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New Clinical Data Demonstrate that VIVUS' QSYMIA® in Combination with Digitally Enhanced Lifestyle Interventions (DELI) Leads to Significantly Greater Reductions in Weight and Cardiovascular Risk Compared with DELI Alone in Adults with Obesity
Globenewswire· 2026-01-26 14:00
CAMPBELL, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced the results of a randomized trial (NCT04408586) evaluating the effect of QSYMIA® (phentermine and topiramate extended-release capsules CIV) in combination with DELI compared to DELI plus placebo on weight loss and cardiovascular disease risk outcom ...
Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults, now broadly available across America
Prnewswire· 2026-01-05 13:00
Core Insights - Wegovy pill, the first oral GLP-1 medicine for obesity, is now available, providing a new treatment option for over 100 million Americans living with obesity [1][14] - The pill was approved on December 22, 2025, and is intended for adults with obesity or overweight with weight-related medical issues, in conjunction with a reduced calorie diet and increased physical activity [1][14] - Wegovy pill has demonstrated an average weight loss of approximately 17% if all patients adhered to the treatment, compared to about 3% for placebo [3][15] Product Details - Wegovy pill is available in multiple doses: 1.5 mg (starter dose), 4 mg, 9 mg, and 25 mg, with the starting dose priced at $149 per month [10][11] - The pill is accessible through over 70,000 US pharmacies and select telehealth providers, ensuring affordability and accessibility for patients [6][9] - The OASIS 4 clinical trial showed that 76% of patients taking Wegovy pill achieved a weight loss of 5% or more, compared to 31% for placebo [15] Efficacy and Safety - In the OASIS 4 trial, the average weight loss for Wegovy pill users was about 14% when considering all patients, regardless of adherence, versus 2% for placebo [3][15] - Common adverse reactions reported include nausea, diarrhea, and vomiting, consistent with previous clinical trials of Wegovy [8][15] - Wegovy pill is indicated to reduce the risk of major adverse cardiovascular events in adults with obesity or overweight and established cardiovascular disease [14][22]
2 Beaten-Down Stocks That Could Bounce Back in 2026
Yahoo Finance· 2025-12-31 14:15
Group 1 - The article highlights the potential for above-average market returns by identifying underperforming stocks that may rebound, particularly in the context of a strong overall market performance [1] - Viking Therapeutics and Zoetis are identified as two healthcare stocks that have underperformed in 2025 but may see significant improvements in 2026 [2] - Viking Therapeutics is a clinical-stage biotech company with promising developments in weight management, specifically its investigational GLP-1 anti-obesity medicine VK2735, which is currently in phase 3 studies [4][5] Group 2 - Viking Therapeutics has faced challenges due to profit-taking by investors and high patient dropout rates in mid-stage trials, but the efficacy of VK2735 remains strong, suggesting potential for recovery [6][7] - The company is developing an oral formulation of VK2735, which could enhance its market position in the growing weight loss drug sector [5][6] - Positive clinical and regulatory progress for Viking Therapeutics could lead to a rebound in its stock price as early as next year, making it a stock worth considering [7]
Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies
Prnewswire· 2025-12-25 02:05
Core Viewpoint - Caliway Biopharmaceuticals has submitted an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2 clinical study of CBL-514, a novel drug candidate for weight management, which aims to enhance fat reduction and improve long-term weight maintenance outcomes [1][9]. Company Overview - Caliway Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative small-molecule therapeutics, particularly in aesthetic medicine and other diseases [15]. - CBL-514 is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat without identified systematic safety risks [13]. Clinical Study Details - The Phase 2 study, named CBL-0201WR, will be randomized and placebo-controlled, enrolling approximately 120 subjects with obesity or overweight conditions [2]. - The study will evaluate the efficacy, safety, and tolerability of CBL-514 in combination with Zepbound (tirzepatide) [3][9]. - Efficacy endpoints include changes in abdominal subcutaneous fat volume measured by MRI and body weight changes, with additional assessments of body composition using DEXA [4][9]. Market Context - The global weight management market is experiencing significant growth, driven by the rapid adoption of GLP-1RA weight-loss drugs, with projections indicating it could reach approximately USD 150 billion by 2035, growing at a compound annual growth rate of around 25% [5][12]. - Current GLP-1RA therapies primarily focus on appetite suppression, which may lead to weight regain and adverse metabolic changes post-treatment, highlighting a critical challenge in weight management [6][7]. Mechanism of Action - CBL-514 operates through a distinct mechanism by selectively inducing adipocyte apoptosis and promoting fat metabolism, potentially complementing existing GLP-1RA therapies [10]. - Animal studies have shown that CBL-514 can improve fat composition and support weight maintenance, indicating its potential effectiveness in addressing unmet needs in weight management [11].
