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) has announced its third quarter dividend for 2024. The company's Board of Directors has declared a dividend of $2.25 per share, which will be paid on September 6, 2024. This dividend is available to all stockholders of record as of the close of business on August 16, 2024. This announcement demonstrates Amgen's commitment to providing regular returns to its shareholders, which may be viewed positively by investors looking for stable income-generating stocks in the biotechnology sector.
Amgen (NASDAQ:AMGN) has announced that it will report its second quarter 2024 financial results on Tuesday, August 6, 2024, after the close of U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET. Robert A. Bradway, chairman and CEO, along with other senior management team members, will participate in the call.
The conference call will be broadcast live over the internet and will be accessible to news media, investors, and the general public. The webcast can be found on Amgen's website under the Investors section. The webcast will be archived and available for replay for at least 90 days after the event.
Amgen (NASDAQ: AMGN) announced FDA approval for BLINCYTO® (blinatumomab) for treating CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. This marks BLINCYTO's third indication.
Data from the Phase 3 E1910 trial showed BLINCYTO, added to chemotherapy, reduces the risk of death by 58% and improves overall survival (OS). The 3-year OS was 84.8% with BLINCYTO plus chemotherapy compared to 69% with chemotherapy alone. The study had a median follow-up of 4.5 years.
This approval provides a new standard of care for B-ALL patients, offering a more effective treatment option than chemotherapy alone.
Amgen (NASDAQ:AMGN) presented several significant findings at the European Alliance of Associations for Rheumatology's (EULAR) 2024 Congress. The event, held from June 12-15 in Vienna, showcased 27 abstracts from Amgen-sponsored and partner-led studies. Key highlights include improvements in biomarkers for Sjögren's disease with dazodalibep, positive outcomes for uncontrolled gout with KRYSTEXXA® (pegloticase) combined with methotrexate, and long-term data from the FOREMOST study of Otezla® (apremilast) in early oligoarticular psoriatic arthritis. Additional studies covered topics like psoriatic arthritis, osteoporosis, and ANCA-associated vasculitis. This data underscores Amgen's commitment to advancing treatment options for inflammatory and rheumatic diseases.
Amgen (NASDAQ: AMGN) will be presenting at the Goldman Sachs 45th Annual Global Healthcare Conference. The presentation is scheduled for June 10, 2024, at 9:20 a.m. ET. Key speakers include Peter Griffith, executive vice president and CFO, and Jay Bradner, executive vice president of R&D and chief scientific officer. The presentation will be webcast live and archived for replay on Amgen's website for at least 90 days. This offers insights into Amgen's ongoing business developments and is accessible to media, investors, and the general public.
Amgen announced positive results from a Phase 3 registrational trial evaluating UPLIZNA® (inebilizumab-cdon) for treating Immunoglobulin G4-related disease (IgG4-RD). The trial, conducted at 80 sites across 22 countries, showed a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo, meeting all primary and key secondary endpoints. No new safety signals were identified, and the overall safety profile was consistent with known data. The results mark a significant milestone in treating IgG4-RD, which currently has no approved therapy. Amgen plans to file for approval in the U.S. and other key markets.
Amgen (NASDAQ: AMGN) will present at the Jefferies Global Healthcare Conference on June 6, 2024, at 9:00 a.m. ET. Key speakers include Peter Griffith, Executive Vice President and CFO, and Ian Thompson, Senior Vice President of U.S. Business Operations. The presentation will be webcast live and accessible to the public, including investors and media, on Amgen's website. The webcast will also be archived for 90 days for replay.
Amgen will present significant research findings from its oncology portfolio at the ASCO 2024 Annual Meeting. Highlights include data from the newly FDA-approved IMDELLTRA™ (tarlatamab-dlle) and overall survival results from the Phase 3 LUMAKRAS® (sotorasib) plus Vectibix® (panitumumab) study in metastatic colorectal cancer. The company showcases 17 abstracts, emphasizing cutting-edge advancements in treating difficult cancers. Key presentations include Phase 2 DeLLphi-301 study results in small cell lung cancer, Phase 1b DeLLpro-300 study in neuroendocrine prostate cancer, and updated Phase 1b CodeBreaK 101 trial data in advanced non-small cell lung cancer.
On May 19, 2024, Amgen and AstraZeneca announced results from the Phase 2a COURSE trial evaluating Tezspire® (tezepelumab-ekko) for COPD. Although the primary endpoint showed a non-significant 17% reduction in COPD exacerbations compared to placebo, notable improvements were observed in specific patient subgroups. Patients with blood eosinophil counts (BEC) ≥150 cells/μL experienced a 37% reduction in exacerbations, while those with BEC ≥300 cells/μL saw a 46% reduction. Tezspire also improved lung function and quality of life. Safety profiles were consistent with previous findings for severe asthma.
Amgen (NASDAQ: AMGN) announced that the FDA has approved IMDELLTRA™ (tarlatamab-dlle), a unique Bispecific T-cell Engager (BiTE®) therapy, for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy. This approval was based on data from the Phase 2 DeLLphi-301 trial, which showed an objective response rate (ORR) of 40%, a median duration of response (DoR) of 9.7 months, and a median overall survival (mOS) of 14.3 months. Amgen will host an investor call on May 20, 2024, to discuss the approval. The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity among other adverse reactions.