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 presented data from the Phase 2 CodeBreaK 100 clinical study at the 2021 ASCO Annual Meeting, demonstrating that LUMAKRAS (sotorasib) provides a median overall survival of 12.5 months in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The study included 124 evaluable patients, showing an objective response rate of 37.1% and a disease control rate of 80.6%. LUMAKRAS received FDA approval on May 28, 2021, under accelerated approval, with ongoing trials expected to confirm clinical benefits.
Amgen announced updated results from the Phase 2 FIGHT trial for bemarituzumab, showing enhanced median overall survival (OS) of 19.2 months with the drug combined with chemotherapy compared to 13.5 months for chemotherapy alone in 155 patients. Notably, patients with over 10% FGFR2b-positive tumors had an OS of 25.4 months versus 11.1 months. Corneal adverse events were more common in the treatment arm (67.1% vs. 10.4%). These results were shared at the ASCO Annual Meeting, reinforcing the drug's potential as a first-in-class therapy for advanced gastric and gastroesophageal cancers, with plans for Phase 3 development.
Amgen (NASDAQ: AMGN) will host a webcast call for investors on June 4, 2021, at 4:00 p.m. ET, during the ASCO Annual Meeting. Dr. David M. Reese and the clinical development team will discuss key clinical data on the FDA-approved KRAS inhibitor LUMAKRAS™ (sotorasib), plus anti-FGFR2b antibody bemarituzumab and the bispecific T-cell engager tarlatamab. The live audio will be accessible to media, investors, and the public via Amgen's website. The recording will remain available for 90 days post-event.
Amgen and Kyowa Kirin have announced a global collaboration to jointly develop KHK4083, a potential first-in-class treatment for moderate-to-severe atopic dermatitis. Amgen will lead the development and commercialization worldwide, except in Japan, where Kyowa Kirin retains rights. The agreement includes a $400 million upfront payment from Amgen and additional milestone payments up to $850 million. KHK4083 has shown promising Phase 2 results, significantly improving symptoms in patients. The partnership builds on a long history of collaboration, leveraging Amgen's expertise and Kyowa Kirin's innovative technology.
Amgen (NASDAQ: AMGN) will present at the 2021 Jefferies Healthcare Conference on June 3, 2021, at 1:30 p.m. ET. Murdo Gordon, executive vice president of Global Commercial Operations, will lead the presentation. The conference call will be streamed live online, accessible to media, investors, and the public. Interested individuals can access the webcast on Amgen's website, where it will also be archived for 90 days.
Amgen specializes in innovative therapeutics and aims to meet high unmet medical needs, enhancing health outcomes globally.
Amgen has received FDA approval for LUMAKRAS™ (sotorasib) to treat adults with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who have undergone at least one prior therapy. This accelerated approval is based on positive data showing a 36% overall response rate and a median duration of response of 10 months from the CodeBreaK 100 trial. The approval represents a significant advancement in targeted therapies for this mutation, which affects about 13% of non-squamous NSCLC patients in the U.S. Amgen is also providing companion diagnostics for effective biomarker testing.
Amgen (NASDAQ: AMGN) will present at the Cowen 2nd Annual Virtual Oncology Innovation Summit on May 21, 2021, at 11:20 a.m. ET. Dr. David M. Reese, the executive vice president of Research and Development, will represent the company. The conference call will be streamed live, accessible to media, investors, and the public via Amgen's website. An archived version of the webcast will be available for at least 90 days post-event. Amgen is committed to discovering and delivering innovative therapies targeting high unmet medical needs, advancing human health since 1980.
Amgen will present at the Cowen 2nd Annual Virtual Oncology Innovation Summit on May 21, 2021, at 11:20 a.m. ET. The presentation will be led by David M. Reese, M.D., Executive Vice President of Research and Development. A live audio broadcast will be available for media, investors, and the public. The webcast can be accessed on Amgen's website and will be available for replay for 90 days. Amgen focuses on delivering innovative human therapeutics to address significant medical needs.
Amgen (NASDAQ: AMGN) announced the presentation of new oncology data at the 2021 ASCO Annual Meeting from June 4-8, 2021. Key highlights include the first-time presentation of overall survival data from the Phase 2 CodeBreaK 100 trial for LUMAKRAS™ (sotorasib) in non-small cell lung cancer (NSCLC). Additionally, updated results for bemarituzumab in advanced gastric cancer will be shared. Amgen’s webcast investor call is set for June 4, 2021, at 4:00 p.m. ET, where executives will discuss these pivotal findings.
Amgen and AstraZeneca reported significant results from the NAVIGATOR Phase 3 trial of tezepelumab, a potential treatment for severe asthma, showcasing superiority across primary and secondary endpoints versus placebo. Key findings include a 77% reduction in annualized asthma exacerbation rates and an 85% reduction in hospitalization rates for patients treated with tezepelumab. Results also indicated improvements in lung function and quality of life. Despite setbacks in the SOURCE Phase 3 trial, where the primary endpoint was not met, further analyses showed promising outcomes for patients on chronic oral corticosteroid therapy.