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AstraZeneca's Baxdrostat Meets Goal in Resistant Hypertension Study
ZACKS· 2025-10-08 16:15
Key Takeaways AstraZeneca reported positive phase III Bax24 data in patients with resistant hypertension.Baxdrostat achieved a significant drop in 24-hour average systolic blood pressure versus placebo.Baxdrostat was well tolerated, and AstraZeneca plans to share results with global regulators.AstraZeneca (AZN) announced positive top-line data from the phase III Bax24 study evaluating the safety, tolerability and efficacy of its investigational candidate, baxdrostat, in patients with resistant hypertension. ...
AstraZeneca (AZN) 2025 Conference Transcript
2025-08-31 18:02
Financial Data and Key Metrics Changes - AstraZeneca presented a risk-adjusted total revenue ambition of EUR 80 billion by 2030, indicating significant progress since their Investor Day in May, supported by positive Phase III readouts [7][8]. - The company remains confident in its growth trajectory, with several exciting readouts expected in the next six to twelve months across various therapeutic areas [7]. Business Line Data and Key Metrics Changes - AstraZeneca is focusing on addressing unmet needs in cardio-renal and cardiometabolic diseases, with a robust pipeline of novel therapies and combination approaches [9][10]. - Positive Phase II data for laroprostat, an oral PCSK9 inhibitor, has been reported, and three Phase III trials in dyslipidemia have been initiated [10][11]. Market Data and Key Metrics Changes - In the U.S., over 20 million patients treated with two or more antihypertensive medicines remain uncontrolled, with 85% managed by primary care physicians and cardiologists [34]. - In the EU5, China, and Japan, more than 75 million patients have uncontrolled hypertension despite receiving at least two antihypertensive medicines [35]. Company Strategy and Development Direction - AstraZeneca aims to transform care across cardio-renal and cardiometabolic diseases, leveraging its existing foundation in primary and specialty care to maximize the commercial potential of Bexarostat [10][35]. - The company is initiating the Phase III BAX PA trial in primary aldosteronism and has ongoing trials evaluating Bexarostat in chronic kidney disease and heart failure [36][37]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the uptake of Bexarostat in treatment-resistant hypertension, anticipating a faster penetration in this population before expanding to uncontrolled patients [44][46]. - The company is confident in its ability to lead the aldosterone synthase inhibitor market, with expectations of significant growth driven by new innovations and updated treatment guidelines [67][68]. Other Important Information - Bexarostat demonstrated a significant reduction in systolic blood pressure in clinical trials, with a favorable safety profile and low rates of hyperkalemia [30][31]. - The company is conducting additional analyses to confirm the benefits of Bexarostat's long half-life for 24-hour blood pressure control [31]. Q&A Session Summary Question: What is the commercial potential for both uncontrolled and treatment-resistant hypertension? - AstraZeneca expects a good uptake in the treatment-resistant population first, with a clear unmet medical need in both groups [44][45]. Question: How do you see the market dynamics for treatment-resistant and uncontrolled hypertension? - The market is expected to grow significantly, with AstraZeneca aiming for market leadership despite competition from new therapies [67][68]. Question: What were the reasons for screen failures in the trial? - Most screen failures occurred because patients did not meet entry criteria based on their blood pressure measurements during the trial [63][64]. Question: What is AstraZeneca's estimate for the overall aldosterone synthase inhibitor market? - AstraZeneca believes Bexarostat will be a $5 billion plus opportunity, aiming for a significant share of the growing market [66][67]. Question: How does Bexarostat compare to existing MRAs in terms of safety and efficacy? - Bexarostat is expected to provide a cleaner profile with fewer side effects compared to existing MRAs, which have limited usage due to adverse effects [75].
AstraZeneca Meets All Key Goals in Phase III Hypertension Study
ZACKS· 2025-07-15 13:36
Core Insights - AstraZeneca (AZN) reported positive results from a late-stage study of its investigational candidate, baxdrostat, for patients with uncontrolled hypertension [1][4] - The study demonstrated significant reductions in mean seated systolic blood pressure (SBP) at both 1 mg and 2 mg doses compared to placebo, meeting the primary endpoint [2][4] - Baxdrostat is a potential first-in-class oral aldosterone synthase inhibitor, addressing a significant unmet medical need in hypertension management [2][6] Study Results - The phase III BaxHTN study met all key secondary endpoints, including reductions in seated SBP in resistant hypertension patients and improvements in seated diastolic blood pressure [3][4] - The candidate was well-tolerated, exhibiting a favorable safety profile across the study population [6][4] - AstraZeneca's shares have increased by 9.5% year-to-date, contrasting with a 0.9% decline in the industry [3] Future Plans - AstraZeneca plans to present detailed data from the phase III study at a medical conference in August 2025 and share results with global regulatory authorities [7] - The company is also evaluating baxdrostat for primary aldosteronism and in combination with dapagliflozin for chronic kidney disease and heart failure prevention in hypertensive patients [9] Acquisition and Financial Implications - Baxdrostat was acquired through AstraZeneca's purchase of CinCor Pharma in 2023, with former CinCor shareholders eligible for a contingent value right of $10 per share upon new drug application submission [8]
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Globenewswire· 2025-06-17 05:00
Core Insights - Vivoryon Therapeutics N.V. reported its Q1 2025 financial results and operational progress, focusing on the development of varoglutamstat for kidney diseases, particularly diabetic kidney disease (DKD) [2][3] Financial Performance - Revenues for Q1 2025 were zero, consistent with Q1 2024 [14] - Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in Q1 2025 from EUR 7.4 million in Q1 2024, primarily due to lower third-party expenses [14][16] - General and administrative expenses were EUR 1.3 million in Q1 2025, down from EUR 2.1 million in Q1 2024 [16] - Net loss for Q1 2025 was EUR 2.5 million, compared to EUR 9.3 million in Q1 2024 [17] - Cash and cash equivalents as of March 31, 2025, were EUR 7.0 million, down from EUR 9.4 million as of December 31, 2024 [17] Clinical Development - The company is advancing varoglutamstat in kidney disease, with a planned Phase 2b study in DKD as a priority for 2025 [9] - A meta-analysis confirmed that varoglutamstat at 600mg twice daily significantly improved eGFR kidney function, with effects sustained until week 96 [7] - Preclinical data showed a synergistic effect of varoglutamstat in combination with SGLT-2 inhibitors, indicating potential for enhanced treatment regimens [5][6] Intellectual Property - A new composition of matter patent for varoglutamstat was granted in the U.S., providing exclusivity through 2044, with potential extensions [10] - The company is actively pursuing additional patents related to varoglutamstat and its applications in kidney disease [10] Corporate Developments - Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors for up to EUR 15 million in ordinary shares over the next 36 months, enhancing financial flexibility [12] - Julia Neugebauer was appointed as Chief Operating Officer, effective May 1, 2025, to oversee investor relations and corporate functions [13] Pipeline Updates - The company has nominated a new candidate, VY2149, a next-generation QPCT/L inhibitor, expected to enter late-stage preclinical development [11]