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 presented new data for its rare disease treatments at ACR 2024, highlighting significant results for UPLIZNA and KRYSTEXXA. The MITIGATE Phase 3 study showed UPLIZNA reduced IgG4-RD flare risk by 87% compared to placebo, with 57.4% of patients achieving flare-free complete remission at Week 52. The AGILE trial demonstrated that KRYSTEXXA with methotrexate administered in 60-minute infusions maintained efficacy, with 67.2% of participants achieving target urate levels. The FDA granted Breakthrough Therapy Designation for UPLIZNA in IgG4-RD, and regulatory filings are underway for both treatments.
Amgen (NASDAQ:AMGN) has released a statement regarding the Phase 1 data of MariTide (maridebart cafraglutide, formerly AMG 133). The company affirms there is no apparent connection between MariTide administration and bone mineral density changes. Amgen maintains that the Phase 1 study results do not indicate any bone safety concerns and do not affect their confidence in MariTide's potential. The company plans to release Phase 2 topline data later this year.
Amgen (NASDAQ:AMGN) has announced its participation in the 2024 UBS Global Healthcare Conference. Peter Griffith, executive vice president and CFO, will represent the company on Wednesday, Nov. 13, 2024, at 10:15 a.m. PT.
The presentation will be accessible through a live webcast available to investors, media, and the public. The webcast can be accessed on Amgen's website under the Investors section and will remain available for replay for at least 90 days following the event.
Amgen and AstraZeneca announced positive top-line results from the Phase 3 WAYPOINT trial of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The trial showed statistically significant and clinically meaningful reductions in both nasal polyp size and nasal congestion compared to placebo. The study evaluated TEZSPIRE's efficacy in adults with severe CRSwNP who remained symptomatic despite standard intranasal corticosteroid treatment. The safety profile was consistent with previous findings.
Amgen (NASDAQ:AMGN) reported strong Q3 2024 financial results with total revenues increasing 23% to $8.5 billion. Product sales grew 24%, driven by 29% volume growth, partially offset by 2% lower net selling price. Ten products delivered double-digit sales growth, including Repatha, TEZSPIRE, and BLINCYTO. The company reported $1.2 billion in rare disease product sales. GAAP EPS increased 62% to $5.22, while Non-GAAP EPS rose 13% to $5.58. Free cash flow generation was $3.3 billion, up from $2.5 billion in Q3 2023. The company updated its full-year 2024 guidance, expecting total revenues between $33.0-33.8 billion.
Amgen (NASDAQ:AMGN) has announced its fourth quarter 2024 dividend payment. The company's Board of Directors has declared a dividend of $2.25 per share. Shareholders who are recorded as stockholders at the close of business on November 18, 2024, will receive the dividend payment on December 9, 2024.
Amgen (NASDAQ:AMGN) has scheduled its third quarter 2024 financial results announcement for Wednesday, October 30, 2024, after U.S. market close. The company will host a conference call at 4:30 p.m. ET featuring Chairman and CEO Robert A. Bradway and senior management. The call will be webcast live and accessible to investors, media, and the public through Amgen's website. The webcast recording will remain available for replay for at least 90 days post-event.
Amgen (NASDAQ:AMGN) presented positive Phase 3 data for UPLIZNA® (inebilizumab-cdon) in treating generalized myasthenia gravis (gMG) at AANEM 2024. The MINT study met its primary endpoint, showing a statistically significant change in MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) at Week 26. The trial included both AChR+ and MuSK+ patients, with continued improvement through Week 26. Notably, corticosteroid use was tapered down during the study.
Key secondary endpoints also showed significant improvements, including changes in QMG scores and MG-ADL scores for specific patient populations. The safety profile was consistent with previous findings. MINT is the largest placebo-controlled gMG clinical trial for a biologic therapy, enrolling 238 adults. Amgen plans to file for approval in the U.S. and other key markets based on these results.
Amgen (NASDAQ: AMGN) has partnered with actress and entrepreneur La La Anthony to share her personal journey with plaque psoriasis and encourage open dialogue between patients and doctors about the disease's impact on daily life. La La, one of over 6 million Americans with plaque psoriasis, offers an intimate look at how the condition affects her personal and professional life in a new interactive video.
The campaign aims to raise awareness about the challenges of managing plaque psoriasis and the importance of finding suitable treatment options. La La emphasizes the need for patients to be vocal about how treatments impact their lifestyle. The initiative also highlights that plaque psoriasis is an autoimmune disease starting with internal inflammation, not just a skin condition.
Amgen's partnership with La La Anthony supports their commitment to helping plaque psoriasis patients access affordable treatment options, including Otezla® (apremilast), an oral medication that addresses underlying inflammation.
Amgen (NASDAQ:AMGN) announced that TEPEZZA® (teprotumumab) has been approved in Japan for the treatment of active Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare. TED is a serious, progressive autoimmune disease affecting approximately 25,000 - 35,000 people in Japan. TEPEZZA is the first and only medicine approved in Japan to treat active TED.
The approval was based on the positive results of the OPTIC-J Phase 3 study, where 89% of patients treated with TEPEZZA showed clinically meaningful improvement in proptosis compared to 11% with placebo. TEPEZZA received orphan drug designation in Japan, allowing for a faster regulatory review. A separate trial for chronic TED patients in Japan is ongoing.
This marks TEPEZZA's first approval in Asia, offering a nonsurgical and nonsteroidal option that treats a root cause of TED. TEPEZZA is also approved in the United States, Brazil, and Saudi Arabia, and is under review in Europe, Canada, and Australia.
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