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Eli Lilly cautious on using FDA fast-track voucher for weight loss pill
Reuters· 2025-09-17 07:43
Core Insights - Eli Lilly's international president Patrik Jonsson expressed uncertainty regarding the U.S. Food and Drug Administration's new fast-track review process, indicating that it is too early to assess its implications for the company [1] Group 1 - The company is currently lacking clarity on the new fast-track review process implemented by the FDA [1] - Jonsson's comments suggest that the company is cautious about the potential impacts of this new regulatory approach [1]
Global Markets Cautious Ahead of FOMC, Drugmakers Pledge Billions in US Investment
Stock Market News· 2025-09-17 00:39
Group 1: Pharmaceutical Industry Investments - Major pharmaceutical companies are committing over $350 billion in U.S. investments by the end of the decade, driven by potential tariff threats from the Trump administration on imported medicines [2][8] - Eli Lilly and Company announced a $5 billion investment for a new manufacturing facility in Virginia, focusing on active pharmaceutical ingredients for advanced therapies, expected to create 2,450 high-wage jobs [3][8] - Other drugmakers like GSK, AstraZeneca, and Johnson & Johnson are also making multi-billion dollar investments in their U.S. operations [3] Group 2: Mining and Copper Production - Mitsubishi Corporation, through its stake in Anglo American Sur S.A., finalized a joint mine plan with Codelco for the Los Bronces and Andina copper mines, projected to unlock at least $5 billion in additional pre-tax value [4][5][8] - The joint venture is expected to yield an additional 120,000 tonnes of copper production annually over a 21-year period, starting in 2030, with shared economic benefits [5] Group 3: Data Center and AI Development - Keppel Corporation has partnered with Dell Technologies to collaborate on data centers and develop AI platforms across Asia, aiming to nearly double its data center capacity to 1.2 gigawatts within three to five years [9][8] Group 4: Market Trends and Economic Indicators - Asia-Pacific stock markets opened lower as investors adopted a cautious stance ahead of the U.S. FOMC policy decision, with declines in Australia's S&P/ASX 200, Japan's Nikkei 225, and South Korea's KOSPI [6][8] - Japan's August trade deficit narrowed to -¥242.5 billion, outperforming estimates, with exports declining by only -0.1% year-on-year, while imports decreased by -5.2% [7][8]
礼来(LLY.US)口服减肥药试验减重11.2% 医生:或重塑肥胖治疗格局
Zhi Tong Cai Jing· 2025-09-17 00:15
Core Insights - Eli Lilly's oral weight loss drug Orforglipron has shown a significant weight reduction effect of 11.2% in obese adult patients during a large clinical trial, with side effects comparable to current injectable products [1] - The oral formulation of Orforglipron is expected to greatly enhance treatment accessibility, as it is easier to produce and use compared to injectable options, potentially leading to better pricing advantages [1] - The obesity treatment market is projected to reach $100 billion in annual sales by 2030, with Eli Lilly and Novo Nordisk competing for market leadership [1] Company-Specific Insights - Eli Lilly's Orforglipron is classified as a "small molecule drug," which allows for more efficient production and fewer usage restrictions compared to Novo Nordisk's injectable product that contains semaglutide [2] - Despite initial challenges in meeting market expectations, recent data on Orforglipron's efficacy in treating obese patients with diabetes has renewed confidence in its sales potential [2] - Eli Lilly plans to submit a regulatory approval application by the end of the year and has requested expedited review from the FDA, aiming for a market launch in 2024 [2] Industry Insights - The shift towards oral formulations in the obesity treatment market is a key competitive direction, with significant implications for patient access and treatment outcomes [1][2] - The clinical trial data indicates that over 10% weight loss is sufficient to produce significant clinical effects, emphasizing the importance of ease of access to oral medications [2] - Novo Nordisk may release an oral version of Wegovy sooner, but has faced production capacity issues that have slowed its development [2]
美股三大指数小幅收跌,市场静待美联储利率决议,中概股多数上涨
Feng Huang Wang· 2025-09-16 22:27
