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The Justice Department indicted Adderall startup Done Global a month after its founder and top doctor were both convicted for a conspiracy to distribute controlled substances https://t.co/5PHM5UaKqc ...
Tenax Therapeutics Announces Result of Prespecifed Blinded Sample Size Assessment
Globenewswire· 2025-12-17 14:16
Core Insights - Tenax Therapeutics announced that the Blinded Sample Size Re-estimation (BSSR) of the LEVEL trial shows it is adequately powered to detect a 25-meter change in the 6-minute walk distance (6MWD), confirming that the target enrollment remains unchanged and is expected to complete in the first half of 2026 [1][2][3] Group 1: LEVEL Study Details - LEVEL is a Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) for patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the U.S. and Canada [2] - The BSSR results indicated that the observed change in 6MWD from the first 150 randomized patients was less than the assumed 55 meters [2] - The company expects to share topline data in the second half of 2026 and remains confident in executing its Phase 3 development plan for TNX-103 [3] Group 2: LEVEL-2 Study Initiation - Tenax has initiated LEVEL-2, a global Phase 3 study of TNX-103, aiming to enroll approximately 540 PH-HFpEF patients with a 2:1 randomization to receive TNX-103 or placebo [3][4] - The primary endpoint for LEVEL-2 is the change in 6MWD at Week 26, with secondary endpoints including changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class [3] Group 3: Global Study Sites and Safety Observations - Over 100 sites across 15 countries have been selected for participation in LEVEL-2, with a rigorous process implemented to ensure consistency in patient hemodynamic assessments [4] - The LEVEL-2 study includes a 6-month blinded safety observation following the 26-week efficacy assessment to provide a robust safety database for regulatory review [4] Group 4: Levosimendan Overview - Levosimendan is a first-in-class K-ATP channel activator/calcium sensitizer being evaluated for treating PH-HFpEF, with market authorization in 60 countries for intravenous use in acutely decompensated heart failure [5] - The Phase 2 HELP study demonstrated the potential of both intravenous (TNX-101) and oral (TNX-103) formulations to improve exercise capacity and quality of life in patients with PH-HFpEF [5] Group 5: Company Background - Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies, holding global rights to develop and commercialize levosimendan for PH-HFpEF, which currently lacks approved treatments [7]
LENZ Therapeutics: Was That A Market Overreaction?
Seeking Alpha· 2025-12-17 14:02
Company Overview - LENZ Therapeutics, Inc. experienced a significant decline in share price, falling approximately 25% following reports of an "adverse event" related to its leading drug, VIZZ [1] - The decline in shares has continued, with the stock now down around 30% from its previous levels [1] Market Reaction - The market's reaction to the adverse event indicates heightened investor concern regarding the safety and efficacy of VIZZ, which could impact future sales and the company's overall valuation [1]
Novo Nordisk (NVO) Hit By Lowered Guidance
Yahoo Finance· 2025-12-17 13:57
GreensKeeper Asset Management, an investment management company, released its third-quarter 2025 investor letter. A copy of the letter can be downloaded here. The Value Fund has ended the quarter with a +4.0% gain, taking the YTD return to +0.2% net of fees and expenses. The US dollar continued to pose a challenge, negatively impacting performance by -3.7% so far this year. The year’s market rally was primarily led by AI, crypto, and speculation. In addition, you can check the fund’s top 5 holdings to dete ...
Someone Told Mark Cuban He Could 'Literally End World Hunger' Without Affecting His Net Worth. Here's What He Answered
Yahoo Finance· 2025-12-17 13:54
Billionaire Mark Cuban isn't pretending to have all the answers. When someone on Bluesky said he could “literally end world hunger” without making a dent in his net worth, Cuban didn't brush it off. Instead, he answered, “I’m in! Tell me how.” Focused On What He Can Fix When a second user doubled down, saying Cuban must not be that smart if he didn't know how his wealth could help end hunger, Cuban fired back sarcastically: “I’m dumb. I can’t figure out how to end world hunger.” But he quickly pivoted to ...
