SAN FRANCISCO and SUZHOU, China, June 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) recepto ...

Core Insights - Novo Nordisk generates significant revenue from its GLP-1 injections, Ozempic and Wegovy, which have seen rapid demand growth due to increased prescription rates [1][2] - Combined sales of Ozempic and Wegovy reached DKK 50.1 billion in Q1 2025, representing approximately 66% of the company's total revenues [2][9] - Novo Nordisk holds a leading market position in both the diabetes GLP-1 segment with a 54% market share and the obesity market with a 68.7% market share as of Q1 2025 [2] Sales and Market Position - The company faced supply shortages for Ozempic and Wegovy in H2 2024, which were resolved after ramping up manufacturing, allowing for a potential sales rebound [3][9] - Novo Nordisk has established partnerships with pharmacy benefit managers and telehealth providers to enhance the marketing of Wegovy in the U.S., providing a competitive edge [3] Regulatory Approvals and Indications - New indications for Ozempic and Wegovy are expected to drive sales higher, with Ozempic's label expanded to include cardiovascular risk reduction and kidney failure treatment in T2D patients [4] - Wegovy's label has also been expanded to reduce major adverse cardiovascular event risks, and further indications for preventing heart failure in obesity patients are being pursued [4] Competitive Landscape - The obesity market is projected to grow to $100 billion by 2030, intensifying competition, particularly from Eli Lilly's tirzepatide products [5] - Other companies like Amgen and Viking Therapeutics are advancing their GLP-1-based candidates, increasing competitive pressure in the market [6][7] Stock Performance and Valuation - Year-to-date, Novo Nordisk shares have decreased by 13.6%, underperforming the industry and the S&P 500 [8][10] - The stock is currently trading at a price/earnings ratio of 17.67, above the industry average of 15.63, but below its five-year mean of 29.26 [12] - Earnings estimates for 2025 have improved from $3.80 to $3.84 per share, and for 2026 from $4.60 to $4.64 [15]

REDWOOD CITY, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or the "Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650, the Company's investigational, next-generation oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA). About BMF-650 BMF-650 is an investigational, next-generation oral small-molec ...

Core Insights - Ascletis Pharma Inc. is set to present preliminary studies on its oral GLP-1 receptor agonist ASC30 and weight loss drug candidate ASC47 at the 85th Scientific Sessions of the American Diabetes Association in Chicago [1][5] Group 1: ASC30 - ASC30 is an investigational GLP-1 receptor biased small molecule agonist that can be administered both orally and via subcutaneous injection [3] - It is a new chemical entity with patent protection in the U.S. and globally until 2044 [3] - The first-in-human single ascending dose study will be presented under poster number 750-P on June 22, 2025 [2] Group 2: ASC47 - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist that selectively targets thyroid hormone receptor beta [4] - It is designed to achieve high drug concentrations in adipose tissue, demonstrating unique properties for obesity treatment [4] - The ongoing Phase I clinical trial in combination with semaglutide for obesity treatment began dosing participants in May 2025 [4][2] Group 3: American Diabetes Association (ADA) - The ADA is a leading nonprofit organization focused on diabetes prevention, cure, and improving the lives of those affected by diabetes [5] - The 85th Scientific Sessions will take place from June 20 to 23, 2025, in Chicago, setting the agenda for clinical practice and research innovation [5] Group 4: Ascletis Pharma Inc. - Ascletis is an innovative R&D-driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases [6] - The company covers the entire value chain from drug discovery and development to GMP manufacturing [6] - Ascletis has multiple clinical-stage drug candidates in its metabolic disease pipeline, addressing unmet medical needs globally [7]

Big pharmaceutical companies as well as smaller biotechs have been hoping to score a win in one of today's highest-growth treatment areas: and that's weight loss. Analysts forecast a compound annual growth rate in the double digits from today over the next several years, with the market reaching $100 billion to $130 billion in the early 2030s.Today, Eli Lilly and Novo Nordisk dominate with their well-known treatments: Lilly makes tirzepatide, commercialized as Mounjaro for type 2 diabetes and as Zepbound fo ...