Market Overview - The three major U.S. stock indices closed lower amid cautious trading ahead of the Federal Reserve's interest rate decision, with expectations of a 25 basis point rate cut to counteract the deteriorating labor market [1] - The Dow Jones fell by 125.18 points (0.27%) to 45758.27, the Nasdaq decreased by 14.79 points (0.07%) to 22333.96, and the S&P 500 dropped by 8.49 points (0.13%) to 6606.79 [3] Economic Indicators - U.S. retail sales data for August showed a higher-than-expected increase, indicating strong consumer spending, yet this did not alter market expectations for a rate cut [1] - Principal Asset Management's global chief strategist noted that while labor demand is slowing, the risk of recession remains limited, suggesting a moderate 25 basis point cut is more appropriate than a larger reduction [2] Company News - Eli Lilly announced a $5 billion investment to build a manufacturing facility in Virginia, aimed at enhancing the production of targeted cancer therapies and other advanced treatments, resulting in a stock price increase of over 2.2% [7] - Google, in collaboration with over 60 organizations, launched the Agent Payments Protocol (AP2) to facilitate secure AI-driven payment processing across platforms, indicating a shift towards AI-driven business models [8] - Novo Nordisk reported positive results from a Phase 3 trial of its new weight loss drug Cagrilintide, showing an average weight loss of 11.8% over 68 weeks compared to 2.3% in the placebo group [9] - Microsoft plans to invest over $30 billion in the UK over the next four years, including $15.5 billion for capital expansion and $15.1 billion for various business initiatives [10] Stock Performance - Major tech stocks showed mixed results, with Tesla up 2.82%, Meta up 1.87%, and Amazon up 1.13%, while Microsoft and Nvidia saw declines of 1.23% and 1.61%, respectively [4] - Webtoon Entertainment's stock surged by 39% following a partnership with Disney to launch a new digital comic platform [4] - New Fortress Energy's stock rose by 45% after securing a $4 billion, seven-year agreement to supply liquefied natural gas to Puerto Rico [4] - Occidental Petroleum's shares increased by 5% due to concerns over supply tightness following an attack on a Russian refinery [5]
X @Bloomberg
Bloomberg· 2025-09-16 22:16
Clinical Trial Results - Lilly's obesity pill demonstrated significant weight loss in a large clinical trial, suggesting meaningful benefits for patients [1] Industry Implications - The weight loss results from Lilly's obesity pill trial could have far-reaching implications for the obesity treatment field [1]
Why Eli Lilly Stock Was a Winner Today
Yahoo Finance· 2025-09-16 22:15
Core Insights - Eli Lilly's stock experienced a rise of over 2% following positive news regarding a potential blockbuster drug and an expansion of manufacturing capabilities [1] Drug Development - Eli Lilly's next-generation obesity drug, orforglipron, may receive FDA approval by the end of this year due to a fast-tracked review process [2][3] - The FDA's new program allows investigational drugs to be reviewed in 1-2 months, significantly shorter than the standard 10-month review period [3] - Analysts believe orforglipron is a strong candidate for this expedited process as it addresses a high-burden chronic condition and can be competitively priced [4] Manufacturing Expansion - Eli Lilly plans to build a new manufacturing facility in Virginia, with an estimated cost of $5 billion, focusing on antibody-drug conjugates [4] - This Virginia plant is part of a broader capital expansion initiative, with Eli Lilly committing $50 billion to various projects, including factory construction, since 2020 [5]
Lilly trial shows weight loss with experimental pill flattens over time
Reuters· 2025-09-16 22:04
Core Insights - Eli Lilly's experimental GLP-1 pill demonstrated an approximate 12% reduction in body weight among participants in a 72-week trial, with weight loss stabilizing for most patients [1] Group 1 - The study results were presented at a recent conference, highlighting the effectiveness of the GLP-1 pill in weight management [1] - The trial duration of 72 weeks indicates a long-term assessment of the drug's impact on weight loss [1] - The plateauing of weight loss suggests that while initial results are promising, further investigation may be needed to understand long-term efficacy [1]
Lilly CEO: U.K. has gone from biopharma leader to laggard
CNBC Television· 2025-09-16 22:02
we're seeing you and other companies pulling back from the UK. You know, just last week saw that you were pausing um one of your investments there. So, what's happening in the UK and you know, should that send a message to policy makers here in the US.>> Probably it should. I mean, I think uh the UK has been on a a long slow glide path from a leader in biofarmaceuticals to really a lagard and that's happened over the last 20 years through a number of policy mistakes. Um the most important one is that their ...
