The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system […]
Reinforces Role of AI-Powered Quantitative Coronary Plaque AssessmentMOUNTAIN VIEW, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced the American College of Cardiology (ACC) and the American Heart Association (AHA) published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management. The ACC’s consensus recommendations, published this week in JACC: Cardiovascular Imaging, highlight the importance of quantitative plaque assessment and underscore the benefits of adopting AI-powered Heartflow Plaque Analysis for personalized, precision cardiac care.1 The ACC statement elevates plaque analysis from an emerging technology to a defined clinical consideration in CAD management, outlining appropriate patient selection and best practices for interpreting and reporting. In direct alignment with the ACC’s call for rigorous quality assurance, reproducible results, and “human in the loop” analysis, Heartflow delivers a differentiated standard for clinical plaque quantification by combining AI-driven analysis with expert quality review. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication.2 This rigor, together with Heartflow’s commitment to standardized reporting and advanced algorithmic approaches such as adaptive thresholds, reflects a level of validation and quality oversight consistent with ACC guidance. The AHA statement, published recently in Circulation, reinforces plaque burden and composition as central in managing nonobstructive CAD.3 The expert authors emphasize that patients with nonobstructive CAD should not be considered low-risk, recognizing that coronary plaque burden, extent, and composition are major determinants of outcomes. Earlier this year, a commission perspective published in The Lancet called for a fundamental shift in managing CAD, urging clinicians to focus on identifying and managing plaque early, before the opportunity for prevention has been lost.4 Together, the scientific statements from ACC and AHA reinforce that broader paradigm shift toward understanding plaque burden, not just artery obstruction, in modern CAD management. “The ACC and AHA scientific statements address an important need by providing evidence-based consensus recommendations for clinicians and imagers, solidifying coronary CTA-based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD,” said Ron Blankstein, M.D., writing committee member for both the ACC and AHA statements, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These statements highlight the limitations of current methods to assess risk based on risk factors or stenosis severity alone. Integrating AI-powered technology into clinical practice using ACC and AHA’s guidance can help clinicians move beyond diagnosing blockages, toward predicting and preventing major cardiovascular events.” Both the ACC and AHA scientific statements support the use of quantitative coronary plaque analysis to identify high-risk patients, enabling the immediate and appropriate initiation of preventive treatment. Heartflow Plaque Analysis addresses the need to quantify disease following visual detection of plaque, and is delivered instantly upon order to maintain seamless clinical integration and enable timely clinical decision-making. “The ACC and AHA scientific statements signal growing consensus that plaque assessment is essential for risk stratification, prevention, and long-term CAD management. Heartflow Plaque Analysis enables more precise risk stratification for personalized, preventive treatment plans,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The expert guidance articulates the need for rigorous validation and standardization, which Heartflow is uniquely positioned to address, given our technology and quality systems already align with these stringent recommendations. We are energized by the opportunity to continue collaborating with clinicians as a catalyst to redefine and improve precision cardiovascular care.” The ACC and AHA’s scientific statements reflect a growing body of clinical evidence further substantiating the prognostic significance of Heartflow Plaque Analysis. A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death.5 The company is generating additional real-world evidence through the DECIDE registry, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Plaque Analysis with Plaque Staging* was added compared to their management based on CCTA alone.6 About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com 1 Chandrashekhar Y, Blankstein R, Shaw L. et al. Quantitative Coronary Plaque Analysis in Clinical Practice: 2025 ACC Scientific Statement: A Report of the American College of Cardiology. J Am Coll Cardiol Img. doi: 10.1016/j.jcmg.2025.11.0082 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.3 Slipczuk L, Blankstein R, Bucciarelli-Ducci C. et al. State of the art: evaluation and medical management of nonobstructive coronary artery disease in patients with chest pain: a scientific statement from the American Heart Association. Circulation. 2025;152:e443–e466. doi: 10.1161/CIR.00000000000013944 Zaman, Sarah et al. The Lancet Commission on rethinking coronary artery disease: moving from ischaemia to atheroma. The Lancet. 2025;405,10486:1264-1312. Doi: 10.1016/S0140-6736(25)00055-85 Fairbairn et al. AHA 2025.6 DECIDE Registry. Rinehart, et al., presented at SCCT 2025.*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.
