Amgen Inc Stock Price, News & Analysis

Amgen (NASDAQ:AMGN) has partnered with the International Federation of Psoriasis Associations to launch the UPLIFT Innovation Challenge, aimed at improving health outcomes for individuals with psoriatic disease. Applicants can submit innovative ideas by August 30, 2021, for a chance to receive a grant of $25,000 USD. This initiative responds to findings from the 2020 UPLIFT survey, which highlighted significant gaps in treatment and patient-provider communication. Notably, it found only 50% of those with psoriatic arthritis saw a healthcare provider within the past year.

Amgen (NASDAQ:AMGN) announced that the FDA has accepted its Biologics License Application for tezepelumab, granting it Priority Review for asthma treatment. This decision was based on the PATHFINDER clinical trial results, particularly the NAVIGATOR Phase 3 trial, where tezepelumab showed superiority over placebo for patients with uncontrolled asthma. The FDA aims to make a decision by Q1 2022. This innovative treatment addresses a significant unmet medical need, as many patients do not respond well to current therapies.

Amgen (NASDAQ:AMGN) has received marketing approval from the Japanese Ministry of Health, Labour and Welfare for Aimovig® (erenumab), the first treatment in Japan targeting the calcitonin gene-related peptide receptor for migraine prevention in adults. This marks Amgen K.K.'s first independent submission and approval. Aimovig demonstrated a significant reduction in monthly migraine days in clinical trials. With approximately 8.4 million migraine sufferers in Japan, this approval aims to increase access to effective migraine treatment.

deCODE genetics, a subsidiary of Amgen, has developed a blood-based predictor to estimate time to all-cause death, outperforming traditional risk factors. The research analyzed nearly 5,000 protein measurements from 22,913 Icelanders, revealing a significant correlation between protein profiles and mortality. The predictor effectively identifies individuals at both high and low risk of death within a decade. Key findings include the role of growth/differentiation factor 15 (GDF15) in predicting mortality.

Amgen has launched the INSIDE LOOK campaign featuring Hollywood makeup artist Allan Avendaño to raise awareness about plaque psoriasis, a chronic autoimmune condition affecting over 8 million Americans. Avendaño shares his personal journey with the disease, emphasizing the importance of understanding and treating the condition from within. The campaign includes a makeup tutorial for Otezla patients and highlights that Otezla can help achieve up to 75% clearer skin in four months. Dermatologist Dr. Jennifer Soung discusses treatment options and urges individuals to consult healthcare providers for personalized treatment plans.

Amgen (NASDAQ:AMGN) will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, 2021, at 4:40 p.m. ET. Key executives, including David M. Reese and Peter H. Griffith, will speak at this event. A live audio broadcast of the presentation will be available for the public, and the replay will be accessible for 90 days post-event. Amgen, a leader in biotechnology since 1980, focuses on innovative therapeutics for serious illnesses, leveraging advanced human genetics to improve health outcomes.

Amgen presented data from the Phase 2 CodeBreaK 100 clinical study at the 2021 ASCO Annual Meeting, demonstrating that LUMAKRAS (sotorasib) provides a median overall survival of 12.5 months in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The study included 124 evaluable patients, showing an objective response rate of 37.1% and a disease control rate of 80.6%. LUMAKRAS received FDA approval on May 28, 2021, under accelerated approval, with ongoing trials expected to confirm clinical benefits.

Amgen announced updated results from the Phase 2 FIGHT trial for bemarituzumab, showing enhanced median overall survival (OS) of 19.2 months with the drug combined with chemotherapy compared to 13.5 months for chemotherapy alone in 155 patients. Notably, patients with over 10% FGFR2b-positive tumors had an OS of 25.4 months versus 11.1 months. Corneal adverse events were more common in the treatment arm (67.1% vs. 10.4%). These results were shared at the ASCO Annual Meeting, reinforcing the drug's potential as a first-in-class therapy for advanced gastric and gastroesophageal cancers, with plans for Phase 3 development.

Amgen (NASDAQ: AMGN) will host a webcast call for investors on June 4, 2021, at 4:00 p.m. ET, during the ASCO Annual Meeting. Dr. David M. Reese and the clinical development team will discuss key clinical data on the FDA-approved KRAS inhibitor LUMAKRAS™ (sotorasib), plus anti-FGFR2b antibody bemarituzumab and the bispecific T-cell engager tarlatamab. The live audio will be accessible to media, investors, and the public via Amgen's website. The recording will remain available for 90 days post-event.