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.
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.
Kyowa Kirin Co., Ltd. announced detailed data from a Phase 2 study of KHK4083/AMG 451, a potential first-in-class anti-OX40 monoclonal antibody for treating atopic dermatitis. The findings will be highlighted at the EADV Congress from September 29 to October 2, 2021. The study involved 274 patients, assessing its efficacy and safety through the Eczema Area and Severity Index (EASI) over 16 weeks. KHK4083/AMG 451 leverages advanced POTELLIGENT technology to enhance immune responses and is a collaborative development with Amgen, which will lead global commercialization outside of Japan.
Amgen (NASDAQ: AMGN) announced new data from its inflammation pipeline will be presented at the EADV 30th Congress from Sept. 29 to Oct. 2, 2021. Key highlights include late-breaking results from a Phase 2 study of AMG 451/KHK4083, a potential treatment for moderate-to-severe atopic dermatitis, and new data from the Phase 3 ADVANCE trial on Otezla's efficacy for plaque psoriasis. Amgen aims to share insights into innovative treatments for patients with severe skin conditions, reflecting its commitment to dermatologic diseases advancement.
Amgen (NASDAQ:AMGN) will present at Morgan Stanley's 19th Annual Global Healthcare Conference on September 14, 2021, at 2:45 p.m. ET. CEO Robert A. Bradway will lead the presentation, which will be available for live streaming online, accessible to media, investors, and the public. The webcast can be found on Amgen's official website under the Investors section and will be archived for 90 days post-event. Amgen is known for its focus on discovering and developing innovative therapies aimed at unmet medical needs.
Amgen announced new data from the Phase 2 CodeBreaK 100 trial of LUMAKRAS (sotorasib), the first KRASG12C inhibitor approved in the U.S. for treating KRAS G12C-mutated non-small cell lung cancer (NSCLC). Results showed a 77.5% disease control rate and median overall survival of 8.3 months in patients with stable brain metastases. Furthermore, Amgen is advancing the investigational therapy acapatamab in NSCLC. The findings were presented at the virtual 2021 World Conference on Lung Cancer, highlighting Amgen's commitment to developing targeted therapies for challenging cancers.