Represents potential penetration into ~ 20% of the U.S. institutional market, while broadening access across long-term care and outpatient facilities U.S. losartan market totals $256M annually with 71M prescriptions, creating a significant opportunity for Arbli™ as the first FDA-approved ready-to-use oral suspension COMMACK, NY, Oct. 01, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhance ...

Scienture Holdings, Inc. (NASDAQ:SCNX) announced on Wednesday the formalization of multiple commercial group purchasing organization (GPO) agreements for its new drug, Arbli (losartan potassium) Oral Suspension, 10 mg/mL. The agreements will provide the company access to more than 2,500 healthcare institutions across the U.S., including hospitals, clinics, and long-term care facilities. The company stated that the deal represents a significant step for them as they seek to penetrate an estimated 20% of th ...

Core Insights - Mineralys Therapeutics has completed enrollment in its Phase 2 EXPLORE-OSA trial for lorundrostat, targeting patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with top-line results expected in Q1 2026 [1][2] - The trial aims to address the significant unmet need for effective treatments for patients suffering from OSA and hypertension, as current options are limited and often ineffective [2][3] - Lorundrostat is a selective aldosterone synthase inhibitor designed to reduce aldosterone levels, which are linked to hypertension and related comorbidities [8][9] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and OSA, driven by dysregulated aldosterone [9] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [9] Trial Details - The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension [3] - Participants will receive 50 mg of lorundrostat or placebo, with the primary efficacy endpoint being the change in apnea-hypopnea index (AHI) after four weeks of treatment [3] Disease Context - OSA affects nearly one billion people globally, with 425 million cases classified as moderate-to-severe, and around 80% of adults with OSA remain undiagnosed [4] - Hypertension is a major health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [6] Market Opportunity - Between 30-50% of adults with hypertension have OSA, and this figure rises to 70-80% in those with resistant hypertension (rHTN) [5] - There is a significant opportunity for lorundrostat to address the needs of patients with both hypertension and OSA, particularly given the limitations of current treatment options [2][5]

Core Insights - Scienture Holdings, Inc. has announced a significant rebate agreement with a Pharmacy Benefit Manager (PBM) led Group Purchasing Organization (GPO) to enhance access to its product Arbli, a ready-to-use liquid formulation of losartan, for over 100 million lives [1][5] - Arbli is the first and only FDA-approved oral liquid formulation of losartan in the U.S., designed for patients who require or prefer a liquid alternative for hypertension treatment [2][3] - The U.S. losartan market is valued at approximately $256 million in annual sales, with a prescription volume of 71 million [4][5] Company Overview - Scienture Holdings, Inc. focuses on developing, commercializing, and distributing novel specialty pharmaceutical products to meet unmet market needs [1][11] - The company aims to provide enhanced value to patients, physicians, and caregivers through its innovative products [11] Product Details - Arbli is indicated for the treatment of hypertension in patients over six years old, reducing the risk of stroke and treating diabetic nephropathy in certain type 2 diabetes patients [2][8] - The product is available in a 165 mL bottle as a peppermint-flavored suspension, with a shelf life of 24 months at room temperature [6] Market Position - The rebate agreement is expected to facilitate rapid adoption of Arbli in the competitive $256 million U.S. losartan market, expanding patient access and reducing reimbursement barriers [5] - The product's unique formulation eliminates the need for compounding, ensuring consistent quality and dosing accuracy [3][5]

Core Insights - The Launch-HTN trial of lorundrostat, a novel aldosterone synthase inhibitor, shows significant blood pressure reductions in diverse high-risk patient populations with uncontrolled hypertension [1][2][3] - The trial enrolled 1,083 participants, making it the largest global Phase 3 trial for uncontrolled or resistant hypertension [6][12] - Lorundrostat demonstrated a favorable safety and tolerability profile, with no new safety signals observed [5][8] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related conditions driven by dysregulated aldosterone [1][15] - The company plans to file a New Drug Application (NDA) for lorundrostat in late 2025 or early 2026 [9] Trial Details - The Launch-HTN trial utilized automated office blood pressure measurements and allowed participants to continue existing antihypertensive medications [6][12] - Key demographics of the trial included 29% Black/African American participants, 41% aged 65 or older, and 63% with obesity [2][3] Efficacy Results - Lorundrostat 50 mg showed statistically significant reductions in blood pressure across various subgroups, including a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 [7][12] - The trial results indicated consistent blood pressure lowering effects across high-risk subgroups, addressing a critical unmet medical need [3][4] Safety Profile - The safety outcomes were favorable, with adverse events generally mild or moderate, and a very low incidence of serious drug-related adverse events [5][8] - No significant suppression of cortisol production was observed, and electrolyte changes were modest and reversible [8] Market Context - Hypertension is a leading modifiable risk factor for cardiovascular disease, contributing to over 685,000 deaths in the U.S. in 2022 [10] - Less than 50% of hypertension patients achieve their blood pressure goals with current medications, highlighting the need for new treatments like lorundrostat [11]

