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.
About Amgen Inc.
Amgen Inc. (NASDAQ: AMGN) is a leading multinational biopharmaceutical company headquartered in Thousand Oaks, California. Founded in 1980, Amgen is one of the world's largest independent biotechnology firms, pioneering the development of innovative medicines that leverage human genetic data to address some of the most challenging diseases. With a mission to serve patients, Amgen focuses on using cutting-edge science and technology to discover, develop, manufacture, and deliver transformative therapies.
Core Therapeutic Areas
Amgen's portfolio spans several therapeutic areas, including:
- Oncology: Amgen develops targeted therapies for cancers, such as LUMAKRAS® for KRAS G12C-mutated non-small cell lung cancer and BLINCYTO® for B-cell acute lymphoblastic leukemia (B-ALL).
- Inflammation: Products like TEZSPIRE® (tezepelumab) address severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
- Cardiovascular Diseases: Repatha® is a leading treatment for lowering LDL cholesterol and reducing cardiovascular risks.
- Rare Diseases: Amgen's acquisition of Horizon Therapeutics has expanded its rare disease portfolio, including treatments like TEPEZZA® for thyroid eye disease.
- Obesity and Metabolic Health: Investigational therapies like MariTide (AMG 133) are being developed to address obesity and Type 2 diabetes.
Innovative Platforms and Research
Amgen’s commitment to innovation is evident in its use of advanced platforms such as:
- BiTE® Technology: A pioneering immuno-oncology platform that engages T-cells to target cancer cells.
- Biosimilars: Amgen has a growing portfolio of biosimilars, offering cost-effective alternatives to existing biologics.
- Human Genetics: Through its subsidiary deCODE genetics, Amgen leverages genetic insights to identify disease pathways and develop precision medicines.
Strategic Collaborations and Acquisitions
Amgen actively collaborates with industry leaders like AstraZeneca and Kyowa Kirin to co-develop therapies such as TEZSPIRE and rocatinlimab. Its acquisition of Horizon Therapeutics has bolstered its portfolio in rare diseases, while its expertise in manufacturing ensures scalable production of biologics and biosimilars.
Market Position and Impact
Amgen is recognized for its strong financial performance and innovative pipeline. It is a component of the Dow Jones Industrial Average® and Nasdaq-100 Index®, reflecting its influence in the biopharmaceutical sector. The company’s global reach ensures access to life-saving therapies for millions of patients worldwide, while its robust R&D investments position it as a leader in addressing unmet medical needs.
Commitment to Sustainability and Ethics
Amgen is dedicated to environmental, social, and governance (ESG) initiatives, aiming to reduce its carbon footprint and enhance access to medicines. Its focus on ethical practices and patient-centric innovation underscores its role as a trusted leader in biotechnology.
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.
On September 16, 2021, Amgen announced promising results from the Phase 1b/2 CodeBreaK 101 study, evaluating the combination of LUMAKRAS (sotorasib) and Vectibix (panitumumab) in patients with KRAS G12C-mutated advanced colorectal cancer (CRC). The trial revealed an overall objective response rate (ORR) of 27% among 26 patients, significantly higher than the 9.7% observed with LUMAKRAS monotherapy. A new Phase 3 trial will begin in the third-line setting. The safety profile was manageable, with no severe adverse effects noted. Results were presented at the ESMO21 Virtual Congress.
Amgen and The Lundquist Institute have awarded the first Amgen Golden Ticket to Diadem Biotherapeutics, allowing them one year of lab space at BioLabs LA. Selected during a virtual pitch event, Diadem will benefit from Amgen's mentorship as they advance novel immunotherapies. This initiative aims to foster life science startups in Southern California, with two more tickets to be awarded in the next three years. The partnership reflects Amgen's commitment to innovation and support for the burgeoning biotech ecosystem in Los Angeles.
Amgen (NASDAQ: AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference on September 17, 2021, at 11:45 a.m. ET. Peter H. Griffith, executive vice president and CFO, will lead the presentation. A live audio webcast will be available via Amgen's website for the media, investors, and the public. The presentation will be archived for seven days after the event. Amgen, a biotechnology leader since 1980, focuses on serious illnesses and aims to improve health outcomes worldwide.
Amgen will host a live webcast on Sept. 16, 2021, at 8:30 a.m. ET, featuring David M. Reese, M.D., discussing clinical data on the KRASG12C inhibitor LUMAKRAS™ (sotorasib) alongside Vectibix® (panitumumab) during the ESMO 2021 Congress. The event is open to the investment community, media, and the public, accessible via Amgen's website. Archived playback will be available for at least 90 days post-event. Founded in 1980, Amgen is a leading biotechnology firm focused on innovative therapeutics for serious diseases.
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