Coronary/Structural Heart

Tissue Dynamics and Galmed Unveil Unknown Metabolic Pathway for Cardiac Fibrosis and Heart Failure which Supports the Development of Aramchol for Cardiac Fibrosis

– Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using a human cardiac organoid model, revealing disease biology that is not accessible through conventional animal models. – In inflammatory human cardiac organoids, the combination of…

New analysis of Idorsia’s aprocitentan demonstrates significant and sustained reduction in albuminuria in patients with uncontrolled / resistant hypertension

The findings demonstrate that aprocitentan may help reduce the risk of kidney disease progression, cardiovascular events, and mortality in patients with resistant hypertension. Allschwil, Switzerland – June 01, 2026Idorsia Ltd (SIX: IDIA) announces new analyses from the Phase 3 PRECISION study demonstrating that aprocitentan, Idorsia’s dual endothelin receptor antagonist, significantly reduces albuminuria and improves albuminuria risk categories in patients with resistant hypertension. The data were presented by Prof. Markus Schlaich at the 35th Congress of the European Society of Hypertension (ESH). The oral presentation, entitled “Effect of the Dual Endothelin Receptor Antagonist Aprocitentan on Albuminuria”, underscores the role of endothelin pathway inhibition not only in blood pressure control, but also in addressing kidney-related risk in this high-risk population, further supporting the evidence presented in Hypertension titled “Aprocitentan in Patients with Chronic Kidney Disease and Resistant Hypertension”. Addressing a critical unmet need in resistant hypertensionHypertension remains the leading modifiable risk factor for cardiovascular disease and premature death, with patients whose blood pressure is difficult to control facing even higher risks of stroke, myocardial infarction, heart failure, and kidney disease. In resistant hypertension in particular, chronic kidney disease and type 2 diabetes are common and contribute to poor long-term outcomes. Albuminuria, measured as urine albumin-creatinine ratio (UACR), is a well-established biomarker of kidney damage and is strongly associated with increased cardiovascular morbidity and mortality, and more rapid progression towards kidney failure. Albuminuria is more commonly observed in conditions such as Type 2 diabetes and hypertension, as well as older age. Changing to a lower risk category, as a result of lowering albuminuria is therefore an important therapeutic objective beyond blood pressure lowering. Potential to improve long-term renal and cardiovascular outcomesBy lowering albuminuria and shifting patients to lower risk categories, aprocitentan may help reduce the risk of kidney disease progression and cardiovascular risk in patients with difficult-to-control hypertension. Prof. Markus Schlaich, MD, FAHA, FESC, ISHF, The University of Western Australia, Perth, and lead investigator in the PRECISION study commented:“These data represent a major step forward in the management of difficult-to-control hypertension. By targeting the endothelin pathway, aprocitentan not only delivers robust and sustained blood pressure reductions, but also drives clinically meaningful improvements in albuminuria – an established marker of kidney and cardiovascular risk. The ability to lower albuminuria risk category in nearly half of these high-risk patients underscores the potential of aprocitentan to change the treatment paradigm and deliver tangible long-term benefits for patients who remain inadequately controlled on current therapies, particularly those in whom treatment decisions are complicated by the risk of hyperkalemia.” New PRECISION analysis: meaningful reductions in albuminuriaThe new analysis evaluated the effect of aprocitentan in 730 patients with confirmed resistant hypertension receiving at least three antihypertensive agents, including a diuretic.Key findings include: Rapid and substantial reductions in UACR: In patients with baseline microalbuminuria (UACR 30–300mg/g) and macroalbuminuria (UACR >300mg/g), aprocitentan significantly reduced UACR at Week 4 compared with minimal changes on placebo. Sustained long-term effects: By Week 36, treatment with aprocitentan 25 mg reduced mean UACR: From 77.5 mg/g to 34 mg/g in patients with microalbuminuriaFrom 860.2 mg/g to 286.7 mg/g in patients with macroalbuminuria Early improvement/normalization in albuminuria risk category: As early as Week 4: Up to 45% of patients with microalbuminuria achieved normal albumin levels with aprocitentanUp to 39% of patients with macroalbuminuria improved