After Wegovy, Zepbound Shots, This Eli Lilly Oral Pill Can Help Maintain Weight Loss
Benzinga· 2025-12-18 16:29
Core Insights - The global obesity epidemic is driving pharmaceutical companies to invest in weight management solutions, resulting in increased clinical trials for anti-obesity medications [1] Group 1: Eli Lilly's Orforglipron Trial Results - Eli Lilly's Phase 3 trial of orforglipron demonstrated superior weight maintenance over 52 weeks compared to placebo after initial treatment with high doses of Wegovy or Zepbound [2][4] - At one year, orforglipron met primary and key secondary endpoints, showing effective weight maintenance as an adjunct to a healthy diet and physical activity [3] - Participants switching from Wegovy to orforglipron maintained an average weight difference of 0.9 kg, while those switching from Zepbound maintained an average difference of 5.0 kg [5] Group 2: Safety and Tolerability - The safety profile of orforglipron was consistent with previous studies, with common adverse events being mild-to-moderate gastrointestinal issues [6] - Discontinuation rates due to adverse events were 4.8% for orforglipron from Wegovy, 7.6% for placebo from Wegovy, 7.2% for orforglipron from Zepbound, and 6.3% for placebo from Zepbound [7] - No hepatic safety signals were observed in the trial [7] Group 3: Market Reaction - Eli Lilly's stock rose by 2.20% to $1064.73, nearing its 52-week high of $1111.99 [8]
2 Reasons I Wouldn't Touch BioAge Labs Stock With a 10-Foot Pole
The Motley Fool· 2025-12-13 15:15
Core Viewpoint - BioAge Labs is a small biotech company that has seen a significant increase in its stock price due to clinical progress in weight management, but it remains unattractive for long-term investors due to high risks associated with its clinical stage and intense competition in the market [1][7]. Group 1: Company Overview - BioAge Labs' shares have increased by 122% year to date, currently priced at $12.88 with a market cap of $462 million [5][6]. - The company is developing a single candidate, BGE-102, which is still in phase 1 clinical trials, making it a high-risk investment [4][3]. Group 2: Clinical Development - BioAge Labs has only one candidate in clinical trials, which is in phase 1, indicating a lack of advanced clinical data compared to competitors [4][3]. - Positive interim results for BGE-102 have been reported, but the overall risk remains high due to the early stage of development [4]. Group 3: Market Competition - The weight management market is expected to grow rapidly, attracting many major pharmaceutical companies and smaller firms, increasing competition for BioAge Labs [6][7]. - Success for BioAge Labs will depend on the safety and efficacy of BGE-102, but uncertainty remains regarding its ability to compete effectively in the anti-obesity market [7]. Group 4: Investment Alternatives - Other biotech companies, such as Viking Therapeutics, are further along in clinical trials, having completed phase 2 and currently in phase 3 for their lead candidate, VK2735, presenting a less risky investment option [8]. - Investors may face the risk of BioAge Labs shares becoming worthless in the future, suggesting a cautious approach towards investment in this company [9].
Pfizer's CEO Sends a Warning to Eli Lilly. Is the Stock a Buy?
