THOUSAND OAKS, Calif., April 28, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its first quarter 2025 financial results on Thursday, May 1, 2025, after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen's senior management team.Live audio of the conference cal ...

The first-quarter earnings season for the drug and biotech sector will be in full swing this week, with many large drugmakers like Pfizer (PFE) , Eli Lilly (LLY) , Amgen (AMGN) , Biogen (BIIB) , and Regeneron Pharmaceuticals (REGN) , among others, due to announce results. Johnson & Johnson and Merck have already reported results, with both beating first-quarter estimates for earnings and sales. French drugmaker Sanofi came out with mixed first-quarter results as it beat estimates for earnings but missed the ...

Core Points - Amgen announced a $900 million expansion of its manufacturing facility in Ohio, increasing total investment in Central Ohio to over $1.4 billion and creating 750 jobs [1][2] - The expansion is part of Amgen's commitment to U.S. manufacturing and aims to enhance its global biomanufacturing network [2][4] - Since the Tax Cuts and Jobs Act of 2017, Amgen has invested nearly $5 billion in the U.S., generating an estimated $12 billion in additional economic output [3] Company Overview - Amgen has been a leader in biologic medicine manufacturing since 1988 and emphasizes innovation and access to medicines for patients worldwide [2][5] - The company has a strong pipeline targeting various diseases, including cancer and heart disease, and has received multiple accolades for its innovation and workplace environment [6] Economic Impact - Ohio's supportive business climate and skilled workforce have made it an attractive location for Amgen's investments, contributing to the state's economic development [3] - The expansion in Ohio follows a recent announcement of a $1 billion investment for a second manufacturing plant in Holly Springs, NC, indicating a broader strategy to enhance U.S. manufacturing capabilities [4]

Amgen (AMGN) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 1. On the oth ...

Today, Amgen (NASDAQ: AMGN ) is a global biopharmaceutical company with a presence in almost a hundred countries and one of the most extensive product portfolios in the industry. Over the past couple of years, the company has competentlyMy professional background spans multiple continents and includes experience in private banking, corporate finance, and strategic advisory. For several years, I developed and led a private banking department in Dubai, where I crafted tailored investment solutions to meet the ...

Core Insights - Amgen's IMDELLTRA® (tarlatamab-dlle) has shown a substantial survival advantage over standard chemotherapy in patients with small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy, as demonstrated in the Phase 3 DeLLphi-304 clinical trial [1][2][3] Group 1: Clinical Trial Results - The DeLLphi-304 trial met its primary endpoint, showing statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care chemotherapy [1][3] - IMDELLTRA is indicated for adult patients with extensive-stage SCLC who have disease progression on or after platinum-based chemotherapy, with approval based on overall response rate and duration of response [5][6] Group 2: Drug Mechanism and Target Population - IMDELLTRA is a first-in-class immunotherapy that targets DLL3 on tumor cells and CD3 on T cells, leading to the destruction of DLL3-expressing SCLC cells [4][6] - DLL3 is expressed on approximately 85-96% of SCLC patients, making it a promising target for therapy [4][6] Group 3: Safety and Efficacy - The safety profile of IMDELLTRA was consistent with its known profile, and detailed data from the trial will be presented at an upcoming medical congress [2][3] - Serious adverse reactions occurred in 58% of patients, with cytokine release syndrome (CRS) being the most common [26][27] Group 4: Future Developments - Amgen is advancing a robust development program for tarlatamab, including multiple ongoing clinical trials evaluating its efficacy in various treatment settings for SCLC [8][9]

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for a new indication to treat immunoglobulin G4-related disease (IgG4-RD), marking it as the first and only FDA-approved treatment for this condition [1][2]. Group 1: Drug Approval and Market Impact - Uplizna is now approved for treating adults with IgG4-RD, a chronic disease with significant unmet medical needs [2]. - The approval is based on the phase III MITIGATE study, which demonstrated an 87% reduction in the risk of flares compared to placebo [3][4]. - Year to date, Amgen's shares have increased by 18.9%, outperforming the industry average rise of 1.2% [2]. Group 2: Clinical Study Insights - The MITIGATE study's primary endpoint was to assess the time to first flare in patients with IgG4-RD [3]. - In the study, 58.8% of Uplizna-treated participants achieved flare-free, corticosteroid-free, and complete remission at week 52, compared to 22.4% in the placebo group [4]. Group 3: Future Developments - Amgen is also exploring Uplizna for generalized myasthenia gravis (gMG) and plans to submit a regulatory filing for this indication by the first half of 2025 [5][6]. - Uplizna generated sales of $379 million in 2024, and further label expansions are expected to drive sales growth in future quarters [6].

Core Viewpoint - The Trump administration's recent tariffs have significantly impacted the stock market, with pharmaceuticals and biotech being relatively less affected compared to other sectors [1][2]. Industry Impact - The stock market experienced one of its worst trading days, with the S&P 500 dropping by 4.8%, while Catalyst Pharmaceuticals and Veeva Systems saw smaller declines of 1.5% and 2%, respectively. Notably, Amgen and AstraZeneca reported gains of 1.5% and 2.4% [2]. - The pharmaceutical sector was notably absent from the list of tariffs, which had initially included a proposed 25% duty on foreign pharmaceutical manufacturers [3][4]. Future Considerations - The exemption from tariffs is temporary, and there are indications that the administration may soon impose tariffs specifically targeting pharmaceutical exports [4][5]. - The pharmaceutical industry has powerful lobbyists advocating for reduced tariffs, which may have influenced the temporary exemption [5][6]. Regulatory Developments - Despite the looming threat of tariffs, the pharmaceutical industry continues to announce positive developments, such as Amgen's FDA approval for its Uplizna drug to treat IgG4-related disease, marking a significant advancement for patients [9][10]. - The approval of Uplizna is expected to reduce reliance on long-term steroid use for patients, highlighting the industry's ongoing commitment to regulatory approvals and medication development [10].

Core Insights - Amgen's UPLIZNA has received FDA approval as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet medical need in this chronic and debilitating condition [1][2][8] Company Developments - The approval of UPLIZNA is a pivotal moment for patients and healthcare providers, offering a proven treatment that targets a key driver of IgG4-RD, thereby reducing the risk of flares and reliance on long-term steroid use [2][3] - UPLIZNA's efficacy is supported by data from the MITIGATE trial, which demonstrated an 87% reduction in the risk of IgG4-RD flares compared to placebo [9] - UPLIZNA is also indicated for the treatment of AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) and has received Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory filings for gMG expected to be completed in H1 2025 [1][8] Clinical Trial Insights - The MITIGATE trial was the first randomized, double-blind, placebo-controlled trial for IgG4-RD, showing significant reductions in disease activity and flares among patients treated with UPLIZNA [4][5] - Key findings from the trial include that 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, and complete remission at Week 52, compared to 22.4% in the placebo group [9] - UPLIZNA-treated patients experienced a ten-fold reduction in mean total glucocorticoid use for disease control compared to those on placebo [9] Disease Background - IgG4-RD is a chronic, systemic, immune-mediated disease that can affect multiple organs and lead to fibrosis and permanent organ damage [6] - The disease is characterized by unpredictable inflammatory flares and can mimic other conditions, complicating timely diagnosis [6][7] - The prevalence of IgG4-RD is estimated at 20,000 people in the U.S., with a higher incidence in men and typical onset between ages 50 and 70 [6]

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