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 (NASDAQ:AMGN) has released its 2021 Environmental, Social & Governance (ESG) report, outlining its commitment to public health and sustainability. The report highlights four key areas: Healthy People, providing $2.2 billion in free medicines; Healthy Society, impacting 27 million through no-cost science education; Healthy Planet, pursuing carbon neutrality by 2027; and A Healthy Amgen, integrating ESG goals into business practices. Recognized by various organizations, Amgen continues to emphasize its role in improving health outcomes and addressing societal challenges.
Amgen reported Q1 2022 total revenues of $6.2 billion, a 6% increase from Q1 2021, driven by 2% growth in product sales and enhanced COVID-19 collaboration revenue. GAAP EPS decreased by 5% to $2.68, while non-GAAP EPS increased by 15% to $4.25. Operating income grew 17% to $2.5 billion, improving the operating margin to 43.6%. Amgen reaffirmed total revenue guidance for 2022 at $25.4-$26.5 billion while adjusting GAAP EPS guidance to $12.53-$13.58. Challenges include IRS tax disputes potentially increasing liabilities by $7.1 billion.
Amgen has released positive results from two open-label extension studies evaluating the long-term safety and tolerability of Repatha (evolocumab) in over 6,600 patients. These studies, following the Phase 3 FOURIER trial, show that Repatha is safe for extended use, with no new safety issues reported over five years. More than 85% of patients achieved LDL-C levels below 40 mg/dL. Amgen emphasizes Repatha's sustained effectiveness in lowering LDL-C in patients with atherosclerotic cardiovascular disease, reinforcing its position as a leader in PCSK9 inhibitors.
Amgen (NASDAQ:AMGN) plans to announce its first quarter financial results on April 27, 2022, after U.S. market close, followed by a conference call at 2:00 p.m. PT. The call will include CEO Robert A. Bradway and senior management, and will be accessible via live audio broadcast online. The conference will discuss Amgen's ongoing commitment to developing innovative therapies and its strong market position as a leading biotechnology company since 1980. More information and the webcast can be found on Amgen's website.
Amgen announced preliminary results from a Phase 3 study of ABP 654, a biosimilar candidate to STELARA (ustekinumab), for treating moderate to severe plaque psoriasis. The primary efficacy analysis showed no clinically meaningful differences between ABP 654 and STELARA, with a mean difference of 0.14 in percentage improvement in psoriasis area severity index (PASI) from baseline to week 12. The safety profile was comparable between both treatments. Amgen aims to expand its biosimilars portfolio, which includes 11 candidates.
Amgen announced significant long-term clinical results from the CodeBreaK 100 trial, focusing on its KRASG12C inhibitor, LUMAKRAS® (sotorasib), for advanced non-small cell lung cancer (NSCLC). In this two-year follow-up of 174 patients, a 40.7% objective response rate (ORR) was observed, with a disease control rate (DCR) of 83.7%. The median duration of response was 12.3 months, and overall survival reached 12.5 months. Importantly, no new safety concerns were reported, affirming LUMAKRAS's position as a leading treatment for KRAS G12C-mutated NSCLC.
Amgen presented new data on Otezla (apremilast) for treating plaque psoriasis at the American Academy of Dermatology congress in Boston from March 25-29, 2022. This data reinforces its clinical benefits for patients with mild to moderate plaque psoriasis and palmoplantar pustulosis. Otezla is the first FDA-approved oral therapy for plaque psoriasis across all severity levels. Key results from ongoing studies, including PROMINENT and ADVANCE, demonstrate Otezla's efficacy, while safety profiles remain consistent with prior findings. Major abstracts will be presented on March 27, 2022.
Amgen will present virtually at the 32nd Annual Oppenheimer Healthcare Conference on March 16, 2022, at 11:20 a.m. ET. The presentation will be conducted by Rob Lenz, M.D., Ph.D., and Peter H. Griffith, focusing on Amgen's business developments. The webcast will be accessible to the public through Amgen's website, with an archive available for 90 days post-event. Amgen is a leading biotechnology firm, committed to improving health outcomes through innovative human therapeutics, and is recognized as one of the top sustainable companies globally.
Amgen (NASDAQ: AMGN) will present crucial data from its oncology portfolio at the AACR Annual Meeting in New Orleans, April 8-13, 2022. A highlight will be the late-breaking oral presentation of long-term outcomes from the CodeBreaK 100 trial for LUMAKRAS® (sotorasib), a KRASG12C inhibitor for non-small cell lung cancer (NSCLC), on April 10. Additional data will cover preclinical results from AMG 794 and TNB-928b. Over 40 countries have approved LUMAKRAS, which has been administered to more than 4,000 patients globally.
Amgen (NASDAQ:AMGN) has commenced construction on a new biomanufacturing facility in Holly Springs, North Carolina, aimed to be operational by 2025. This facility will enhance Amgen's capability to meet the rising demand for its medicines targeting severe health issues like cancer and heart disease, creating over 350 high-quality jobs.
The plant will utilize advanced technologies to maximize production efficiency and adhere to strict environmental standards, supporting Amgen's goal of carbon neutrality by 2027.