistically significant improvements in Eczema Area and Severity Index (EASI) scores at 16 weeks across all treatment groups compared to placebo. Patients continued to show efficacy improvements beyond 16 weeks, with common adverse events being mild to moderate. Phase 3 trials are expected to begin in the first half of 2022.
Amgen will host a webcast call on Oct. 4, 2021, at 8:30 a.m. ET, in conjunction with the EADV 2021 Congress. The call will feature David M. Reese, M.D., and other management discussing clinical data, particularly from the AMG 451/KHK4083 Phase 2 trial for moderate-to-severe atopic dermatitis. The investor call is open to the public and can be accessed via Amgen’s website. A replay will be available for 90 days post-event.
On September 24, 2021, Amgen announced FDA approval for Repatha® (evolocumab) as an adjunct therapy for pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). This approval follows the Phase 3b HAUSER-RCT study, demonstrating an average LDL-C reduction of 38% with Repatha compared to placebo. The approval aims to address the unmet medical needs of children with genetically high cholesterol. Repatha is already available for older pediatric patients with homozygous familial hypercholesterolemia (HoFH) and is approved in 75 countries worldwide.
Amgen will present at the Cantor Global Healthcare Conference on Sept. 27, 2021, at 2:00 p.m. ET. Susan Sweeney, SVP of Global Marketing, and Peter H. Griffith, CFO, will represent the company. The presentation will be available via live audio on Amgen's website for media, investors, and the public. A replay will be accessible for seven days post-event. Amgen focuses on innovative therapeutics addressing serious illnesses, leveraging advanced human genetics to enhance health outcomes globally.
On Sept. 22, 2021, Amgen released its 8th edition of the Biosimilar Trends Report, highlighting the U.S. biosimilars marketplace across inflammation, oncology, and nephrology. The report indicates that biosimilars have saved the U.S. healthcare system $9.8 billion over five years and could reduce patient out-of-pocket spending by $238 million. It notes that biosimilars launch with prices 15% to 37% lower than reference products, capturing an average market share of 65% in therapeutic areas. The report underscores the importance of competition and education for the sustainable growth of biosimilars.
