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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 (NASDAQ: AMGN) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, a KRASG12C inhibitor aimed at treating adult patients with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC). This submission reflects Amgen's commitment to expedite the clinical program for sotorasib, which has shown positive outcomes in Phase 2 trials. With approximately 33,000 new KRAS G12C NSCLC cases diagnosed annually in the EU-27, this therapy addresses a significant unmet medical need.
Amgen and AstraZeneca announced that the SOURCE trial did not achieve its primary endpoint of significantly reducing daily oral corticosteroid (OCS) doses in severe asthma patients treated with tezepelumab compared to placebo. The 48-week trial involved 150 patients and aimed to assess tezepelumab's efficacy and safety. Despite the SOURCE results, previous trials, including the NAVIGATOR study, showed promising outcomes with tezepelumab, which is designed to block thymic stromal lymphopoietin (TSLP) involved in asthma inflammation. Further analyses are ongoing, and safety profiles remain consistent with prior studies.
Amgen (NASDAQ: AMGN) and LabCentral announced the winners of the Amgen Golden Ticket for 2020, awarded to Octagon Therapeutics and Seranova Bio. Chosen during a virtual pitch event, these biotech start-ups will receive one year of free bench space and mentorship from Amgen scientists. Octagon is developing targeted immunomodulators for autoimmune diseases, while Seranova is focused on novel therapeutic target discovery using its advanced REAP platform. This initiative highlights Amgen's commitment to supporting innovative life sciences companies.
Amgen announced FDA approval for RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, for treating adult patients with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis. RIABNI will launch in the U.S. in January 2021, priced 23.7% lower than Rituxan, at $716.80 per 100 mg and $3,584.00 per 500 mg. The approval reinforces Amgen's commitment to providing affordable biosimilars and follows the success of KANJINTI and MVASI. Clinical studies show RIABNI is clinically equivalent to Rituxan in safety and efficacy.
Amgen announced the transfer of its 1.250% Senior Notes due 2022 and 2.00% Senior Notes due 2026 listings from the New York Stock Exchange to the Nasdaq Bond Exchange, effective December 28, 2020. This move consolidates its equity and debt listing relationships under one exchange. The Debt Securities will trade on Nasdaq starting December 29, 2020. The trading symbols are AMGN22 for the 2022 notes and AMGN26 for the 2026 notes.
Amgen (NASDAQ:AMGN) has declared a $1.76 per share dividend for Q1 2021, to be paid on March 8, 2021, to stockholders of record by February 15, 2021. This marks a 10% increase from the prior four quarters. The company continues its commitment to innovative therapeutics, addressing serious illnesses, and focusing on high unmet medical needs. Investors can view additional information on Amgen's offerings via their official site.
Amgen has submitted a New Drug Application (NDA) for sotorasib, a KRASG12C inhibitor, to the FDA for treating advanced non-small cell lung cancer (NSCLC). Sotorasib shows promise as the first approved targeted therapy for KRAS G12C mutation, found in about 13% of NSCLC patients. The NDA is supported by positive Phase 2 data from the CodeBreaK 100 study, demonstrating durable anticancer activity. The FDA will review the application under the Real-Time Oncology Review program, aiming for expedited access to effective treatments.
Amgen announced that the FDA granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, aimed at treating patients with advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. This designation underscores the unmet clinical need in a patient population lacking targeted therapies. Sotorasib is being tested in the CodeBreaK clinical program across 13 tumor types, with positive Phase 2 results indicating durable anticancer activity. Amgen plans to submit a new drug application by year-end 2020.
Amgen (NASDAQ:AMGN) has partnered with Karamo Brown to launch the Know Migraine Mission, aimed at increasing awareness and understanding of migraine. Karamo, who has suffered from migraines since high school, will share his experiences and encourage open conversations about the condition. Aimovig®, co-marketed with Novartis, is the first FDA-approved treatment for migraine prevention. The initiative focuses on combating stigma and promoting the significance of discussing migraine challenges, highlighting Aimovig's proven efficacy in reducing monthly migraine days.
Amgen announced its first presentation of clinical data for AMG 701, a half-life extended bispecific T cell engager, at the ASH Annual Meeting. Targeting BCMA, this immuno-oncology therapy was evaluated in 85 heavily pre-treated patients with relapsed/refractory multiple myeloma. The study revealed a 36% response rate, with some patients experiencing responses lasting up to 26 months. Adverse events included anemia (42%) and cytokine release syndrome (65%). This data emphasizes Amgen's commitment to innovative cancer treatments and the potential of the BiTE platform in addressing unmet medical needs.
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