SHANGHAI and SANTA BARBARA, Calif., Dec. 17, 2025 /PRNewswire/ — Rona Therapeutics, a global leader in next-generation RNAi medicines, today announced the submission of RN5681 to the Australian Human Research Ethics Committee (HREC), advancing the company’s first bi-valent siRNA into…
Approval Triggers Milestone Payment of $7.5 Million from Sanofi; Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise capacity and symptoms. Under the terms of its license and collaboration agreement with Cytokinetics, Sanofi has exclusive rights to develop and commercialize MYQORZO for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. The approval of MYQORZO in oHCM in China triggers a $7.5 million milestone payment from Sanofi to Cytokinetics. Cytokinetics remains eligible to receive up to $142.5 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of MYQORZO in Greater China. MYQORZO is only approved for use in China. Aficamten is currently under regulatory review in the U.S, where the FDA is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. On December 12, 2025 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending marketing authorization in the European Union (EU) for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. About MYQORZO® (aficamten) MYQORZO® (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties.1 MYQORZO was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM. In preclinical models, MYQORZO reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for MYQORZO is assessing its potential as a treatment that improves exercise capacity as measured by peak oxygen uptake (pVO2) and relieves symptoms in patients with HCM. MYQORZO was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients symptomatic obstructive hypertrophic cardiomyopathy (HCM). MYQORZO received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China. Aficamten is also currently under clinical investigation in ACACIA-HCM, a Phase 3 trial in patients with non-obstructive HCM and CEDAR-HCM, in a pediatric population with oHCM. Aficamten has not been deemed safe or effective for use in either of these patient populations. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the U.S.2,3,4 Two-thirds of patients with HCM have obstructive HCM (oHCM), where the thickening of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction, while one-third have non-obstructive HCM (nHCM), where blood flow isn’t impacted, but the heart muscle is still thickened. People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.5 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.6 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company building on its over 25-years of pioneering scientific innovation in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. MYQORZO® (aficamten), the company’s cardiac myosin inhibitor, is approved for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) in China, and under regulatory review in the U.S. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization in the European Union for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction, ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. About the Sanofi and Cytokinetics Collaboration In 2024, Sanofi acquired exclusive rights to develop and commercialize MYQORZO® (aficamten) from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Previously, CORXEL acquired the rights to develop and commercialize MYQORZO in Greater China from Cytokinetics in accordance with Cytokinetics’ global registration programs. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by any date, if ever, or our earning or receiving any milestone payments or specific quantum of royalties from commercialization of MYQORZO in Greater China. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, the commercialization activities of Sanofi, the actions of regulatory activities, and the results of our on-going clinical trials. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in China. References: Chuang C, Collibee S, Ashcraft L, et al. Discovery of Aficamten (CK-274), a Next-Generation Cardiac Myosin Inhibitor for the Treatment of Hypertrophic Cardiomyopathy. J Med Chem. 2021;64(19):14142–14152. https://doi.org/10.1021/acs.jmedchem.1c01290CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575Symphony Health 2016-2021 Patient Claims Data DoF;Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654.Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21 Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
In this free webinar, learn about the advantages of leveraging EPQT and AI-powered data quality in early phase QT assessment. The featured speakers will share considerations for determining whether early phase QT data may support regulatory waiver of a stand-alone QT study. Attendees will…
DENVER–(BUSINESS WIRE)–Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the Global CVCT Scientific Program 2025 in Washington, DC. “These findings fundamentally change how we should assess cardiac risk in patients by addressing the historically overlooked risk of non-obstructive coronary artery disease,” said Andrew […]
First FDA approved treatment in 30+ years for more than 2 million Americans with PSVT Novel nasal spray designed to rapidly resolve episodes of PSVT and restore sinus rhythmFDA approval in PSVT enables development of AFib-RVR under sNDA pathwayMilestone well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financingConference call and webcast December 15, 8:00 a.m. ET MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026. CARDAMYST nasal spray is a novel and rapid-acting calcium channel blocker delivered when needed to treat often highly symptomatic and unpredictable episodes of PSVT. With CARDAMYST, adults with PSVT can be prepared wherever and whenever episodes occur, providing them with active management and a greater sense of control of their condition. “CARDAMYST is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “The FDA approval of CARDAMYST is a watershed moment for Milestone and a gratifying event for our team members, patients, clinical investigators, and health care providers who participated in the development program, all of whom I sincerely thank for their dedication, counsel, and collaboration toward this important achievement.” “Some people with PSVT have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits,” said James Ip, M.D., FACC, FHRS, an etripamil investigator. “CARDAMYST will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services.” CARDAMYST Clinical Data The FDA approval of CARDAMYST is supported by a robust clinical trial program based on safety data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of CARDAMYST vs. placebo, published in The Lancet in 2023. In clinical studies, participants using CARDAMYST were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered CARDAMYST (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR = 2.62; p