Core Insights - The Launch-HTN trial of lorundrostat, a novel aldosterone synthase inhibitor, shows significant blood pressure reductions in diverse high-risk populations with uncontrolled hypertension [1][2][3] - The trial enrolled 1,083 participants, making it the largest global Phase 3 trial for uncontrolled or resistant hypertension [7] - Lorundrostat demonstrated a favorable safety and tolerability profile, with no new safety signals observed [6][9] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related conditions driven by dysregulated aldosterone [1][15] - The company plans to file a New Drug Application (NDA) for lorundrostat in late 2025 or early 2026 [10] Trial Details - The Launch-HTN trial utilized automated office blood pressure measurements and allowed participants to continue existing antihypertensive medications [7][12] - Key demographics included 29% Black/African American, 41% aged 65 or older, and 63% with obesity [2][3] Efficacy Results - Lorundrostat 50 mg showed consistent, statistically significant reductions in blood pressure across various subgroups, including a 16.9 mmHg reduction at Week 6 [8][4] - The trial results indicated that lorundrostat could address critical unmet medical needs in high-risk patient cohorts [3][4] Safety Profile - The safety outcomes were favorable, with adverse events generally mild or moderate, and no significant new safety concerns identified [6][9] - The incidence of serious adverse events leading to discontinuation was very low [9] Future Directions - Mineralys is moving forward with its NDA filing strategy and has scheduled a pre-NDA meeting with the FDA [10] - The company aims to evaluate lorundrostat for potential treatment of chronic kidney disease and obstructive sleep apnea in addition to hypertension [13][15]

Core Insights - Orchestra BioMed announced new data from its AVIM therapy program, indicating sustained blood pressure-lowering effects for years after activation, with reversibility and no rebound hypertension observed [1][4][5] - The AVIM therapy has been presented at the HRX Live 2025 Meeting and published in a peer-reviewed journal, highlighting its potential as a novel treatment for uncontrolled hypertension [2][4] - The company has a strategic collaboration with Medtronic to develop and commercialize AVIM therapy, targeting an estimated global population of over 750,000 patients annually [4][6] Summary by Sections AVIM Therapy Findings - Long-term follow-up of patients treated with AVIM therapy showed sustained reductions in 24-hour ambulatory systolic blood pressure (aSBP) of 8.9 mmHg after an average of 3.6 years [5] - Upon deactivation of AVIM therapy, blood pressure returned to baseline levels without rebound hypertension, demonstrating the treatment's reversibility [5] - Reactivation of AVIM therapy resulted in a significant reduction in aSBP to 124.4 mmHg, indicating reproducibility of the treatment effect [5] Clinical and Mechanistic Data - Dr. Avi Fischer presented data supporting AVIM therapy's role in managing uncontrolled hypertension, emphasizing its sustainability and safety profile [2][4] - The BACKBEAT global pivotal study is currently investigating the efficacy and safety of AVIM therapy in patients with uncontrolled hypertension [2][8] Strategic Collaborations and Market Potential - Orchestra BioMed's partnership with Medtronic aims to commercialize AVIM therapy for patients indicated for a pacemaker, addressing a significant market need [4][6] - AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, representing a potential market of over 7.7 million patients in the U.S. [4][8]

