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.
News about Amgen Inc. (AMGN) centers on its biotechnology medicines, clinical milestones, corporate transactions and investor communications. The company describes itself as discovering, developing, manufacturing and delivering medicines for cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases, and its news flow reflects activity across these therapeutic areas.
Investors following AMGN news can see updates on regulatory decisions and clinical data for key products. Recent announcements include U.S. Food and Drug Administration approvals and label expansions, such as full approval for IMDELLTRA (tarlatamab-dlle) in extensive stage small cell lung cancer after progression on platinum-based chemotherapy, and approval of UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis who are anti-acetylcholine receptor and anti-MuSK antibody positive. Amgen has also reported landmark cardiovascular outcomes data for Repatha (evolocumab) from the VESALIUS-CV trial.
Corporate development and pipeline news are another focus. Amgen has announced the acquisition of Dark Blue Therapeutics, a biotechnology company developing targeted protein degraders for oncology, adding an investigational MLLT1/3-targeting molecule for acute myeloid leukemia to its portfolio. The company also issues releases on capital allocation decisions, such as dividend declarations, and on participation in major healthcare investment conferences where management discusses business developments.
This AMGN news page allows readers to track company press releases and related coverage, including clinical trial readouts, FDA decisions, acquisitions, pricing and access initiatives, and presentations at scientific and investor meetings. Users interested in biotechnology, oncology innovation, cardiovascular outcomes and large-cap healthcare equities can monitor these updates as part of their ongoing research on Amgen stock.
Amgen (NASDAQ:AMGN) has received FDA approval for LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for treating adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). The approval is based on the Phase 3 CodeBreaK 300 study results.
The study showed that LUMAKRAS (960 mg daily) plus Vectibix demonstrated a median progression-free survival of 5.6 months compared to 2 months with standard care, and an overall response rate of 26% versus 0%. The KRAS G12C mutation occurs in approximately 3-5% of colorectal cancers.
The most common adverse reactions (≥20%) include rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%), and musculoskeletal pain (21%).
Amgen (NASDAQ:AMGN) has announced its participation in the 2025 J.P. Morgan Healthcare Conference. The presentation is scheduled for Monday, January 13, 2025, at 3:00 p.m. PT, featuring Robert A. Bradway, chairman and chief executive officer of Amgen.
The event will be accessible through a live webcast simultaneously available to investors, news media, and the general public. The presentation can be accessed through Amgen's website (www.amgen.com) under the Investors section, along with other selected management presentations from investor and medical conferences. The webcast recording will remain available for replay for a minimum of 90 days following the event.
Asher Biotherapeutics has entered into a clinical trial collaboration and supply agreement with Amgen (NASDAQ:AMGN) to evaluate the combination of etakafusp alfa (AB248) with IMDELLTRA® (tarlatamab) in patients with extensive-stage small cell lung cancer (ES-SCLC).
The collaboration will focus on testing Asher Bio's CD8+ T cell targeted interleukin-2 immunotherapy alongside Amgen's DLL3-targeting Bispecific T-cell Engager therapy. Amgen will sponsor and conduct a global Phase 1b study to evaluate the safety and early efficacy of the combination therapy. Asher Bio will maintain full ownership of etakafusp alfa and provide it to Amgen at no cost.
Amgen (NASDAQ:AMGN) has announced its quarterly dividend for the first quarter of 2025. The company's Board of Directors has declared a dividend of $2.38 per share. Shareholders who are recorded as stockholders by the close of business on February 14, 2025, will receive the dividend payment on March 7, 2025.
Amgen's BLINCYTO (blinatumomab) has shown significant improvement in disease-free survival when added to chemotherapy for newly diagnosed pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL). In a Phase 3 study, the three-year disease-free survival rate was 96.0% for patients receiving BLINCYTO plus chemotherapy, compared to 87.9% for chemotherapy alone, representing a 61% reduction in disease relapse risk.
The study met its primary endpoint early, leading to early termination of randomization due to clear benefits. For standard-risk average patients, three-year survival was 97.5% with BLINCYTO versus 90.2% with chemotherapy alone. For high-risk patients, rates were 94.1% versus 84.8%. Safety results aligned with BLINCYTO's known profile, showing minimal severe side effects.
Amgen (NASDAQ: AMGN) has announced a $1 billion expansion to establish a second drug substance manufacturing facility in Holly Springs, North Carolina. This investment builds upon a previous $550 million commitment, bringing the total planned investment to over $1.5 billion.
The expansion will create 370 new jobs in the region and incorporate cutting-edge technologies and sustainable practices. The new facility, alongside the existing one, will strengthen Amgen's global biomanufacturing network and support the company's ability to meet growing demand for its innovative therapies.
Amgen (NASDAQ:AMGN) has announced its participation in Citi's 2024 Global Healthcare Conference on Thursday, Dec. 5, 2024, at 9:30 a.m. ET. The company will be represented by three executive leaders: Peter Griffith (EVP and CFO), Jay Bradner (EVP of R&D and CSO), and Susan Sweeney (EVP of Obesity and Related Conditions), who will engage in a fireside chat.
The presentation will be webcast live and made accessible to investors, media, and the public through Amgen's website. The webcast recording will remain available for replay on www.amgen.com under the Investors section for at least 90 days following the event.
Amgen (NASDAQ:AMGN) has announced its participation in the 7th Annual Evercore HealthCONx Conference on December 4, 2024, at 10:00 a.m. ET. Three executive leaders will participate in a fireside chat: Peter Griffith (EVP and CFO), Jay Bradner (EVP of Research and Development, CSO), and Susan Sweeney (EVP of Obesity and Related Conditions).
The presentation will be accessible through a live webcast on Amgen's website (www.amgen.com) under the Investors section. The webcast will remain available for replay for at least 90 days following the event.
Amgen (NASDAQ:AMGN) reported positive 52-week Phase 2 study results for MariTide, a monthly or less frequent subcutaneous treatment for obesity. The drug achieved ~20% average weight loss in people with obesity/overweight without Type 2 diabetes, and ~17% weight loss in those with Type 2 diabetes, alongside a 2.2 percentage point reduction in HbA1c. No weight loss plateau was observed, suggesting potential for further weight reduction. The treatment showed improvements in cardiometabolic parameters and had manageable gastrointestinal side effects. The discontinuation rate in dose escalation arms was ~11%. Amgen announced the initiation of MARITIME, a Phase 3 program for obesity and related conditions.
Amgen (NASDAQ:AMGN) announced a webcast scheduled for November 26, 2024, at 5 a.m. PT to discuss the results of their 52-week Phase 2 study of MariTide (maridebart cafraglutide, formerly AMG 133) and its development program progress. The presentation will feature CEO Robert A. Bradway and other senior management team members. The webcast will be accessible to investors, media, and the public through Amgen's website, with replay available for at least 90 days after the event.