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Amgen Inc. (NASDAQ: AMGN) is a leading American multinational biopharmaceutical company, established in 1980 and headquartered in Thousand Oaks, California. As one of the largest independent biotechnology companies globally, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on areas of high unmet medical need and leverages its expertise in advanced human genetics to develop solutions that dramatically improve people's lives.
Amgen's portfolio includes a range of flagship drugs such as red blood cell boosters Epogen and Aranesp, immune system enhancers Neupogen and Neulasta, and treatments for inflammatory diseases like Enbrel and Otezla. Additionally, the company has a strong presence in the oncology sector with products like Vectibix, Prolia, Evenity, and Kyprolis. Notably, the acquisition of Onyx Pharmaceuticals bolstered Amgen's oncology portfolio.
Recent launches include innovative therapies such as Repatha for cholesterol management, Aimovig for migraines, Lumakras for lung cancer, and Tezspire for asthma. In 2023, Amgen's acquisition of Horizon Therapeutics introduced several rare-disease drugs to its portfolio, including Tepezza for thyroid eye disease. Amgen also continues to expand its biosimilar portfolio, reinforcing its commitment to making advanced treatments more accessible.
Amgen's financial health is robust, with significant growth in revenues and product sales. The company's strategic partnerships and acquisitions have continually strengthened its market position. For instance, the recent Phase 3 SPROUT study demonstrated the efficacy and safety of Otezla in pediatric patients, highlighting Amgen's ongoing commitment to addressing various health needs. Furthermore, the company’s dedication to innovation is evident from its extensive pipeline of investigational drugs targeting various conditions.
Amgen has been acknowledged for its workplace culture and environmental initiatives, being named one of
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.
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.
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