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.
Amgen (NASDAQ: AMGN) announced that the FDA granted full approval to IMDELLTRA (tarlatamab-dlle) on Nov 19, 2025 for adult patients with extensive stage small cell lung cancer (ES-SCLC) with progression after platinum-based chemotherapy. The decision converts prior accelerated approval based on the global Phase 3 DeLLphi-304 trial, which showed a 40% reduction in risk of death versus standard chemotherapy (median overall survival 13.6 vs. 8.3 months; HR 0.60; P < 0.001).
The NCCN Guidelines were updated to list tarlatamab as the only Category 1 preferred option in this setting. Safety in DeLLphi-304 was consistent with known profile: fewer Grade ≥3 adverse events versus chemotherapy (54% vs. 80%); common IMDELLTRA toxicities included neutropenia (4%), lymphopenia (4%), and primarily low-grade cytokine release syndrome.
Amgen (NASDAQ:AMGN) reported Phase 3 VESALIUS-CV results showing Repatha (evolocumab) reduced first major adverse cardiovascular events by 25% (3‑P MACE) in >12,000 high‑risk adults without prior heart attack or stroke when added to LDL‑lowering therapy.
The trial also showed a 36% reduction in heart attack, a 19% reduction in 4‑P MACE, and median achieved LDL‑C of 45 mg/dL versus 109 mg/dL for placebo. No new safety signals were identified. Results presented at AHA 2025 and published in NEJM.
Amgen (NASDAQ:AMGN) reported Q3 2025 revenues of $9.6 billion, up 12% year-over-year, with product sales also up 12% driven by 14% volume growth and a 4% decline in net selling price. GAAP EPS rose 14% to $5.93; non-GAAP EPS was $5.64. GAAP operating margin improved to 27.6% while non-GAAP margin fell to 47.1%. The company generated $4.2 billion free cash flow in Q3 and retired $1.6 billion of debt in the quarter ($6.0 billion YTD). Management reiterated full-year 2025 guidance: revenues $35.8B–$36.6B, GAAP EPS $13.76–$14.60, non-GAAP EPS $20.60–$21.40.
Amgen (NASDAQ:AMGN) announced its 2025 fourth-quarter dividend: a cash dividend of $2.38 per share. The Board declared the dividend on Oct 31, 2025, with payment on December 12, 2025 to shareholders of record as of the close of business on November 21, 2025.
Amgen (NASDAQ:AMGN) will present late-breaking results from the Phase 3 VESALIUS-CV trial of Repatha (evolocumab) at the American Heart Association Scientific Sessions on November 8, 2025 at 9:10 a.m. CST. The trial met its dual primary endpoints, showing Repatha significantly reduced major adverse cardiovascular events (MACE) in high-risk patients without prior heart attack or stroke, making it the first PCSK9 inhibitor to show this benefit in that population.
Amgen will also present large real-world studies: VESALIUS-REAL (observational, >1.1 million patients across 11 countries) on lipid management and MACE incidence, and REPATHA-CE, the largest real-world study of Repatha showing a reported four-year risk reduction versus untreated patients. Multiple additional abstracts and session times span November 8–10, 2025.
Exxon Mobil (NYSE: XOM) announced that Gregory C. Garland has been elected to its board of directors, effective November 3, 2025. Mr. Garland brings decades of executive experience in energy, including roles as Chair and CEO of Phillips 66 from 2012–2022, Executive Chair 2022–2024, and President and CEO of Chevron Phillips Chemical Company 2008–2010. ExxonMobil leadership highlighted his industry expertise, global perspective, and collaborative reputation as reasons for the appointment. The company said his experience will support efforts to develop advantaged assets, deliver new projects, lower costs, and prioritize long-term shareholder returns.
Amgen (NASDAQ:AMGN) will report Q3 2025 financial results on Tuesday, November 4, 2025 after U.S. market close, followed by a conference call at 4:30 p.m. ET.
Amgen CEO Robert A. Bradway and senior management will participate. Live audio will be webcast and available to media, investors, and the public on Amgen's Investor Relations Events Calendar at www.amgen.com. Webcast links and presentation times are listed on the events calendar. The webcast will be archived and available for replay for at least 90 days after the event.
Amgen (NASDAQ:AMGN) and AstraZeneca announced FDA approval on October 17, 2025 of TEZSPIRE (tezepelumab-ekko) for add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. TEZSPIRE is the first biologic for CRSwNP that targets thymic stromal lymphopoietin (TSLP). Approval was supported by the WAYPOINT Phase III trial, which showed a statistically significant reduction in nasal polyp severity, near-elimination of the need for surgery, and significant reduction in systemic corticosteroid use versus placebo. Safety was described as generally consistent with the drug's established severe asthma profile. Regulatory applications are under review in Europe, China, Japan and other countries.
Amgen (NASDAQ: AMGN) launched AmgenNow, a U.S. direct-to-patient program making Repatha (evolocumab) available at a monthly price of $239, nearly 60% below the current U.S. list price, starting Oct 6, 2025. The offer is open to all patients, including uninsured, high-deductible plan holders, cash payers, and participants in Medicare and Medicaid.
Amgen said Repatha has helped over 5 million patients and cited VESALIUS-CV Phase 3 results showing reduced major adverse cardiovascular events; patients using AmgenNow will not face insurer step therapy or prior authorization. Amgen described $239 as the lowest Repatha price among G-7 countries and plans TrumpRx availability.
Amgen (NASDAQ: AMGN) corrected a typo and announced AmgenNow, a U.S. direct-to-patient program launching for Repatha (evolocumab) on Oct 6, 2025. Repatha will be offered through AmgenNow at a monthly price of $239, described as nearly 60% below the current U.S. list price and the lowest among G-7 countries.
The program is open to all patients including the uninsured, those with high-deductible plans, cash payers, and participants in Medicare and Medicaid; enrolled patients are not subject to insurer step therapy or prior authorization. The announcement cites VESALIUS-CV Phase 3 results showing Repatha reduced major adverse cardiovascular events and notes Repatha has helped more than 5 million patients.