Lilly CEO: U.K. has gone from biopharma leader to laggard
Youtube· 2025-09-16 22:02
Core Viewpoint - The UK has been declining as a leader in biopharmaceuticals due to policy mistakes, making it unattractive for investment, which should serve as a warning to US policymakers [2][5]. Investment Environment - The UK market has become increasingly unattractive for investment over the years, despite having a strong academic and scientific base [3][5]. - The company has paused investments in the UK, awaiting policy changes from the new administration [4][5]. Policy Issues - The UK pricing system for new medicines is outdated, pegged to a value from 1997, which has not adjusted for healthcare inflation of 4-5% per year, effectively debasing the value of new medicines [6][7][8]. - The UK spends half per capita on medicine compared to the US on a GDP-adjusted basis, indicating a need for policy reform to improve investment attractiveness [8]. - A tax imposed on the pharmaceutical industry for budget overruns in healthcare, which was 23% of sales last year, is seen as detrimental to attracting investment [9][10]. Global Competition - The US is a leader in the invention of new medicines, with 70% of global new medicines developed there, highlighting the importance of maintaining overseas markets for these products [14][15]. - The current pricing policies in Europe, including the UK, hinder the ability to raise prices and attract investment, which is essential for the sustainability of the industry [11][15]. Market Dynamics - The reimbursement process for new medicines in the UK is slow, often taking years, which contrasts with the immediate availability of new products in the US [18][19]. - The company believes that if the UK were to reimburse certain medicines, such as Mjaro for obesity, it could significantly impact health costs in the country [17].
Lilly's oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine
Prnewswire· 2025-09-16 22:01
Core Insights - Eli Lilly's investigational drug orforglipron shows significant weight loss and cardiometabolic improvements in adults with obesity or overweight, as demonstrated in the Phase 3 ATTAIN-1 trial [1][5][8] Group 1: Study Results - Orforglipron led to an average weight loss of 27.3 lbs (12.4%) at the highest dose after 72 weeks, with all doses meeting the primary endpoint of superior body weight reduction compared to placebo [1][2] - Key secondary endpoints showed that 59.6% of participants on the highest dose lost at least 10% of their body weight, and 39.6% lost at least 15% [1][3] - Among participants with prediabetes, 91% taking orforglipron achieved near-normal blood sugar levels compared to 42% in the placebo group [1][4] Group 2: Cardiovascular Risk Factors - Orforglipron demonstrated clinically meaningful improvements in non-HDL cholesterol, systolic blood pressure, and triglycerides, indicating its potential to reduce cardiovascular risk associated with obesity [1][4] - The highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels by 47.7%, a marker of inflammation [1] Group 3: Safety Profile - The safety profile of orforglipron was consistent with the GLP-1 receptor agonist class, with common adverse events being gastrointestinal-related and generally mild to moderate [4] - The most frequently reported adverse events included nausea (28.9% to 35.9%), constipation (21.7% to 29.8%), diarrhea (21.0% to 23.1%), and vomiting (13.0% to 24.0%) across different doses compared to placebo [4] Group 4: Regulatory and Market Potential - Eli Lilly is advancing orforglipron toward global regulatory submissions for obesity treatment, with action expected as early as next year, and for type 2 diabetes anticipated in 2026 [5][8] - Orforglipron is positioned as a convenient, once-daily oral medication that could be integrated into primary care settings, addressing various health markers for patients with obesity [4][8]