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. (AMGN) is a global biotechnology leader pioneering innovative therapies for serious illnesses. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's latest developments, regulatory milestones, and strategic initiatives.
Track critical updates across Amgen's core therapeutic areas including oncology treatments, inflammatory disease therapies, and rare disease solutions. Our curated feed includes earnings reports, clinical trial data, partnership announcements, and manufacturing updates - all sourced directly from official channels.
Key resources include timely coverage of FDA decisions, research breakthroughs in biologics and biosimilars, and analysis of market-moving events. Bookmark this page for structured access to Amgen's evolving pipeline and business strategies without promotional bias.
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.
Amgen's investigational drug, sotorasib (AMG 510), displayed promising results in a Phase 2 study involving 126 patients with advanced non-small cell lung cancer (NSCLC) and KRAS G12C mutations. The study revealed a confirmed objective response rate of 37.1% and disease control rate of 80.6%, with a median duration of response of 10 months. Sotorasib is the first of its kind to demonstrate positive effects in this patient population, achieving a median progression-free survival of 6.8 months. Amgen is pursuing regulatory approval across various regions, including the U.S. and Europe.
Amgen (NASDAQ:AMGN) will host a webcast call on January 29, 2021, at 8:00 p.m. ET, in conjunction with the 2020 World Conference on Lung Cancer. The call will feature Dr. David M. Reese and Amgen's clinical team discussing Phase 2 data on their investigational KRASG12C inhibitor, sotorasib, for treating non-small cell lung cancer (NSCLC). The live audio will be accessible online to media, investors, and the public, with replays available for 90 days post-event.
For more details, visit www.amgen.com.
