Amgen Inc Stock Price, News & Analysis

Amgen reported Q3 2020 financial results with total revenues of $6.4 billion, up 12% year-over-year, driven by significant volume growth despite challenges due to COVID-19. Product sales also rose 12%, with notable increases in Otezla® and Repatha®. GAAP EPS increased 5% to $3.43, while non-GAAP EPS saw a 19% rise to $4.37. Free cash flow remained stable at $3.2 billion. Amgen narrowed its total revenue guidance for 2020 to $25.1-$25.5 billion and revised EPS guidance upwards.

Amgen (NASDAQ:AMGN) will release its third quarter financial results on October 28, 2020, after U.S. market close. Following this, a conference call will occur at 2:00 p.m. PT, featuring CEO Robert A. Bradway and senior management. The call will be accessible via live audio on Amgen's website, where it will also be archived for 90 days. Amgen continues to focus on innovative therapeutics, addressing high unmet medical needs, and has built a strong pipeline since its inception in 1980.

Amgen has completed discussions with the FDA regarding its Phase 2 trial for efavaleukin alfa, aimed at treating Systemic Lupus Erythematosus (SLE). This initiative is part of the FDA's Complex Innovative Trial Designs Pilot Program, focusing on modernizing drug development. The adaptive clinical trial design is expected to enhance the development of new therapies for SLE, addressing the significant unmet medical need in this area. The collaboration signals a commitment to improve efficiency and innovation in clinical trials.

Amgen (NASDAQ:AMGN) declared a $1.60 per share dividend for Q4 2020, payable on December 8, 2020, to shareholders recorded by November 16, 2020. This follows Amgen's commitment to improve health outcomes through innovative therapies, supported by a strong pipeline and advanced human genetics. The company, a pioneer in biotechnology since 1980, focuses on serious illnesses and has reached millions globally.

Amgen announced positive Phase 2 results for sotorasib, a KRAS G12C inhibitor, in treating advanced non-small cell lung cancer (NSCLC) in patients with prior treatment failures. The study involved 126 patients, showing an objective response rate consistent with past Phase 1 data and promising efficacy measures. More than half of responders remained on treatment at data cutoff. Amgen plans to discuss results with regulatory agencies and is advancing its development program, which includes a Phase 3 study, CodeBreaK 200, comparing sotorasib to docetaxel.

Amgen announced positive results for Aimovig (erenumab-aooe) at the Migraine Trust Virtual Symposium, showcasing a five-year study on its safety and efficacy in treating episodic migraine. The Phase 2 study involved 383 patients, with 216 completing the open-label phase. Results indicated a reduction of 5.3 monthly migraine days and 4.4 days less use of acute migraine medication. No increase in adverse events was recorded, affirming Aimovig's safety profile. This long-term data further establishes Aimovig as a leading preventive treatment for migraines.

Amgen announces updated data from the CodeBreaK 100 clinical study on sotorasib, a KRAS^G12C inhibitor, published in the New England Journal of Medicine. The study evaluated 129 patients across various advanced solid tumors. In 34 heavily pretreated patients with advanced non-small cell lung cancer (NSCLC), sotorasib showed an objective response rate of 35.3% and a disease control rate of 91.2%. Safety data demonstrated tolerability, with no dose-limiting toxicities. Upcoming Phase 2 results are highly anticipated among investors and the medical community.

Amgen will host two webcast investor calls during the ESMO 2020 Virtual Congress. The first call is scheduled for September 20, 2020, at 11:00 a.m. PDT, where Dr. David M. Reese will discuss Phase 1 data on the KRAS^G12C inhibitor, sotorasib (AMG 510). The second call is on September 21, at 1:00 p.m. PDT, focusing on a bispecific T-cell engager targeting PSMA. These webcasts will be available live and archived on Amgen's website for at least 90 days, making it accessible to investors and the public.

Amgen (NASDAQ:AMGN) announced it will present data from its oncology pipeline during the ESMO Virtual Congress 2020, taking place from Sept. 19-21, 2020. Key presentations include Phase 1 clinical results for AMG 510, a KRAS^G12C inhibitor for non-small cell lung cancer, and AMG 160, a bispecific T cell engager targeting prostate cancer. Highlights include a presentation on clinical benefit durability for AMG 510 on Sept. 20 and AMG 160 on Sept. 21. The company will also hold webcast calls on Sept. 20 and 21 to discuss Phase 1 data with investors.