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 ...

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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 ...

Eli Lilly's biggest growth drivers today are its weight loss drugs.Eli Lilly (LLY -0.14%) sells a broad portfolio of products, but two in particular have helped revenue growth explode in recent times. I'm talking about Lilly drugs that doctors prescribe for weight loss: Mounjaro and Zepbound. They're both based on the same molecule, but regulators approved the product for type 2 diabetes under the name Mounjaro and specifically for weight management under the name Zepbound.The company won approval for Mounj ...

Amgen (AMGN) announced that the FDA has granted accelerated approval to tarlatamab for pre-treated advanced small cell lung cancer (ES-SCLC).Tarlatamab is a delta-like ligand 3 targeting Bispecific T-cell Engager (BiTE) therapy, approved by the name of Imdelltra to treat ES-SCLC patients whose disease has progressed on or after treatment with platinum-based chemotherapy.The approval comes a month ahead of the PDUFA date on Jun 12. With the approval, Imdelltra becomes the first DLL3-targeting BiTE therapy th ...

Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult ...

flying white dove isolated on black backgroundgettyRemember when the Federal Reserve stopped printing money for a few months? It didn’t go well.Yes, I’m making fun. A bit. Chairman Jay Powell did abstain from his printing press for nine full months.The year, as you’ll recall, was 2022. Headline inflation topped 8%. Eight! Jay, who had been blaming every supply chain from here to Shanghai for the price pressures, ran out of excuses. He held down the power button on his money printer for a hard reset.Stocks s ...

THOUSAND OAKS, Calif., May 15, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcasted call for the investment community at 1:00 p.m. PT on Monday, May 20, 2024 following the presentation of new data from TEZSPIRE® in chronic obstructive pulmonary disease (COPD) at the American Thoracic Society (ATS) International Conference on May 19 and 20, 2024. The presentation will also include an overview of additional programs from Amgen's innovative inflammation portfolio. Jay Bradner, executive vice presiden ...