Amgen Inc Stock Price, News & Analysis

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.

Amgen (NASDAQ:AMGN) announced the presentation of four cardiovascular research abstracts at the American College of Cardiology's 70th Annual Scientific Session & Expo (ACC.21), taking place May 15-17, 2021. Key highlights include final data from the Repatha® (evolocumab) trial for HIV patients with high cholesterol, confirming its safety and efficacy. The PROFICIO program, encompassing 50 trials and over 47,000 patients, supports the treatment's impact on cardiovascular disease. With over one million patients treated with Repatha globally, Amgen is committed to advancing cardiovascular treatment.

Amgen announced that AstraZeneca submitted a Biologics License Application (BLA) for tezepelumab to the FDA. This potential first-in-class treatment aims to address severe asthma, with clinical trials indicating a significant reduction in asthma exacerbations. The pivotal NAVIGATOR Phase 3 trial showed tezepelumab's ability to reduce exacerbation rates regardless of baseline eosinophil counts, making it unique among biologics. Tezepelumab targets thymic stromal lymphopoietin, key in asthma inflammation.

This submission is a step towards offering a transformative treatment for severe asthma patients.

Amgen will present at the 2021 Bank of America Merrill Lynch Virtual Healthcare Conference on May 11, 2021, at 11:00 a.m. ET. Key executives, including David M. Reese, M.D., Murdo Gordon, and Peter H. Griffith, will deliver presentations. The conference will be accessible via a live audio webcast for media, investors, and the public on Amgen's website. An archived version will be available for at least 90 days. Amgen focuses on developing innovative therapies for serious illnesses, leveraging human genetics since 1980.

Amgen announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for Otezla® (apremilast) aimed at treating adults with mild-to-moderate plaque psoriasis. The PDUFA action date is set for December 19, 2021. Positive results from the Phase 3 ADVANCE trial indicate that Otezla significantly improved psoriasis symptoms compared to placebo. The treatment has a consistent safety profile, with common adverse events including diarrhea and headache. Since its 2014 approval, over 250,000 patients have been treated with Otezla in the U.S.

Amgen announced a collaboration with the FDA to conduct a multi-center clinical trial comparing the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower dose of 240 mg. This trial, part of the ongoing development program, is expected to yield results by late 2022. Amgen states there will be no impact on the ongoing priority review timelines for LUMAKRAS™. Forward-looking statements caution that actual results may differ due to numerous risks and uncertainties, particularly regarding clinical trials and regulatory approvals.

Amgen reported Q1 2021 financial results with total revenues of $5.9 billion, a 4% decline from Q1 2020, attributed to lower net selling prices but partially offset by volume growth. GAAP EPS decreased 8% to $2.83, and non-GAAP EPS fell 12% to $3.70. Operating income also saw a decline of 10%. The company reaffirmed its total revenue guidance for 2021 at $25.8-$26.6 billion, but revised GAAP EPS guidance down to $9.11-$10.71 from $12.12-$13.17. Despite challenges from COVID-19, Amgen is optimistic about future growth, especially in newer products.