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 announced that LUMAKRAS (sotorasib) met its primary endpoint of progression-free survival in the Phase 3 CodeBreaK 200 trial, outperforming standard treatment with docetaxel in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The study involved 345 patients who had previously undergone standard chemotherapy and checkpoint inhibitor therapy. Further data will be shared at an upcoming medical congress. LUMAKRAS is approved in over 44 global markets, addressing a critical need for effective treatments in this patient population.
Amgen (AMGN) announced promising results from the Phase 3 SPROUT trial for Otezla (apremilast) in children aged 6-17 with moderate to severe plaque psoriasis. The positive outcomes will be shared at the EADV conference in Milan, Italy, on Sept. 7-10, 2022. Additional results from the Phase 3 DISCREET study on genital psoriasis will also be presented. Further highlights include analyses on rocatinlimab for atopic dermatitis. Amgen emphasizes its commitment to addressing treatment gaps for patients with autoimmune skin diseases.
Amgen presented new data on Repatha (evolocumab) at the ESC 2022, indicating a 20% relative risk reduction in major cardiovascular events and a 23% reduction in cardiovascular deaths for patients treated with Repatha compared to placebo. The Phase 3 FOURIER-OLE studies involved 6,635 patients and showed that 80% achieved LDL-C levels <55 mg/dL at Week 12. The long-term study confirmed the drug's tolerability over up to 8 years, underscoring the importance of early LDL-C lowering in reducing cardiovascular risk.
Amgen announced positive top-line results from the Phase 3 DAHLIA study, evaluating the efficacy of ABP 959, a biosimilar to SOLIRIS, in treating paroxysmal nocturnal hemoglobinuria (PNH). The study met its primary endpoints, showing no significant differences in controlling intravascular hemolysis when compared to SOLIRIS. ABP 959 demonstrated comparable safety and immunogenicity profiles. Amgen aims to work with regulators for potential market availability of this biosimilar, which is similar in formulation and administration to eculizumab, but is currently not commercially available.
Amgen (AMGN) announced the upcoming presentation of cardiovascular research at the European Society of Cardiology Congress 2022, showcasing data on Repatha (evolocumab), including the FOURIER-OLE studies, the longest trials of a PCSK9 inhibitor. These studies reveal that patients received Repatha for a median of 5 years, some for up to 8.5 years, proving significant long-term LDL-C reduction. Presentations will span from August 26 to 29 in Barcelona, covering pivotal findings on Repatha's efficacy and safety.
Amgen presented promising Phase 1 results for tarlatamab, a bispecific T-cell engager targeting DLL3, at the IASLC 2022 conference. The study on 106 heavily pretreated small cell lung cancer (SCLC) patients reported a confirmed overall response rate (ORR) of 23% and a median duration of response of 13 months. The median overall survival was noted at 13.2 months, indicating durability in response. Less than 4% discontinued due to adverse events, positioning tarlatamab as a strong candidate for a Phase 2 study aimed at SCLC, where treatment options are limited.
Amgen presented new data at the IASLC 2022 World Conference on Lung Cancer, focusing on LUMAKRAS® (sotorasib) and tarlatamab for treating lung cancer. A Phase 1b study showed a 29% objective response rate when LUMAKRAS was combined with pembrolizumab or atezolizumab. Additionally, LUMAKRAS combined with RMC-4630 demonstrated a 50% response rate among KRAS G12C inhibitor-naïve patients. Updated data from the tarlatamab trial highlights its potential for small cell lung cancer. Amgen also plans a Phase 2 study for tarlatamab as a third-line treatment.
Amgen reported a 1% increase in total revenues to $6.6 billion for Q2 2022, driven by a 3% growth in global product sales. GAAP EPS soared from $0.81 to $2.45 due to reduced operating expenses, particularly a $1.5 billion IPR&D write-off. Operating income jumped from $0.8 billion to $2.2 billion, with a remarkable 34.6% operating margin. The company revised its 2022 revenue guidance to $25.5-$26.4 billion and reaffirmed its non-GAAP EPS target at $17.00-$18.00.
Amgen announced its acquisition of ChemoCentryx for $52 per share in cash, totaling approximately $3.7 billion. This strategic move enhances Amgen's leadership in inflammation and nephrology, particularly with the inclusion of TAVNEOS (avacopan), a first-in-class treatment for ANCA-associated vasculitis. The acquisition is expected to close in Q4 2022, pending stockholder and regulatory approvals. TAVNEOS had $5.4 million in U.S. sales during its first full quarter. Both companies' boards have unanimously approved the deal.
Amgen has appointed Michael V. Drake, M.D., to its Board of Directors, effective immediately, bringing the board's total to 13 members, 12 of whom are independent. Dr. Drake, currently the president of the University of California system, has prior leadership experience at The Ohio State University and UC Irvine. His extensive background in medicine and academia is expected to enhance Amgen's innovation efforts in treating serious illnesses.
