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 (AMGN) announced the FDA approval for expanding the KYPROLIS (carfilzomib) labeling to include its use in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and dexamethasone for treating relapsed or refractory multiple myeloma in adults with one to three prior therapies. The decision is based on the Phase 2 PLEIADES study, showing an impressively high overall response rate of 84.8%. This combination aims to enhance patient convenience by reducing administration time and burden. Amgen plans to submit global marketing applications soon.
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Amgen (NASDAQ:AMGN) will present at the 2021 Evercore ISI Healthcare Conference on Nov. 30, 2021, at 5:10 p.m. ET. Rob Lenz, M.D., Ph.D., Amgen's Senior Vice President of Global Development, will lead the presentation, which can be accessed via a live audio webcast for media, investors, and the public. The webcast will be archived for 90 days post-event. Amgen, a biotechnology leader since 1980, focuses on innovative human therapeutics to address serious diseases and improve health outcomes for patients worldwide.
Amgen (NASDAQ:AMGN) will present at the 2021 Piper Sandler Healthcare Conference on Dec. 1, 2021, at 1:00 p.m. ET. Notable executives Murdo Gordon and Peter H. Griffith will represent the company. The presentation will be available via a live audio webcast accessible to the media, investors, and the public. Following the event, the webcast will be archived for at least 90 days. Amgen is dedicated to developing innovative therapeutics to address serious health conditions, leveraging advanced genetics to enhance patient outcomes.
Amgen (NASDAQ:AMGN) has awarded a $25,000 grant to the Bath Institute of Rheumatic Diseases (BIRD) as part of the UPLIFT Innovation Challenge. This initiative aims to improve solutions for those living with psoriatic disease. BIRD's project focuses on connecting patients and healthcare providers through digital platforms, enhancing understanding and communication. Additionally, four other organizations received honorable mentions, each receiving a $20,000 grant. The challenge emerged from findings of the 2020 UPLIFT survey, highlighting gaps in care for psoriatic disease patients.
Amgen (NASDAQ: AMGN) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending conditional marketing authorization for LUMYKRAS® (sotorasib) to treat adults with advanced non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation. This marks a significant step towards the first targeted therapy for this mutation in the EU. The decision is based on the Phase 2 CodeBreaK 100 clinical trial, which showed a 37.1% objective response rate and 12.5 months median overall survival. A decision from the European Commission is expected by mid-January 2022.
Amgen will present at the 2021 Cowen IO Summit on November 15 at 2:15 p.m. ET. Dr. David M. Reese, Executive VP of Research and Development, will lead the presentation. The event will be accessible via live audio webcast for media, investors, and the public on Amgen's website. An archived version will be available for 90 days post-event. Amgen is recognized for its innovative biotechnological approaches to serious illnesses, leveraging human genetics to enhance health outcomes for millions globally.
Amgen announced positive results from the HER-MES study, the first head-to-head trial comparing Aimovig® (erenumab-aooe) to topiramate for migraine prevention. The study demonstrated a significantly lower discontinuation rate due to adverse events (10.6% for Aimovig vs. 38.9% for topiramate) and superior efficacy, with 55.4% of Aimovig patients achieving at least a 50% reduction in monthly migraine days. The findings, published in Cephalalgia, strengthen Aimovig's profile as a migraine treatment, highlighting its potential for wider adoption among patients suffering from this debilitating condition.
Amgen has initiated construction of a new biomanufacturing plant in New Albany, Ohio, with an investment of $365 million, set to become operational by 2024. This facility will create approximately 400 jobs and aims to meet increasing demand for Amgen's medicines in the U.S. The plant is designed to be the company's most efficient and sustainable, with plans for LEED certification. Additionally, Amgen has received accolades for workplace diversity and aims to hire a million Black Americans in the next decade. This expansion marks a significant move for Amgen in maintaining its leadership in biologics.
Amgen (AMGN) reported Q3 2021 revenues of $6.7 billion, marking a 4% year-on-year increase, driven by strong unit demand. GAAP EPS fell 3% to $3.31 due to a $400 million licensing expense, while non-GAAP EPS rose 11% to $4.67. The company generated $2.2 billion in free cash flow but this was a decline from $3.2 billion in Q3 2020. Amgen maintained its full-year revenue guidance between $25.8 billion and $26.2 billion, with GAAP EPS projected at $9.55-$10.21. New product LUMAKRAS showed promising sales, and a robust pipeline is expected to drive long-term growth.