TEL AVIV, Israel, April 28, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications announced today that it has signed a binding term-sheet with Entomus s.r.o. for a license agreement for the development and commercialization of a proprietary Self-Emulsifying Drug Delivery System (SEDDS) formulation that allows absorption of sublingually administrated peptides such as G ...

Eli Lilly shares jumped 15% after a clinical trial of its experimental pill showed it helped patients with Type 2 diabetes lose weight at levels comparable to leading injectable medications like Ozempic.The mid-stage trial results announced on Thursday by the pharmaceutical giant showed that patients taking orforglipron lost an average of 16 pounds — or 7.9% of their body weight — over a 26-week period.That outcome compares favorably to Novo Nordisk’s widely prescribed Ozempic, which helped diabetic patient ...

Financial Data and Key Metrics Changes - Scholar Rock reported an outstanding year in 2024, with significant progress towards regulatory milestones for apitegromab, including the submission of the BLA in the U.S. in January and the upcoming MAA submission in the EU in March [6][36]. - The company anticipates a transformative year in 2025, with plans for a potential launch of apitegromab in the U.S. in Q4 2025 and in the EU in 2026 [37]. Business Line Data and Key Metrics Changes - The SAPPHIRE study demonstrated that apitegromab plus standard-of-care resulted in a 1.8% improvement in the Hammersmith Functional Motor scale compared to placebo, with 30% of patients achieving a 3-point or greater improvement [9][10]. - The cardiometabolic program is on track to share top-line data from the EMBRAZE study in Q2, with the IND filing for SRK-439 planned for Q3 [8][35]. Market Data and Key Metrics Changes - Approximately two-thirds of the 10,000 individuals living with SMA in the U.S. and 35,000 globally have received SMA-targeted therapy, indicating a significant market opportunity for apitegromab as a muscle-targeted therapy [14][15]. - The current market for GLP-1 receptor agonists is projected to generate over $100 billion in sales, highlighting the potential impact of Scholar Rock's cardiometabolic programs [22]. Company Strategy and Development Direction - Scholar Rock aims to establish a neuromuscular franchise starting with SMA, with plans to expand treatment to other neuromuscular disorders [37]. - The company is focused on building a strong commercial team and infrastructure to support the launch of apitegromab, including outreach to payers and scaling the customer-facing team [19][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of apitegromab to transform the standard of care for SMA, emphasizing the importance of addressing progressive muscle weakness [12][15]. - The company is optimistic about the EMBRAZE study and the potential for SRK-439 to enhance weight management therapies by preserving lean muscle mass [35][36]. Other Important Information - Scholar Rock has initiated a disease education campaign called "Life Takes Muscle" to raise awareness about the impacts of muscle weakness in SMA [16][17]. - The company is preparing to offer home infusion services at launch to enhance patient support [19]. Q&A Session Summary Question: Discussion on SAPPHIRE data presentation - Management highlighted the importance of presenting additional data points at the MDA conference, focusing on the consistency and impact across age groups and endpoints [42][43]. Question: Insights on obesity and lean mass preservation - Management clarified that a 20% to 40% improvement in lean mass is considered clinically meaningful, and they are looking for trends in the EMBRAZE study to inform the development of SRK-439 [41][47]. Question: Exploration of additional neuromuscular indications - Management is actively engaging experts to explore adjacent neuromuscular indications and is assessing the unmet need and technical success probability for potential studies [60][63]. Question: Implications of FDA guidance on obesity trials - Management noted that the FDA's guidance reinforces the importance of assessing lean mass loss and that they will continue to follow this closely while developing SRK-439 [69][71]. Question: Comparison of SRK-439 and apitegromab - Management expressed confidence in the profile of SRK-439, indicating it may have greater affinity for the target and could potentially offer advantages in dosing and efficacy [80][82]. Question: Initial payer discussions and pricing strategy - Payers have shown receptiveness to Scholar Rock's innovation, and management expects access to be reflective of the value apitegromab brings to SMA treatment [85][86]. Pricing details are not yet disclosed but are expected to align with other SMA treatments [89].