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) 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.
Amgen (NASDAQ:AMGN) has announced that it will report its second quarter 2024 financial results on Tuesday, August 6, 2024, after the close of U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET. Robert A. Bradway, chairman and CEO, along with other senior management team members, will participate in the call.
The conference call will be broadcast live over the internet and will be accessible to news media, investors, and the general public. The webcast can be found on Amgen's website under the Investors section. The webcast will be archived and available for replay for at least 90 days after the event.
Amgen (NASDAQ: AMGN) announced FDA approval for BLINCYTO® (blinatumomab) for treating CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. This marks BLINCYTO's third indication.
Data from the Phase 3 E1910 trial showed BLINCYTO, added to chemotherapy, reduces the risk of death by 58% and improves overall survival (OS). The 3-year OS was 84.8% with BLINCYTO plus chemotherapy compared to 69% with chemotherapy alone. The study had a median follow-up of 4.5 years.
This approval provides a new standard of care for B-ALL patients, offering a more effective treatment option than chemotherapy alone.
Amgen (NASDAQ:AMGN) presented several significant findings at the European Alliance of Associations for Rheumatology's (EULAR) 2024 Congress. The event, held from June 12-15 in Vienna, showcased 27 abstracts from Amgen-sponsored and partner-led studies. Key highlights include improvements in biomarkers for Sjögren's disease with dazodalibep, positive outcomes for uncontrolled gout with KRYSTEXXA® (pegloticase) combined with methotrexate, and long-term data from the FOREMOST study of Otezla® (apremilast) in early oligoarticular psoriatic arthritis. Additional studies covered topics like psoriatic arthritis, osteoporosis, and ANCA-associated vasculitis. This data underscores Amgen's commitment to advancing treatment options for inflammatory and rheumatic diseases.
Amgen (NASDAQ: AMGN) will be presenting at the Goldman Sachs 45th Annual Global Healthcare Conference. The presentation is scheduled for June 10, 2024, at 9:20 a.m. ET. Key speakers include Peter Griffith, executive vice president and CFO, and Jay Bradner, executive vice president of R&D and chief scientific officer. The presentation will be webcast live and archived for replay on Amgen's website for at least 90 days. This offers insights into Amgen's ongoing business developments and is accessible to media, investors, and the general public.
Amgen announced positive results from a Phase 3 registrational trial evaluating UPLIZNA® (inebilizumab-cdon) for treating Immunoglobulin G4-related disease (IgG4-RD). The trial, conducted at 80 sites across 22 countries, showed a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo, meeting all primary and key secondary endpoints. No new safety signals were identified, and the overall safety profile was consistent with known data. The results mark a significant milestone in treating IgG4-RD, which currently has no approved therapy. Amgen plans to file for approval in the U.S. and other key markets.
Amgen (NASDAQ: AMGN) will present at the Jefferies Global Healthcare Conference on June 6, 2024, at 9:00 a.m. ET. Key speakers include Peter Griffith, Executive Vice President and CFO, and Ian Thompson, Senior Vice President of U.S. Business Operations. The presentation will be webcast live and accessible to the public, including investors and media, on Amgen's website. The webcast will also be archived for 90 days for replay.
Amgen will present significant research findings from its oncology portfolio at the ASCO 2024 Annual Meeting. Highlights include data from the newly FDA-approved IMDELLTRA™ (tarlatamab-dlle) and overall survival results from the Phase 3 LUMAKRAS® (sotorasib) plus Vectibix® (panitumumab) study in metastatic colorectal cancer. The company showcases 17 abstracts, emphasizing cutting-edge advancements in treating difficult cancers. Key presentations include Phase 2 DeLLphi-301 study results in small cell lung cancer, Phase 1b DeLLpro-300 study in neuroendocrine prostate cancer, and updated Phase 1b CodeBreaK 101 trial data in advanced non-small cell lung cancer.