Data Show a Statistically Significant 87% Reduction in IgG4-RD Flares, With Primary and All Key Secondary Endpoints MetFirst Randomized, Placebo-Controlled Trial to Demonstrate Benefit in IgG4-RDTHOUSAND OAKS, Calif., June 5, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) for the treatment of Immunoglobul ...

AltaybIntroduction I imagine the dream of every Formula 1 driver is to win a Championship, the dream of every football player is to win the Super Bowl, and the dream of every politician to eventually call the Oval Office their workplace. Healthcare/biotech investors probably dream of their companies launching a product that is as successful as the latest weight loss drugs from Eli Lilly (LLY) and Novo Nordisk (NVO), whose shares have gained 611% and 471% over the past five years alone, respectively. Dat ...

There's probably a big enough pie here for everyone to get a slice.Eli Lilly and Novo Nordisk are, so far, the kings of the weight-loss gold rush. Thanks to their medicines, Zepbound and Wegovy, billions in new revenue inflows are assured in the near term.But those two juggernauts aren't the only competitors looking to get a slice of the action -- they're just the first. Three aspiring contenders are raring to go, and they might even be able to claim the crown one day. Let's take a look at each to see if an ...

The Amgen of 2027 could be much be larger than some investors expect.If you're looking for an investment in the pharmaceutical sector and you don't already own shares of Amgen (AMGN -1.85%), it might be worth considering a purchase. The company's development of highly technological cancer therapies is almost certain to expand over time, and its pipeline is packed with candidates for next-generation medicines. Many of those candidates will likely get their shot at approval by regulators.So let's see where Am ...

Data From Newly FDA-Approved IMDELLTRA™ (tarlatamab-dlle) Further Reinforce Leadership in Bispecific T-Cell EngagersOverall Survival Data from Phase 3 LUMAKRAS® (sotorasib) Plus Vectibix® (panitumumab) in Metastatic Colorectal Cancer Accepted as Late-Breaking Oral PresentationTHOUSAND OAKS, Calif., May 28, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its broad oncology portfolio at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking plac ...

The gold rush for obesity medications just got a bit more intense.With some promising clinical trial results in hand and more that could be on the way relatively soon, Amgen's (AMGN -0.21%) latest attempt to develop a therapy for obesity is looking like it could be a contender for the crown that's currently jointly held by the likes of Eli Lilly (LLY -0.13%) and Novo Nordisk (NVO 0.35%). Though it won't be competing with those two heavyweights directly until it finishes the clinical trials process, which co ...

If you’re on the hunt for reliable blue-chip stocks to buy this month, look no further. Reliability is one of the most important factors when creating a winning investment strategy. One of the easiest ways to ensure reliability is by investing in blue-chip stocks. Blue-chip stocks represent well established companies with long track records of success. They often have a long history of reliable earnings and many times pay dividends. In short, they are among the most reliable investments available.In general ...

Summary of Amgen, Inc. Conference Call on IMDELLTRA Approval Company Overview - **Company**: Amgen, Inc. (NASDAQ: AMGN) - **Event**: Conference Call regarding the approval of IMDELLTRA and updates on various therapeutic areas - **Date**: May 20, 2024 Key Points Industry and Product Focus - **Therapeutic Areas**: Amgen operates across four pillars: general medicine, oncology, inflammation, and rare diseases [6][7] - **IMDELLTRA**: A bispecific T-Cell engager therapy approved for extensive-stage small-cell lung cancer, marking a significant advancement in cancer treatment [10][11] IMDELLTRA Highlights - **Approval Significance**: IMDELLTRA is the first chemotherapy-free targeted immunotherapy for extensive-stage small-cell lung cancer, demonstrating a 40% overall response rate and a median overall survival of 14.3 months [10][11][17] - **Clinical Data**: - 9.7 months median duration of response - 70% disease control rate among treated patients [16][17] - **Market Potential**: Approximately 8,000 to 10,000 patients in the U.S. are eligible for IMDELLTRA treatment [20] Launch Strategy - **Rollout Plan**: Focus on healthcare facilities experienced with advanced therapies, aiming for accessibility in community settings where 70% of small-cell lung cancer patients are treated [22][23] - **Education and Support**: Amgen is committed to educating healthcare providers about BiTE therapies and providing patient support services [24] Inflammation and Other Therapeutics - **TEZSPIRE**: - Approved for severe asthma, with plans to expand into chronic obstructive pulmonary disease (COPD) [29] - First-quarter sales for severe asthma increased by 80% year-over-year [9] - **AMG 104**: An inhaled TSLP inhibitor for uncontrolled asthma, with Phase 1 data showing promise [36] - **Rocatinlimab**: Aiming to address atopic dermatitis, with a comprehensive Phase 3 program underway [41] Market Context and Competitive Landscape - **COPD Market**: High unmet medical need with an estimated 14 million diagnosed patients in the U.S. [29] - **Eosinophil Count**: TEZSPIRE shows efficacy in patients with blood eosinophil counts as low as 150 cells per microliter, expanding potential patient population [35] Safety and Efficacy - **IMDELLTRA Safety Profile**: Manageable side effects with low rates of permanent discontinuation due to adverse reactions [18] - **TEZSPIRE Efficacy**: Demonstrated significant reductions in COPD exacerbations, particularly in patients with higher eosinophil counts [35] Future Outlook - **Long-term Growth**: Amgen is optimistic about delivering sustained growth through innovative therapies across its portfolio [44] Additional Insights - **Real-World Data**: Emphasized the poor prognosis of small-cell lung cancer, with median overall survival in untreated patients being only 5-7 months [14] - **Commitment to Innovation**: Amgen's focus on addressing critical unmet needs in various diseases highlights its dedication to improving patient outcomes [43] This summary encapsulates the key points discussed during the conference call, focusing on Amgen's strategic initiatives, product developments, and market positioning.

Amgen, Inc. (NASDAQ:AMGN) ATS and the Approval of IMDELLTRA Conference Call May 20, 2024 4:00 PM ET Company Participants Justin Claeys - Vice President of Investor Relations Murdo Gordon - Executive Vice President, Global Commercial Operations James Bradner - Executive Vice President, Research and Development Jean-Charles Soria - Senior Vice President, Global Development Oncology Susan Sweeney - Senior Vice President, Global Marketing, Access Capabilities Primal Kaur - Vice President, Global Development, In ...

Fundamentally, one of the biggest advantages of biotech stocks to buy centers on the underlying prioritization. While the media focuses on attaining wealth, that doesn’t mean much if you don’t have health. Therefore, this compelling subcategory of the broader healthcare market deserves attention.In addition, while the market has been robust – with the Dow Jones Industrial Average breaching the 40,000-point level – many concerns exist. Inflation remains elevated as are borrowing costs. Delinquency rates are ...