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. reports developments across its biotechnology medicines business, including discovery, development, manufacturing and delivery of human therapeutics. Company updates center on a portfolio and pipeline spanning cancer, inflammatory conditions, rare diseases, heart disease, obesity and obesity-related conditions, with named products and programs such as TEPEZZA, Repatha and IMDELLTRA appearing in clinical and commercial announcements.
Recurring news also covers quarterly financial results, non-GAAP performance measures, manufacturing network investments, supply-chain capacity, research collaborations, medical and investor conference presentations, and executive or organizational changes tied to the integration of biology, technology, artificial intelligence and data across Amgen's operations.
Amgen (NASDAQ:AMGN) declared a $1.76 per share dividend for Q2 2021, set to be paid on June 8, 2021, to stockholders of record by May 17, 2021. The company highlights its commitment to developing innovative therapies focusing on high unmet medical needs. Amgen's legacy in biotechnology since 1980 has positioned it among leading independent biotech firms, striving for improved health outcomes globally.
Amgen announced that data from a Phase 3 study published in JAMA highlights the efficacy of BLINCYTO (blinatumomab) in pediatric patients with high-risk B-cell precursor acute lymphoblastic leukemia (B-ALL). After a median follow-up of 22.4 months, 69% of patients treated with BLINCYTO were alive and event-free, compared to 43% with chemotherapy. The 36-month overall survival rate was 81.1% for BLINCYTO versus 55.8% for chemotherapy. Serious adverse events were significantly lower in the BLINCYTO group (24.1% vs. 43.1%). These results suggest BLINCYTO may be a new standard of care for this aggressive disease.
Amgen and AstraZeneca announced positive results from the NAVIGATOR Phase 3 trial for tezepelumab as a potential first-in-class treatment for severe asthma. The trial demonstrated a 56% reduction in the annualized asthma exacerbation rate (AAER) when added to standard care over 52 weeks compared to placebo (p<0.001). Key secondary endpoints also showed significant improvements in lung function and quality of life. There were no significant safety differences between tezepelumab and placebo. Tezepelumab is a promising option for patients with severe asthma, regardless of eosinophil count.
Amgen (NASDAQ:AMGN) will participate in the Cowen 41st Annual Virtual Healthcare Conference on March 4, 2021, at 12:50 p.m. ET. Presenters include Murdo Gordon, EVP of Global Commercial Operations, and Peter H. Griffith, CFO. The presentation will be accessible live via Amgen's website and available as a replay for at least 90 days. Amgen is dedicated to developing innovative therapies for serious illnesses through advanced genetics and biotechnology. The company aims to address high unmet medical needs and improve health outcomes globally.
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.