速递|减重13.3%!华东医药GLP-1/GIP双靶点新药HDM1005 II期减重研究获积极结果
GLP1减重宝典· 2025-12-17 13:43
Core Viewpoint - The article highlights the positive results of the Phase II clinical trial for HDM1005, a GLP-1R/GIPR dual agonist developed by Huadong Medicine, demonstrating significant weight loss efficacy and good safety profile [4][9]. Mechanism of Action - HDM1005 activates both GLP-1R and GIPR, promoting cAMP production, which enhances insulin secretion, suppresses appetite, delays gastric emptying, and improves overall metabolic function [5]. - The drug also shows potential benefits in reducing plasma volume, lowering oxidative stress and systemic inflammation, and improving cardiovascular adaptability, indicating multiple therapeutic values including weight loss and glycemic control [5]. Phase II Study Design - The Phase II clinical trial included 243 participants over a 22-week treatment period, with a balanced comparison of baseline metrics such as weight, waist circumference, and BMI across dosage groups [6]. - The study employed a dose-escalation strategy with four dosage groups (0.5 mg, 1.0 mg, 2.0 mg, and 4.0 mg) compared to a placebo group [6]. Significant Weight Loss Results - The results indicated that participants in the highest dosage group (4.0 mg) experienced a weight reduction of 13.28% from baseline, while the placebo group saw a decrease of only 2.46% [7]. - The proportion of participants achieving a weight loss of ≥10% was notable: 75.0% in the 2.0 mg group and 70.8% in the 4.0 mg group, compared to 6.1% in the placebo group [7]. - Improvements in waist circumference (6.3–10.3 cm reduction) and BMI (2.4–4.2 kg/m² reduction) were also observed, alongside significant enhancements in various metabolic indicators [7]. Safety Profile - HDM1005 demonstrated a good safety and tolerability profile, with adverse events primarily being mild to moderate, and no serious treatment-related adverse events reported [8]. - Common side effects included decreased appetite and gastrointestinal reactions, with nausea and vomiting rates varying across dosage groups [8]. Overall Summary - HDM1005 shows strong weight loss effects, a clear dose-response relationship, and a favorable safety profile, positioning it for differentiated development within the competitive landscape of GLP-1 drugs [9].
Protalix BioTherapeutics partners with Secarna Pharmaceuticals on rare kidney disease drug development
Proactiveinvestors NA· 2025-12-17 13:41
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
The Ultimate High-Yield Drug Stock to Buy With $1,000 Right Now
Yahoo Finance· 2025-12-17 13:35
分组1 - Dividend investors should be cautious about seeking high yields, as it may expose them to additional risks while ensuring an attractive income stream is essential [1] - Eli Lilly's GLP-1 weight-loss drugs have seen significant sales growth, with Mounjaro sales up 109% year over year and Zepbound sales up 185% [2] - Eli Lilly has a reasonable dividend payout ratio of approximately 30%, but its yield is low at 0.6%, making it less appealing for income seekers [3][6] 分组2 - Pfizer offers a high dividend yield of 6.6%, but its payout ratio exceeds 100%, raising concerns about sustainability [3][6] - Pfizer faces challenges with upcoming patent expirations for key drugs between 2027 and 2028, and its GLP-1 drug candidate has not succeeded [3][4] - Merck presents a more balanced risk-reward option for dividend investors, with a yield of approximately 3.4% and a payout ratio of around 45%, making it a safer choice compared to Pfizer and Eli Lilly [5][7]
Moleculin Announces Positive Results from Phase 1 Clinical Trial Evaluating WP1066 for the Treatment of Pediatric Recurrent Malignant Brain Tumors
Globenewswire· 2025-12-17 13:31
Emory University physician-sponsored clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of AtlantaResults demonstrated WP1066 induces anti-tumor immune responses and were recently published in the Journal of Clinical Investigation Insight WP1066 found to be safe and effective, warranting a Phase 2 trial HOUSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced positive results from the Emor ...
海南探封关|记者实地探访,海南封关会带来哪些山东机遇
Sou Hu Cai Jing· 2025-12-17 13:14
齐鲁晚报·齐鲁壹点记者尹睿 魏银科 74%商品实现零关税、47大类免税商品扩容、双15%税收优惠、30%本地增值免关税......2025年12月18日,海南全岛封关运作将正式启动。作为我国自贸港 建设的里程碑事件,封关不仅将重塑海南的政策格局,更将释放涵盖消费、产业、贸易的多重红利。16日晚,记者抵达海口,实地探访封关前夕的热潮与 变革。 海口氛围拉满,免税店掀起"封关前消费热" 12月17日,海口沉浸在全岛封关运作前最后的倒计时氛围中,从空中门户到城市街巷,历史性时刻的期待感扑面而来。 在海口美兰国际机场,出港通道两侧、核心区域的电子大屏乃至悬挂的条幅,无不醒目地标注着"2025年12月18日 海南自贸港 全岛封关 正式启动"的标 语,让每一位抵达的旅客都直观感受到历史性时刻的临近。 市区里的氛围同样浓厚。在海口市骑楼老街北门广场,一块显示"距离海南自由贸易港封关运作还有01天"的巨型倒计时牌,成为市民游客争相打卡的焦 点。"我们是从湖北武汉来,先在海口玩两天,等18号封关后再去免税店逛逛。"游客李女士笑着说,她特意将免税购物安排在了封关之后,期待体验新政 带来的变化。像李女士一样抱有期待的游客不在少数, ...