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. (NASDAQ: AMGN) is a leading American multinational biopharmaceutical company, established in 1980 and headquartered in Thousand Oaks, California. As one of the largest independent biotechnology companies globally, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on areas of high unmet medical need and leverages its expertise in advanced human genetics to develop solutions that dramatically improve people's lives.
Amgen's portfolio includes a range of flagship drugs such as red blood cell boosters Epogen and Aranesp, immune system enhancers Neupogen and Neulasta, and treatments for inflammatory diseases like Enbrel and Otezla. Additionally, the company has a strong presence in the oncology sector with products like Vectibix, Prolia, Evenity, and Kyprolis. Notably, the acquisition of Onyx Pharmaceuticals bolstered Amgen's oncology portfolio.
Recent launches include innovative therapies such as Repatha for cholesterol management, Aimovig for migraines, Lumakras for lung cancer, and Tezspire for asthma. In 2023, Amgen's acquisition of Horizon Therapeutics introduced several rare-disease drugs to its portfolio, including Tepezza for thyroid eye disease. Amgen also continues to expand its biosimilar portfolio, reinforcing its commitment to making advanced treatments more accessible.
Amgen's financial health is robust, with significant growth in revenues and product sales. The company's strategic partnerships and acquisitions have continually strengthened its market position. For instance, the recent Phase 3 SPROUT study demonstrated the efficacy and safety of Otezla in pediatric patients, highlighting Amgen's ongoing commitment to addressing various health needs. Furthermore, the company’s dedication to innovation is evident from its extensive pipeline of investigational drugs targeting various conditions.
Amgen has been acknowledged for its workplace culture and environmental initiatives, being named one of
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.
Amgen (NASDAQ: AMGN) will host a conference call for investors on May 20, 2024, at 1:00 p.m. PT, following the presentation of new data on TEZSPIRE® for chronic obstructive pulmonary disease (COPD) at the American Thoracic Society (ATS) International Conference. The presentation will be held on May 19-20, 2024, and also include updates on Amgen's inflammation portfolio. Jay Bradner, EVP of R&D and Chief Scientific Officer, along with other team members, will participate. The webcast will be accessible online, including media, investors, and the public, and will be archived for 90 days on Amgen's website.
Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference on May 14, 2024. Key executives will discuss business developments, and the webcast will be available on the company's website for replay.