The Motley Fool· 2025-11-18 02:10
Core Insights - Pfizer is making significant moves in the weight management market, which is expected to grow rapidly in the next decade, potentially rewarding leading companies handsomely [1][2] - The acquisition of Metsera for $7 billion, with potential milestone payments bringing the total to $10 billion, positions Pfizer as a strong contender in the weight management space [3][4] - Pfizer's CEO, Albert Bourla, expressed confidence in the company's ability to succeed in the obesity market, drawing parallels to past successes with drugs like Lipitor and COVID products [7] Company Developments - Pfizer's acquisition of Metsera indicates its commitment to entering the weight management market, especially after competing with Novo Nordisk for the deal [3][4] - Metsera's leading candidate, MET-097i, has shown promising results in clinical trials, indicating potential for substantial weight loss and good tolerability [6] - Pfizer plans to launch its first anti-obesity drug by the end of 2028, although Eli Lilly currently holds a significant lead with existing products on the market [8] Competitive Landscape - Eli Lilly is currently the leader in the weight management market with its product Zepbound, which has seen exceptional sales growth [8][11] - Eli Lilly has several promising candidates in its pipeline, including orforglipron and retatrutide, which are expected to enhance its competitive position [9][10][11] - Despite Pfizer's efforts, Eli Lilly's established presence and upcoming product launches may allow it to maintain its leadership in the anti-obesity market for the foreseeable future [11] Financial Outlook - Pfizer's recent financial performance has been underwhelming, with concerns about the impending patent cliff for its top growth driver, Eliquis [13] - However, the acquisition of Metsera and the potential success in the weight management sector could help Pfizer rebound [14] - The company also has a strong dividend program, which may attract investors despite current challenges [15]
Mangoceuticals Partners with Eli Lilly and Novo Nordisk to Deliver Affordable Access to Zepbound and Wegovy for Obesity Management
Globenewswire· 2025-11-13 12:00
Core Insights - Mangoceuticals, Inc. has launched two new programs, MangoRx Direct and PeachesRx Direct, providing direct access to GLP-1 medications Zepbound® and Wegovy® through a secure telemedicine platform [1][2][3] Group 1: Company Overview - Mangoceuticals focuses on health and wellness products, utilizing telemedicine to offer services under the brands MangoRx and PeachesRx [1] - The company aims to simplify and sustain weight-loss treatment, offering a medication management membership for $99 per month, which includes unlimited telehealth visits and lifestyle coaching [3] - The company is positioned to address the obesity epidemic affecting 42% of U.S. adults, which costs the healthcare system over $210 billion annually [4] Group 2: Product Offerings - The GLP-1 medications will be available through Eli Lilly's LillyDirect® and Novo Nordisk's NovoCare Pharmacy, with virtual consultations and personalized treatment plans provided [2] - Medications are priced starting at $499 per month, with options for home delivery or local pharmacy pickup, and no insurance is required [3] Group 3: Market Context - The launch aligns with the White House's initiative to reduce government pricing for GLP-1 medications to $245 per month and offer $50 copays for Medicare patients with obesity starting mid-2026 [3] - The company believes it can serve millions of individuals seeking effective and affordable weight management solutions [4]
WeightWatchers Collaborates With Amazon Pharmacy to Increase Medication Delivery Speed, Convenience and Savings For Members
Globenewswire· 2025-10-20 10:30
Core Insights - WW International, Inc. has announced a collaboration with Amazon Pharmacy to enhance access to weight management medications for WeightWatchers Clinic members [1][5] - The partnership aims to simplify the process of obtaining medications, providing real-time availability, automatic savings, and reliable home delivery [2][3] Collaboration Details - WeightWatchers Clinic members can now check medication availability, compare delivery times, and utilize Amazon Pharmacy for prescriptions, improving convenience [2][4] - Amazon Pharmacy will automatically apply manufacturer-sponsored savings at checkout, eliminating the need for manual coupon entry [3][4] Service Enhancements - The collaboration leverages Amazon's logistics for fast and reliable delivery, including free two-day shipping for Prime members and same-day delivery in eligible areas [3][4] - WeightWatchers emphasizes a holistic approach, combining medication access with nutrition programs and community support to enhance member outcomes [6] Performance Metrics - A recent study indicated that WeightWatchers Clinic members lost an average of 21% of their body weight over 12 months, surpassing results from other telehealth providers and clinical trials [6] Company Background - WeightWatchers is recognized as a leader in science-backed weight management, with over 60 years of experience and a comprehensive support system [7] - The company offers a personalized approach that includes clinical interventions and a global network of coaches, aiming to provide sustainable health outcomes for its members [7]
This Healthcare Stock's Bad News Could Create a $10 Billion Opportunity for Competitors
The Motley Fool· 2025-08-17 11:15
Core Viewpoint - Eli Lilly's recent setbacks in the oral GLP-1 market present a potential buying opportunity despite a decline in share price [1][8][14] Company Analysis - Eli Lilly has faced challenges with its investigational oral GLP-1 candidate, orforglipron, which did not meet market expectations in a phase 3 study for weight management, leading to a significant drop in share price [1][8] - The company remains a leader in the GLP-1 market, with its product Zepbound generating billions in quarterly sales, primarily competing with Novo Nordisk's Wegovy [4][12] - Despite the recent setback, Eli Lilly's financial results are strong, and it has a robust pipeline with potential blockbusters in oncology and immunology [14] Industry Analysis - The oral GLP-1 market is projected to reach $20 billion by 2030, with a significant portion potentially coming from weight management sales due to the growing popularity of anti-obesity medicines [6][7] - Currently, there is only one oral GLP-1 drug approved by the FDA, Rybelsus, which generated $3.6 billion in sales last year, indicating a large untapped market for oral alternatives [6][5] - Novo Nordisk stands to benefit from Eli Lilly's setbacks, as it has initiated phase 3 studies for its investigational weight loss medicine, amycretin, which could outperform orforglipron [12][13]