Workflow
Cardiometabolic diseases
icon
Search documents
MetaVia (NasdaqCM:MTVA) Conference Transcript
2026-02-25 16:17
MetaVia (NasdaqCM:MTVA) Conference February 25, 2026 10:15 AM ET Company ParticipantsHyung Heon Kim - President and CEOModeratorWelcome back, everyone. We have MetaVia Inc., trades on the Nasdaq under the symbol MTVA. It's a clinical stage biotech company focused on transforming cardiometabolic diseases. It's developing the treatment for obesity and vanogliprl for the treatment of MASH. Happy to welcome the president, H.H. Kim. Welcome back to the conference today. We're very much looking forward to hearing ...
MetaVia Builds Comprehensive Global Patent Protection for DA-1726, Securing Exclusive Rights to Novel Obesity and Metabolic Therapy Through 2041
Prnewswire· 2026-02-13 13:31
ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candi ...
Ionis Pharmaceuticals (NasdaqGS:IONS) FY Conference Transcript
2026-01-13 17:17
Summary of Ionis Pharmaceuticals FY Conference Call Company Overview - **Company**: Ionis Pharmaceuticals (NasdaqGS:IONS) - **CEO**: Brett Monia - **Conference Date**: January 13, 2026 Key Industry Insights - Ionis has transitioned from an R&D organization to a fully integrated commercial biotechnology company, achieving its first two independent commercial launches in 2025: **Tringulza** and **Donzera** [4][5] - The company has a robust pipeline with **11 medicines in phase 3 development**, indicating a strong future for product approvals and revenue growth [6] Core Products and Launches - **Tringulza**: Approved for familial chylomicronemia syndrome (FCS), generating **$105 million** in net U.S. product sales in 2025 [13] - **Donzera**: Approved for hereditary angioedema (HAE) prophylaxis, launched in September 2025, with positive early prescription trends [8][9] - **Olezarsen**: Positioned as a new standard of care for severe hypertriglyceridemia (SHTG), with a peak revenue potential now upgraded to **over $2 billion** [17][35] Clinical Achievements - Six positive phase 3 data readouts leading to four approved medicines: Tringulza, Donzera, Wainua, and Qalsody [6] - Olezarsen demonstrated a **72% reduction** in fasting triglycerides and an **85% reduction** in acute pancreatitis event rates at 12 months [15][16] - Zolexarsen for Alexander disease shows unprecedented disease-modifying impact, with plans for NDA submission and launch in the second half of 2026 [21][24] Financial Projections - Anticipated **$4 billion** in potential annual peak product revenue from wholly owned pipeline and **$2 billion** from partner medicines, totaling **over $6 billion** at peak [26] - Expected to achieve cash flow break-even by **2028** with sustained positive cash flow thereafter [26] Market Strategy and Launch Preparations - The launch strategy for Olezarsen in SHTG is based on strong physician enthusiasm and a high unmet need, with a field team of **200 individuals** already hired and trained [33][31] - Pricing strategy for Olezarsen is projected between **$10,000 to $20,000** in the U.S., with ongoing engagement with payers to ensure access [37][38] Risks and Challenges - New product launches inherently carry uncertainty, but the demand for Olezarsen is expected to be strong due to the inadequacy of current treatments for SHTG [36] - The company is preparing for potential challenges in achieving broad access and acceptance among healthcare providers [37] Future Outlook - Ionis is well-positioned for continued growth with a steady cadence of new medicines expected to reach the market, including Olezarsen and Zolexarsen in 2026 [24][25] - The company aims to leverage its strong pipeline and market presence to drive revenue growth and enhance shareholder value [28]
MetaVia to Participate in and Sponsor the 10th Annual MASH-TAG 2026 Conference
Prnewswire· 2025-12-29 13:31
Core Insights - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases [2] - The company is developing two key products: DA-1726 for obesity and vanoglipel for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [2] Product Development - DA-1726 is a novel oxyntomodulin (OXM) analogue acting as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), showing best-in-class potential for weight loss, glucose control, and waist reduction in Phase 1 trials [2] - Vanoglipel is a G-protein-coupled receptor 119 (GPR119) agonist that enhances the release of gut peptides GLP-1, GIP, and PYY, demonstrating positive effects on liver inflammation, lipid metabolism, and glucose control in pre-clinical studies and Phase 2a clinical studies [2] Conference Participation - MetaVia will participate in and sponsor the 10th Annual MASH-TAG 2026 Conference from January 8-10, 2026, in Park City, Utah, with members from its business development and clinical teams attending [1]
MetaVia to Present at Upcoming Investor and Industry Conferences
Prnewswire· 2025-08-26 12:31
Core Insights - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing two key drug candidates: DA-1726 for obesity and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [4] Company Overview - MetaVia is developing DA-1726, a novel oxyntomodulin (OXM) analogue that acts as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), showing potential for superior weight loss and glucose control compared to selective GLP1R agonists [4] - DA-1726 demonstrated best-in-class potential in a Phase 1 multiple ascending dose trial, indicating effectiveness in weight loss, glucose control, and waist reduction [4] - DA-1241 is a G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of gut peptides GLP-1, GIP, and PYY, showing positive effects on liver inflammation, lipid metabolism, and glucose metabolism in pre-clinical studies [4] - In a Phase 2a clinical study, DA-1241 exhibited direct hepatic action alongside glucose-lowering effects [4] Upcoming Events - MetaVia will participate in several upcoming conferences, including: - Wells Fargo Healthcare Conference from September 3-5, where CEO Hyung Heon Kim will attend [7] - H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, featuring a fireside chat and an on-demand presentation available from September 5 [7] - Obesity Science & Innovation 2025 Congress on September 16-17, where Mr. Kim will present an overview focusing on DA-1726 [7] - Fierce Biotech Week from October 7-9, with Mr. Kim's attendance [7]
MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential
Prnewswire· 2025-04-22 12:31
Core Insights - MetaVia Inc. reported promising results from its Phase 1 clinical trial of DA-1726, indicating a dose-dependent response in body weight reduction, with significant differences in BMI and body weight compared to placebo [1][2][4] - DA-1726 demonstrated a maximum weight loss of -6.3% and a mean weight loss of -4.3% at the 32 mg dose, alongside notable reductions in fasting glucose and waist circumference [3][4] - The drug showed a favorable safety profile, with no significant cardiovascular effects observed, and a slight decrease in heart rate across most treatment groups [4][7] Company Overview - MetaVia Inc. is a clinical-stage biotechnology company focused on developing treatments for cardiometabolic diseases, particularly obesity [10] - The company is advancing DA-1726, a dual agonist targeting GLP-1 and glucagon receptors, which aims to improve weight loss outcomes compared to existing therapies [9][10] Clinical Trial Details - The Phase 1 trial was a randomized, double-blind, placebo-controlled study involving 36 subjects, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 [6] - The trial's primary endpoint was to evaluate the safety and tolerability of DA-1726, while secondary endpoints included pharmacokinetic assessments and exploratory metabolic parameters [6] Future Directions - MetaVia plans to conduct a Phase 1 Part 3 study to evaluate DA-1726 in patients who discontinued other GLP-1 agonists, aiming to demonstrate improved tolerability and weight loss outcomes [5] - Additional cohorts will be added to determine the maximum tolerated dose of DA-1726, with expectations of enhanced efficacy at higher doses [5]