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 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.
Amgen announced that the U.S. District Court for New Jersey upheld patents protecting its psoriasis treatment, Otezla (apremilast), from generic competition by Sandoz and Zydus. The court affirmed four patents, preventing these companies from producing generics until February 2028. Although Amgen succeeded in most claims, the court ruled against it concerning a specific dosing schedule patent. Otezla is approved for treating moderate-to-severe plaque psoriasis, psoriatic arthritis, and oral ulcers in Behçet's Disease.