Core Viewpoint - Orchestra BioMed Holdings, Inc. announced favorable hemodynamic effects of AVIM therapy for patients with uncontrolled hypertension, as published in the Journal of the American College of Cardiology: Clinical Electrophysiology [1][2][3] Group 1: AVIM Therapy Findings - AVIM therapy demonstrated statistically significant reductions in systolic blood pressure (SBP) by an average of 17.1 mmHg (RV pacing) and 19.2 mmHg (CSP), compared to 1.7 mmHg with standard pacing [6] - The therapy improved left ventricular hemodynamics, with end-diastolic volume decreasing by 12.6 mL (RV) and 18.6 mL (CSP), and end-systolic volume decreasing by 11.0 mL (RV) and 14.1 mL (CSP) [6] - AVIM therapy also significantly reduced cardiac workload, with stroke work decreasing by 1,596 mL (RV) and 1,870 mL (CSP), compared to 42 mL with standard pacing [6] Group 2: Clinical Implications - The publication of the data in a peer-reviewed journal reinforces the therapeutic rationale behind AVIM therapy, highlighting its potential to deliver differentiated clinical benefits for patients with uncontrolled hypertension [3][7] - AVIM therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk, estimated to be over 7.7 million patients in the U.S. [5][10] - The strategic collaboration between Orchestra BioMed and Medtronic aims to develop AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, a population of over 750,000 patients annually [5][10] Group 3: Research and Development - The BACKBEAT global pivotal study is currently evaluating the safety and efficacy of AVIM therapy in patients with systolic blood pressure above target despite anti-hypertensive medication [10] - The MODERATO II study showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [10] - AVIM therapy is compatible with standard dual-chamber pacemakers and aims to substantially and persistently lower blood pressure [10]

Core Viewpoint - Scienture Holdings, Inc. has announced the shipment of launch quantities of Arbli (losartan potassium) Oral Suspension, marking a significant milestone for the company as it prepares for the commercial launch of this novel product aimed at treating hypertension and related conditions [1][5]. Product Overview - Arbli is the first and only FDA-approved ready-to-use oral liquid formulation of losartan in the U.S. market, designed for patients over 6 years old [2][6]. - The product is indicated for the treatment of hypertension, reduction of stroke risk in patients with hypertension and left ventricular hypertrophy, and treatment of diabetic nephropathy in certain type 2 diabetes patients [8][10]. - Arbli offers a tailored approach for patients who require or prefer a liquid option, ensuring easier and safer dosing without the need for compounding [3][4]. Market Context - Losartan is classified as an angiotensin receptor blocker (ARB) and is one of the most prescribed medications for hypertension, with total annual sales of approximately $276 million and a prescription volume of 69 million in the U.S. as of March 2025 [4]. - The global market for losartan potassium was valued at approximately $1.5 billion in sales in 2024 [4]. Company Strategy - The shipment of Arbli to the distribution center and the receipt of the first order are seen as critical milestones in Scienture's efforts to deliver the product to healthcare providers [5]. - The company emphasizes its commitment to quality by ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) standards [5]. Product Specifications - Arbli is available in a 165 mL bottle as a peppermint-flavored suspension that does not require refrigeration and has a shelf life of 24 months when stored at room temperature [6].

Core Viewpoint - Idorsia Ltd's TRYVIO™ (aprocitentan) has been nominated for the "Best Pharmaceutical Product" category in the 2025 Prix Galien USA awards, highlighting its innovative approach to treating systemic hypertension [1][5]. Company Overview - Idorsia is focused on developing transformative medicines and aims to evolve into a leading biopharmaceutical company with a strong scientific foundation [8][9]. - The company is headquartered near Basel, Switzerland, and has a dedicated team covering all disciplines from research to commercialization [9]. Product Information - TRYVIO™ is the first systemic hypertension treatment targeting a new pathway in over 30 years, functioning as a dual endothelin receptor antagonist (ERA) [3][7]. - It is indicated for use in combination with other antihypertensive drugs to lower blood pressure in adult patients inadequately controlled on existing therapies [3][7]. - TRYVIO™ has shown consistent blood pressure-lowering effects across various patient subgroups, including those with difficult-to-treat hypertension [4]. Health Impact - Hypertension affects an estimated 50% of adults in the US, with half of those patients not well controlled despite medication, leading to increased risks of cardiovascular events [4]. - The treatment of hypertension is critical as it is the number one modifiable risk factor for early morbidity and mortality [4]. Award Significance - The Prix Galien Award is recognized globally as a prestigious honor in biopharmaceutical research, akin to the Nobel Prize, celebrating innovations that improve human health [5].