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 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.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) received a $50 million milestone payment from Royalty Pharma plc for completing enrollment in the Phase 3 OCEAN(a) - Outcomes Trial of olpasiran, being conducted by Amgen. Arrowhead stands to earn up to an additional $375 million from Amgen and $110 million from Royalty Pharma in milestone payments related to olpasiran. The rapid enrollment in the trial reflects the interest in olpasiran, developed using Arrowhead's TRiMTM technology. With three Phase 3 programs in progress, including plozasiran, Arrowhead continues to advance RNA interference therapies.
Amgen reported strong financial results for the first quarter of 2024, with total revenues increasing by 22% to $7.4 billion compared to the same quarter in 2023. Product sales saw significant growth, driven by key products such as Repatha, TEZSPIRE, and EVENITY. The company's acquisition of Horizon Therapeutics contributed $914 million in sales. However, Amgen experienced a GAAP loss per share of $0.21 due to lower earnings and higher expenses. Non-GAAP EPS also decreased slightly. Despite challenges, the company generated $0.5 billion in free cash flow and provided guidance for the full year 2024.
Amgen presented new respiratory data at the ATS 2024 International Conference, including results from the Tezspire Phase 2a COURSE COPD study, AMG104/AZD8630 Phase 1 asthma study, and TAVNEOS avacopan data in adults with severe active ANCA-associated vasculitis. The company's commitment to developing treatments for respiratory diseases with options was highlighted.
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