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 and AstraZeneca announced positive results from the NAVIGATOR Phase 3 trial for tezepelumab as a potential first-in-class treatment for severe asthma. The trial demonstrated a 56% reduction in the annualized asthma exacerbation rate (AAER) when added to standard care over 52 weeks compared to placebo (p<0.001). Key secondary endpoints also showed significant improvements in lung function and quality of life. There were no significant safety differences between tezepelumab and placebo. Tezepelumab is a promising option for patients with severe asthma, regardless of eosinophil count.
Amgen (NASDAQ:AMGN) will participate in the Cowen 41st Annual Virtual Healthcare Conference on March 4, 2021, at 12:50 p.m. ET. Presenters include Murdo Gordon, EVP of Global Commercial Operations, and Peter H. Griffith, CFO. The presentation will be accessible live via Amgen's website and available as a replay for at least 90 days. Amgen is dedicated to developing innovative therapies for serious illnesses through advanced genetics and biotechnology. The company aims to address high unmet medical needs and improve health outcomes globally.
Amgen will host a webcast for investors on February 26, 2021, at 1:00 p.m. ET, during the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The call will feature David M. Reese, M.D., discussing the tezepelumab Phase 3 NAVIGATOR study results for severe asthma patients, alongside clinical trial investigators. The live audio will be accessible via Amgen's website, with an archive available for 90 days post-event. Amgen focuses on innovative therapeutics and addressing significant medical needs.
Amgen announced the submission of a supplemental New Drug Application (sNDA) for Otezla (apremilast) to the FDA for treating adults with mild-to-moderate plaque psoriasis. The submission is based on positive Phase 3 ADVANCE trial results, showing statistically significant improvement in the primary endpoint over placebo. The study involved 595 patients, with Otezla demonstrating effectiveness in various secondary endpoints. Otezla is already approved for moderate-to-severe plaque psoriasis and has been used by over 250,000 patients in the U.S. since its 2014 approval.
Amgen announced that the FDA has granted Priority Review for sotorasib, a treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This designation signifies potential significant improvements in treatment options. The Prescription Drug User Fee Action (PDUFA) date is set for Aug. 16, 2021, four months earlier than the standard review. The New Drug Application is based on Phase 2 results from the CodeBreaK 100 trial, which enrolled 126 patients. Sotorasib has also received Breakthrough Therapy Designation in the U.S. and China.
Amgen (NASDAQ:AMGN) announced that Greg Friberg, its global oncology head, will participate in a fireside chat during the Guggenheim Healthcare Talks 2021 Oncology Day on February 12 at 12:30 p.m. ET. The live audio of the event will be available online for media, investors, and the public. Interested parties can access the webcast through Amgen's website, and it will be archived for 90 days post-event. Amgen is dedicated to developing innovative therapeutics for serious illnesses, focusing on high unmet medical needs and leveraging advanced human genetics.
Amgen (NASDAQ:AMGN) has announced a three-year sponsorship of the BioLabs LA at The Lundquist Institute to support emerging life sciences. This partnership will introduce the "Amgen Golden Ticket" award, granting one startup annual access to lab space and Amgen's resources for three years. This initiative aims to bolster the biotech ecosystem in Southern California, providing startups with essential infrastructure and mentorship. Amgen is committed to fostering innovation in areas of high unmet medical need.
Amgen (AMGN) reported strong financial results for Q4 and FY2020, with total revenues increasing by 7% to $6.6 billion in Q4, and by 9% to $25.4 billion for the full year. Product sales rose 8% in Q4, bolstered by a 13% volume growth across its portfolio. However, GAAP EPS decreased 3% in Q4 and 4% for the full year, primarily due to amortization costs from the Otezla acquisition. Non-GAAP EPS increased 5% in Q4 and 12% for the year. Amgen anticipates revenue guidance for 2021 between $25.8-$26.6 billion.
Amgen announced that its KRASG12C inhibitor, sotorasib, received Breakthrough Therapy Designation from China's NMPA, targeting patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). This is Amgen's first BTD submission in China and highlights its collaboration with BeiGene. The designation follows positive results from the CodeBreaK 100 Phase 2 study, demonstrating durable anticancer activity. Sotorasib aims to be the first targeted therapy for this mutation in China, addressing a significant medical need with 3-5% of NSCLC patients affected.
Amgen (NASDAQ:AMGN) will report its Q4 and full year 2020 financial results on Feb. 2, 2021, after the close of U.S. markets. Following the announcement, a conference call will be held at 5 p.m. EST featuring CEO Robert A. Bradway and senior management. Investors and the public can access the live audio via Amgen's website. Amgen is dedicated to innovative therapeutics, leveraging advanced human genetics to address serious health issues.
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