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 has finalized its acquisition of Teneobio for a total of $900 million in cash, with potential future payments reaching up to $1.6 billion. This strategic move enhances Amgen's capabilities in developing bispecific and multispecific biologics, particularly for treating diseases like metastatic castrate-resistant prostate cancer. The acquisition includes Teneobio's proprietary technologies and investigational therapies, such as TNB-585, expected to accelerate Amgen’s oncology pipeline. Amgen aims to leverage these assets to address critical unmet medical needs in its therapeutic areas.
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.