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 (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.
Amgen (NASDAQ:AMGN) has announced a webcasted conference call for the investment community on Tuesday, September 24, 2024, at 1:30 p.m. PT. The call will focus on discussing new topline clinical data from the rocatinlimab (AMG 451/KHK4083) and UPLIZNA® (inebilizumab-cdon) Phase 3 programs.
Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen, along with other team members, will participate in the call. The webcast will be accessible to news media, investors, and the general public via Amgen's website at www.amgen.com under the Investors section.
The webcast will be archived and available for replay for at least 90 days after the event. Information about presentation times, webcast availability, and links can be found on Amgen's Investor Relations Events Calendar.
Amgen (NASDAQ: AMGN) announced new data presentations at the European Society for Medical Oncology (ESMO) Congress 2024, showcasing its oncology pipeline and portfolio. Key presentations include:
1. Phase 1b study results of LUMAKRAS® plus Vectibix® with FOLFIRI for first-line KRAS G12C-mutated metastatic colorectal cancer.
2. Phase 1 data on AMG 193, an MTA-cooperative PRMT5 inhibitor, selected for a presidential symposium.
3. First-in-human study of xaluritamig for metastatic castration-resistant prostate cancer.
The presentations cover various cancer types, including colorectal, lung, prostate, and gastric cancers, using molecularly targeted therapies. This diverse data set reflects Amgen's strategy to advance multiple modalities for difficult-to-treat cancers, showcasing their leadership in oncology research.
Amgen (NASDAQ:AMGN) presented new data for IMDELLTRA™ (tarlatamab-dlle), a first-in-class DLL3-targeting BiTE® molecule, at the 2024 World Conference on Lung Cancer. The DeLLphi-303 study showed promising results for IMDELLTRA in combination with PD-L1 inhibitors as first-line maintenance therapy in ES-SCLC. Key findings include:
- Disease control rate of 62.5% for both IMDELLTRA plus durvalumab and atezolizumab
- 9-month overall survival of 91.8% with durvalumab and 86.7% with atezolizumab
- Manageable safety profile with no new safety concerns
Extended follow-up data from the DeLLphi-301 Phase 2 study demonstrated sustained anticancer activity in previously treated ES-SCLC patients, with a 40% objective response rate and median overall survival of 15.2 months.
Amgen (NASDAQ:AMGN) has announced its participation in the 2024 Wells Fargo Healthcare Conference on Thursday, Sept. 5, 2024 at 9:30 a.m. ET. Peter Griffith, executive vice president and CFO, and Jay Bradner, executive vice president of Research and Development and CSO, will represent Amgen at the event.
The presentation will be webcast live and made available to the public, media, and investors. The webcast can be accessed on Amgen's website (www.amgen.com) under the Investors section. Amgen's Investor Relations Events Calendar provides details on presentation times and webcast links. The webcast will be archived for at least 90 days after the event for later viewing.
Amgen (NASDAQ:AMGN) is set to participate in the Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, Sept. 4, 2024, at 9:15 a.m. ET. Robert A. Bradway, Amgen's chairman and CEO, will be presenting at the event.
The presentation will be webcast live and made available to the public, media, and investors. Interested parties can access the webcast through Amgen's website (www.amgen.com) under the Investors section. The company's Investor Relations Events Calendar provides details on presentation times and webcast links.
This webcast, along with other selected presentations on Amgen's business developments, will be archived and available for replay for at least 90 days after the event.
Amgen (NASDAQ:AMGN) announced that Otezla® (apremilast) is now available in the U.S. for pediatric use, following FDA approval for treating moderate to severe plaque psoriasis in children and adolescents ages 6 and older weighing at least 20 kg. This marks the first and only FDA-approved oral medication for this condition in this patient population.
The approval was based on the SPROUT Phase 3 study, which demonstrated significant efficacy with a 33.1% sPGA response for Otezla versus 10.8% for placebo. The safety profile was consistent with that observed in adult patients. Dosage is weight-based, with 20 mg or 30 mg administered twice daily after initial titration.
This expansion of Otezla's use represents a new treatment option for younger patients with plaque psoriasis, potentially offering relief to many who previously had choices.
Amgen (NASDAQ: AMGN) reported its Q2 2024 financial results showing a 20% revenue increase to $8.4 billion compared to Q2 2023. Product sales grew by 20% with a 26% volume boost, albeit offset by a 3% decline in net selling price. Excluding Horizon Therapeutics' sales, product sales were up by 5%.
GAAP EPS fell 46% to $1.38, affected by higher operating costs, while non-GAAP EPS decreased 1% to $4.97. Free cash flow dropped to $2.2 billion from $3.8 billion due to timing of tax payments. The company remains on track to reduce its debt by more than $10 billion by the end of 2025.
Strong performers included Prolia® (13% sales increase), Repatha® (25%), and TEZSPIRE® (76%). However, some products like Enbrel® and Otezla® saw declines in sales. Amgen's guidance for 2024 predicts revenue between $32.8 billion and $33.8 billion, with GAAP EPS between $6.57 and $7.62, and non-GAAP EPS between $19.10 and $20.10.
Amgen (NASDAQ:AMGN) has announced its third quarter dividend for 2024. The company's Board of Directors has declared a dividend of $2.25 per share, which will be paid on September 6, 2024. This dividend is available to all stockholders of record as of the close of business on August 16, 2024. This announcement demonstrates Amgen's commitment to providing regular returns to its shareholders, which may be viewed positively by investors looking for stable income-generating stocks in the biotechnology sector.
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