TRICAV II will evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System WILMINGTON, Del., Dec. 12, 2025 /PRNewswire/ — P&F USA, Inc., the U.S. subsidiary of heart valve manufacturer P&F Products and Features GmbH, today announced that the U.S. Food and…
– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors – RADNOR, Pa., Dec. 12, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the manuscript highlighting the Company’s Phase 3 Launch-HTN clinical trial evaluating lorundrostat for the treatment of uncontrolled or treatment-resistant hypertension, was featured in JAMA’s inaugural “Research of the Year Roundup,” a curated collection of the most impactful studies published between October 2024 and September 2025. In introducing this first-ever “Research of the Year Roundup,” JAMA noted that its top editors were asked to nominate their favorite studies based on their importance and impact. The list of nine selected studies spans diverse topics – from hypertension, to dementia and the use of artificial intelligence (AI) – and, according to JAMA, reflects clinical conditions that are of great importance to patients, clinicians, and to the public health community. Among this select group, JAMA profiled Mineralys’ Launch-HTN trial under the banner “New Hope for Treatment-Resistant Hypertension.” The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor (ASI), when added to existing background antihypertensive treatment in 1,083 participants with uncontrolled or treatment-resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure (BP) with a favorable safety and tolerability profile. Launch-HTN recruited a diverse population as reflected in the high proportion of female, Black or African American and elderly participants in the trial. JAMA highlighted several key findings from the Launch-HTN trial: Lorundrostat’s mechanism targets excess aldosterone production, a root cause of hypertension. Unlike existing aldosterone blockers that obstruct the hormone receptor, lorundrostat inhibits the enzyme that produces aldosterone itself, offering a novel mechanism of action.When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in automated office blood pressure (AOBP) with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) that was sustained with a reduction of 19.0 mmHg at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen.Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial, noting that while hyponatremia, hyperkalemia, and reduced kidney function occurred more frequently in the treatment arm, discontinuation rates due to adverse events remained below 1%. In the “Research of the Year” article, JAMA’s Executive Editor Gregory Curfman, MD, emphasized the importance of advancing care for the large segment of patients whose hypertension remains uncontrolled despite being on multiple medications, noting that lorundrostat “opens a new approach to the treatment of uncontrolled hypertension, which may affect up to 40% of patients.” The article also points out that, until now, patients have had limited options despite facing heightened cardiovascular risks, including myocardial infarction, stroke, or chronic kidney disease. “We are honored that JAMA has recognized Launch-HTN as one of its Research of the Year studies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “This acknowledgment underscores the significant clinical need faced by millions of people living with uncontrolled or treatment-resistant hypertension. The results of Launch-HTN reflect the dedication of our investigators, participants, and team, and reinforce our commitment to bringing forward a differentiated therapy to address a root cause of hypertension.” The manuscript titled, “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension” was featured in JAMA’s June 30, 2025 issue. Lorundrostat continues to be evaluated in the ongoing Transform-HTN open-label extension trial, which is assessing long-term safety and durability of response. The Company also completed enrollment in Explore-OSA, the first trial to evaluate lorundrostat in participants with hypertension and moderate-to-severe OSA. Lorundrostat is the only ASI being studied to address both apnea-hypopnea index (AHI) and nighttime systolic blood pressure in this population, with data anticipated in the first quarter of 2026. About Launch-HTNLaunch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Hypertension Having sustained, elevated blood pressure (or hypertension) (BP) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About MineralysMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking StatementsMineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com
Final Decision from European Commission Expected in Q1 2026 SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026. “We are pleased with CHMP’s positive recommendation based on the robust clinical evidence from SEQUOIA-HCM that demonstrated the safety and efficacy of MYQORZO in patients with oHCM, and we are accelerating commercial readiness activities accordingly,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Given the urgency to bring new treatment options to the European oHCM patient community, pending the final European Commission decision, we look forward to making MYQORZO available to patients in Europe.” “This positive opinion from the CHMP is an important milestone toward bringing a new treatment option with distinct attributes to patients with oHCM,” said Iacopo Olivotto, M.D., Head of the Cardiomyopathy Center and Professor of Cardiovascular Medicine at the University of Florence, Italy. Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review. About SEQUOIA-HCM The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1 The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 ml/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 ml/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002). The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF). Treatment emergent serious adverse events occurred in 5.6% and 9.3% of patients on MYQORZO and placebo, respectively. Core lab echocardiographic LVEF was observed to be
