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's KYPROLIS® (carfilzomib) has received FDA approval for expanded use in combination with DARZALEX® (daratumumab) and dexamethasone (DKd) for treating relapsed or refractory multiple myeloma (R/R MM). This regimen can be administered once or twice weekly and is aimed at patients who have undergone one to three lines of therapy. The Phase 3 CANDOR trial demonstrated a 37% reduction in disease progression risk for DKd compared to Kd alone. The approval meets the growing need for effective treatments following the use of immunomodulatory drugs.
Amgen (NASDAQ:AMGN) has announced new terms for its Exchange Offers, now increasing the maximum principal amount of New Senior Notes to $940 million. The Exchange Offers involve a variety of its Senior Notes, exchanging them for a mix of cash and new notes due 2053. The offers include notable yields such as 2.370% for 6.90% Senior Notes due 2038. The early settlement date for validly tendered notes is set for August 17, 2020. The Exchange Offers are aimed at qualified institutional buyers and select non-U.S. investors only.
Amgen announced early results for its private Exchange Offers to exchange certain series of its senior notes for new Senior Notes due 2053. The total principal amount of New Notes issued will not exceed $800 million, and the New Notes Premium is capped at $350 million. The Exchange Offers include ten series of Old Notes, with a total outstanding principal of approximately $2.19 billion. Validly tendered Old Notes as of August 12, 2020, are prioritized for exchange, with completion expected by August 28, 2020. The Offers are limited to certified institutional holders.
Amgen announced on July 30, 2020, the launch of nine private exchange offers for its outstanding senior notes, totaling up to $800 million in New Notes due 2053. The offers include various senior notes due between 2037 and 2045, with specific cash payment percentages based on acceptance priority levels. The exchange is contingent on meeting certain conditions, including a minimum issuance of $300 million in New Notes and adherence to yield conditions. The offers will expire on August 26, 2020, unless extended. Eligible holders can receive early exchange premiums if they participate by August 12, 2020.
Amgen reported Q2 2020 revenues of $6.2 billion, a 6% increase year-over-year, attributed to 13% volume growth in newer products like Otezla and Repatha. GAAP EPS fell 15% to $3.05, mainly due to amortization from the Otezla acquisition. Non-GAAP EPS rose 7% to $4.25. The company generated $2.7 billion in free cash flow and maintained its 2020 revenues guidance at $25.0-$25.6 billion. Despite COVID-19 impacts on product demand, Amgen continues to navigate the pandemic effectively, with pipeline updates expected soon.
Amgen (NASDAQ:AMGN) will release its second quarter financial results on July 28, 2020, after the U.S. markets close. A conference call will take place at 2:00 p.m. PT, featuring insights from CEO Robert A. Bradway. The call will be accessible via a live audio webcast for the media, investors, and public, with an archived version available for 90 days. Amgen continues to focus on innovative therapeutics for serious illnesses, emphasizing high unmet medical needs, and has established itself as a leading biotechnology company since 1980.
Amgen has appointed Amy E. Miles to its Board of Directors, effective July 23, 2020. Ms. Miles brings extensive experience, having served as the CEO and chair of Regal Entertainment Group. With this appointment, Amgen's Board consists of 12 directors, 11 of whom are independent. Robert A. Bradway, Amgen's chairman and CEO, expressed confidence in Miles' ability to contribute value to the company. Her previous roles include board positions at Norfolk Southern Corporation and Gap Inc., suggesting a strong governance background.
Amgen has announced a significant $421 million investment in BeiGene's direct offering, maintaining a pro rata ownership of approximately 20.3%. This investment underscores Amgen's confidence in their ongoing oncology collaboration in China, the second-largest pharmaceutical market globally. Amgen, a biotechnology leader, focuses on discovering and delivering innovative therapies to address serious diseases, leveraging advanced human genetics.
Amgen announced that the United States Court of Appeals for the Federal Circuit upheld the validity of two patents related to Enbrel® (etanercept). This decision affirms an August 9, 2019 ruling from the New Jersey District Court, which ruled against Sandoz Inc. regarding its biosimilar version of Enbrel. The appellate court's decision upholds a permanent injunction preventing Sandoz from manufacturing or selling its product. This victory is significant for Amgen as it protects its intellectual property and market position for Enbrel.
deCODE genetics, a subsidiary of Amgen, in collaboration with the Icelandic healthcare system and international partners, has published groundbreaking research in Nature on autoimmune thyroid disease (AITD). The study analyzed over 30,000 AITD patients and identified 99 gene sequence variants, with 84 being newly associated with the disease. Notably, a variant in the FLT3 gene was found to significantly elevate the risks of AITD and other autoimmune diseases, as well as nearly double the risk of acute myeloid leukemia (AML). These findings underscore the variant's functional importance in disease pathology.