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 announced a $900 million expansion of its Ohio manufacturing facility, which will create 350 new jobs, bringing the total employment to 750 positions and total investment in Central Ohio to over $1.4 billion.
The expansion builds upon Amgen's initial entry into Ohio in June 2021, when it established a state-of-the-art biomanufacturing facility that created 400 jobs. This investment is part of Amgen's broader U.S. manufacturing strategy, which includes nearly $5 billion in direct capital expenditures since 2017, generating approximately $12 billion in additional downstream output to the U.S. economy.
The Ohio expansion enhances Amgen's global biomanufacturing network and follows the company's recent announcement of a $1 billion investment for a second manufacturing plant in Holly Springs, NC.
Amgen (NASDAQ:AMGN) announced significant breakthrough in their Phase 3 DeLLphi-304 clinical trial for IMDELLTRA® (tarlatamab-dlle), a treatment for small cell lung cancer (SCLC). The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard-of-care chemotherapy.
The global Phase 3 trial focused on patients who progressed on or after a single line of platinum-based chemotherapy. The study compared IMDELLTRA against local standard-of-care treatments including topotecan, lurbinectedin, and amrubicin depending on the region. The safety profile remained consistent with previously known data.
Dr. Jay Bradner, Executive VP of Research and Development at Amgen, emphasized the overwhelming clinical benefit for patients with this aggressive malignancy. Detailed trial results are scheduled for presentation at an upcoming medical congress.
Amgen (NASDAQ:AMGN) has received FDA approval for UPLIZNA as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a chronic immune-mediated inflammatory condition affecting multiple organs. The FDA granted Breakthrough Therapy Designation for this indication.
The approval is supported by the MITIGATE trial, which demonstrated an 87% reduction in flare risk versus placebo. UPLIZNA, a CD19+ B-Cell targeted therapy, showed effectiveness in achieving corticosteroid-free, flare-free complete remission.
This marks UPLIZNA's second FDA-approved indication, following its June 2020 approval for NMOSD treatment. Amgen is also pursuing regulatory approval for generalized myasthenia gravis (gMG), with submission planned for H1 2025.
Amgen (NASDAQ:AMGN) announced positive 52-week data from the Phase 3 MINT trial for UPLIZNA® in treating generalized myasthenia gravis (gMG). The trial demonstrated significant improvement in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG using just two doses yearly after initial loading.
Key findings include:
- 72.3% of AChR+ patients on UPLIZNA achieved ≥3 point improvement in MG-ADL score vs 45.2% for placebo
- Significant change in baseline MG-ADL score (adjusted difference -2.8)
- 69.2% of UPLIZNA patients improved ≥3 points in QMG score vs 41.8% for placebo
The trial was notable as the first Phase 3 study for a biologic incorporating corticosteroid tapering in its protocol. No new safety concerns were identified, with common adverse events including infusion-related reactions, nasopharyngitis, and urinary tract infections. Regulatory filing is expected to complete in H1 2025.
Amgen (NASDAQ: AMGN) and Kyowa Kirin announced positive results from the ROCKET Phase 3 clinical program for rocatinlimab, their investigational therapy for moderate to severe atopic dermatitis. The IGNITE study, involving 769 adults, met all primary and secondary endpoints with statistical significance across two dose strengths.
Key results at week 24 for the higher dose group showed:
- 42.3% of patients achieved EASI-75 (29.5% difference vs placebo)
- 23.6% achieved vIGA-AD score of 0/1 (14.9% difference vs placebo)
- 22.7% achieved rIGA score of 0/1 (14.4% difference vs placebo)
The SHUTTLE study, testing rocatinlimab with topical treatments in 746 adults, also met its endpoints. Common side effects included pyrexia, chills, and headache, with gastrointestinal ulceration events occurring in less than 1% of patients. Additional studies ASCEND, ASTRO, and ORBIT are ongoing to evaluate long-term maintenance and effects in adolescent patients.
Amgen (NASDAQ:AMGN) has announced its quarterly dividend payment for Q2 2025. The company's Board of Directors has declared a dividend of $2.38 per share. The dividend will be distributed on June 6, 2025, to stockholders who are recorded in the company's books as of the close of business on May 16, 2025.
Amgen (NASDAQ:AMGN) and AstraZeneca announced positive results from the Phase 3 WAYPOINT trial for TEZSPIRE® (tezepelumab-ekko) in treating chronic rhinosinusitis with nasal polyps (CRSwNP).
The trial demonstrated significant improvements in key metrics:
- Reduced nasal polyp severity with a Nasal Polyp Score decrease of -2.065
- Improved nasal congestion with a score reduction of -1.028
- Decreased need for nasal polyp surgery by 98%
- Reduced systemic corticosteroid use by 88%
Improvements were observed as early as week two for nasal congestion and week four for polyp score, with effects sustained through week 52. The safety profile aligned with its approved severe asthma indication, with common adverse events including COVID-19, nasopharyngitis, and upper respiratory tract infection.
Amgen (NASDAQ: AMGN) has announced its participation in the 45th Annual TD Cowen Health Care Conference scheduled for March 5, 2025, at 9:10 a.m. ET. Jay Bradner, executive vice president of Research and Development, will engage in a fireside chat during the conference.
The presentation will be accessible through a live webcast available to investors, media, and the general public. The webcast can be accessed on www.amgen.com under the Investors section, along with other management presentations from investor and medical conferences. The webcast recording will remain available for replay for a minimum of 90 days following the event.
Amgen (NASDAQ: AMGN) has announced its participation in Citi's 2025 Virtual Oncology Leadership Summit scheduled for Wednesday, February 19, 2025, at 3:00 p.m. ET. Jean-Charles Soria, senior vice president of oncology within global development at Amgen, will represent the company at the conference.
The presentation will be accessible through a live webcast simultaneously available to investors, news media, and the general public. The webcast can be accessed through Amgen's website (www.amgen.com) under the Investors section, along with other management presentations from investor and medical conferences. The presentation will remain archived and available for replay on the website for a minimum of 90 days following the event.
Amgen (NASDAQ: AMGN) has announced its participation in the 35th Annual Oppenheimer Healthcare Life Sciences Conference scheduled for Wednesday, February 12, 2025, at 11:20 a.m. ET. Narimon Honarpour, senior vice president of global development at Amgen, will represent the company at the conference.
The presentation will be accessible through a live webcast simultaneously available to investors, news media, and the general public. The webcast can be accessed through Amgen's website (www.amgen.com) under the Investors section, along with other management presentations from investor and medical conferences. The presentation will remain archived and available for replay on the website for a minimum of 90 days following the event.