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. (AMGN) is a global biotechnology leader pioneering innovative therapies for serious illnesses. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's latest developments, regulatory milestones, and strategic initiatives.
Track critical updates across Amgen's core therapeutic areas including oncology treatments, inflammatory disease therapies, and rare disease solutions. Our curated feed includes earnings reports, clinical trial data, partnership announcements, and manufacturing updates - all sourced directly from official channels.
Key resources include timely coverage of FDA decisions, research breakthroughs in biologics and biosimilars, and analysis of market-moving events. Bookmark this page for structured access to Amgen's evolving pipeline and business strategies without promotional bias.
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.
Amgen will report its first quarter 2024 financial results on May 2, 2024, followed by a conference call with the investment community. The webcast will be available on their website for replay for at least 90 days after the event.
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