Amgen Inc Stock Price, News & Analysis

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.

Amgen has declared a $1.94 per share dividend for the third quarter of 2022, payable on September 8, 2022. Stockholders on record by August 18, 2022 will receive this dividend. As a leader in biotechnology, Amgen focuses on developing innovative therapeutics for serious illnesses through advanced human genetics. The company’s commitment to health outcomes has made it a significant player in the Dow Jones Industrial Average and Nasdaq-100 index.

Amgen will host a webcast for investors on August 8, 2022, at 12:00 p.m. ET, during the IASLC 2022 World Conference on Lung Cancer. David M. Reese, M.D., will present data on LUMAKRAS® (sotorasib) used alongside immunotherapy and a SHP2 inhibitor for treating non-small cell lung cancer, plus findings on tarlatamab for small cell lung cancer. The webcast will be available for replay for 90 days post-event. More details can be found on Amgen's website.