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Bloomberg· 2025-06-30 15:16
An experimental drug from Mineralys Therapeutics significantly lowered blood pressure in patients with treatment-resistant hypertension in a new study, though several stopped taking it because of side effects. https://t.co/5qpbrE619j ...
MRK's Winrevair Phase III Study in Newly Diagnosed PAH Meets Goal
ZACKS· 2025-06-24 17:20
Key Takeaways MRK's HYPERION study met its primary goal, reducing clinical worsening in newly diagnosed PAH patients. The HYPERION study was stopped early due to strong efficacy seen in the ZENITH study and other data. Winrevair sales reached $280M in Q1 2025, growing 40% sequentially with strong U.S. prescription trends.Merck (MRK) announced that the phase III HYPERION study evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), in newly diagnosed intermediate or high-risk ...
Transforming generational health with story | Dr. Oneeka Williams | TEDxRoxbury
TEDx Talks· 2025-06-23 16:02
[Applause] I am Madam Sodium, hypertension's best friend. My vibe is irresistible. I'll hang with HT till the end. Before the refrigerator, you couldn't live without me. I kept food from spoiling and fed every family. Now I'm in the dog house. It is so unfair. But I am here to stay. I am everywhere. Hypertension is sneaky. So, it's about to be lit. If you don't handle your business, your organs and your body will take the hit. So, you might be wondering, why am I starting this conversation on transforming g ...
Galectin Therapeutics (GALT) Update / Briefing Transcript
2025-06-16 17:00
Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]
Galectin Therapeutics to Host Virtual KOL Event to Discuss Belapectin for Treatment of MASH Cirrhosis and Portal Hypertension
Globenewswire· 2025-06-10 12:56
NORCROSS, Ga., June 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 12:00 PM ET. To register, click here. The event will focus on the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertens ...
Orchestra BioMed Holdings (OBIO) 2025 Conference Transcript
2025-06-05 20:45
Orchestra BioMed Holdings (OBIO) 2025 Conference June 05, 2025 03:45 PM ET Speaker0 Okay, Speaker1 good to go. So thanks everybody for joining for our next session. I'm Matt Taylor, the US Medical Supplies and Devices analyst here at Jefferies. I'm joined by David Hockman, the CEO of Orchestra Lab. Speaker0 Nice to be here. Speaker1 And we have about half an hour for moderated Q and A. And I'll get things rolling here with kind of a high level question. So I think let's start with your business model is rea ...
Brensocatib Shows Consistent Efficacy and Safety Across Three Prespecified Subgroups in New Data from Landmark ASPEN Study
Prnewswire· 2025-05-21 20:05
—    Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE®, TPIP and Health Economics and Outcomes Research   —BRIDGEWATER, N.J., May 21, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, presented 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference, wh ...
Tectonic Therapeutic Presents Complete Results for Positive Phase 1b Clinical Trial of TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF in Late-Breaking Presentation at ESC Heart Failure 2025
Globenewswire· 2025-05-17 14:40
Core Insights - Tectonic Therapeutic, Inc. announced complete results from Part A of the Phase 1b clinical trial of TX45 for patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF) [1][2] - The trial demonstrated that TX45 is well tolerated and showed significant hemodynamic improvements, including a 19.0% reduction in pulmonary capillary wedge pressure (PCWP) and over 30% reduction in pulmonary vascular resistance (PVR) in a specific patient subgroup [2][11] - The results were presented at the European Society of Cardiology Heart Failure 2025 Congress, highlighting the potential of TX45 as a best-in-class therapy for a condition with high morbidity and no approved treatments [3][4] Clinical Trial Results - The Phase 1b trial included a cohort of 19 patients, confirming the tolerability and hemodynamic effects of TX45 previously reported in interim data [2][6] - TX45 treatment resulted in sustained hemodynamic effects for up to 29 days, with improvements in left ventricular function and pulmonary hemodynamics across various left ventricular ejection fractions (LVEF) [4][5] - Specific improvements included a 19.7% reduction in PCWP for patients with LVEF≥50% and an 18.4% reduction for those with LVEF 41-49% [5] Safety Profile - TX45 was well tolerated with no serious or severe adverse events reported during the trial [7][11] - There were no clinically significant changes in vital signs or safety laboratory values, indicating a favorable safety profile for TX45 [11] Mechanism of Action - TX45 is a long-acting Fc-relaxin fusion protein that activates the RXFP1 receptor, providing both pulmonary and systemic vasodilatory effects [13] - The differentiated mechanism of TX45 improves both left ventricular function and pulmonary hemodynamics, particularly beneficial for patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) [11][12] Future Outlook - The topline data from Part B of the Phase 1b study, which will evaluate TX45 in patients with Heart Failure with reduced Ejection Fraction (HFrEF), is expected in the second half of 2025 [3][9] - The ongoing APEX Phase 2 clinical trial is anticipated to provide further insights into the efficacy of TX45 in PH-HFpEF, with topline results expected in 2026 [2][9]
Tectonic Therapeutic (TECX) 2025 Conference Transcript
2025-05-15 17:20
Tectonic Therapeutic (TECX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Hey, everyone. Good morning, and welcome to day three of the twenty twenty five Bank of America Healthcare Conference. And thanks for joining this session with Tectonic Therapeutics. My name is Alex Stranahan. I'm senior biotech analyst at Bank of America. And I'm pleased to introduce Elise Raisin, president and CEO of Tectonic. She'll be running through some slides and going over the company. So with that, Elise, over to you. Spe ...
Galectin Therapeutics Reports Financial Results for the Quarter Ended March 31, 2025 and Provides Business Update
Globenewswire· 2025-05-15 12:00
NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "This quarter, we remained laser-focused on advancing additional analyses for belapectin. I was extremely encouraged by the feedback we received last week at the ...