to a lower risk category At Week 36, approximately 46% of patients with baseline micro- or macroalbuminuria achieved a lower albuminuria risk category Stable eGFR in both microalbuminuria and macroalbuminuria eGFR did not decline but remained stable, confirming the renal protective effect of aprocitentan Preservation of normal kidney status: More than 92% of patients with normal albumin levels at baseline remained within the normal range during treatment. Targeting endothelin: a novel and clinically meaningful mechanismIdorsia’s Chief Scientific Officer & Head of Research, Martine Clozel, also spoke at the event with a presentation entitled “From dream to reality: improving lives though endothelin-related innovations”. Aprocitentan, Idorsia’s dual endothelin receptor antagonist approved as TRYVIO™ in the US and as JERAYGO™ in Europe, is the first therapy of its kind to target the endothelin pathway in systemic hypertension. Endothelin is a key driver of vasoconstriction, inflammation, fibrosis, and organ damage, and is often upregulated in patients with resistant hypertension and kidney disease. The findings from this analysis reinforce the central role of endothelin in both the development and consequences of hypertension, including the potential to reduce kidney damage progression and long-term cardiovascular risk. Unlike therapies targeting the renin–angiotensin–aldosterone system (RAAS) pathway, which may be associated with electrolyte disturbances such as hyperkalemia, endothelin receptor antagonism with aprocitentan has not demonstrated an increased risk of hyperkalemia. Building on proven blood pressure efficacyThe albuminuria data complement previously reported results from PRECISION, where aprocitentan demonstrated: Rapid, double-digit reductions in systolic blood pressureSustained efficacy over 48 weeksConsistent effects across office and ambulatory measurementsConsistent blood pressure reductions across key patient subpopulations, including those with high-risk comorbidities Importantly, the treatment effect was maintained in patients with common and clinically relevant comorbidities, including type 2 diabetes, obesity (including severe obesity), chronic kidney disease, and congestive heart failure, as well as across demographic subgroups such as older patients and those with higher cardiovascular risk profiles. Aprocitentan has also shown a manageable safety profile, with mild and transient edema as the most commonly observed treatment-related effect and no significant drug–drug interactions – an important consideration in patients with complex regimens. Importantly, no signal for hyperkalemia or hyponatremia was observed, supporting its use in patients with resistant and difficult-to-control hypertension, including those with chronic kidney disease, even with an eGFR (estimated glomerular filtration rate) as low as 15ml/min/1.73m2, diabetes, or heart failure, without additional electrolyte monitoring burden. About aprocitentanAprocitentan is approved as TRYVIO® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. TRYVIO is now included in the American College of Cardiology’s (ACC) and the American Heart Association’s (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union, the UK, and Switzerland, and a marketing authorization application is under review in Canada. Notes to the editor About Prof. Markus Schlaich, MDMarkus Schlaich is a nephrologist and a European Society of Hypertension (ESH) accredited hypertension specialist. He is a Fellow of the American Heart Association (FAHA), the European Society of Cardiology (FESC), and the International Society of Hypertension (ISHF). He served as an Executive Committee of the ISH from 2018-2020 and is currently on the Management Board of the global ISH May Measurement Month campaign. Markus is President of Hypertension Australia and a Trustee of the Foundation for High Blood Pressure Research. Markus has a strong background in clinical research with a focus on the pathophysiology of hypertension, involvement of the kidneys, and hypertension mediated organ damage. He has a specific interest in treatment modalities targeting the sympathetic nervous system and other relevant pathways such as the endothelin system to improve BP control and thereby outcomes for patients with difficult-to-control hypertension. For his work he received the Björn Folkow Award from the European Society of Hypertension (ESH) and the Arthur C. Corcoran Award from the AHA Hypertension Council, both in 2021. He has authored more than 450 articles in peer-reviewed journals and serves on the Editorial Board of Hypertension and Journal of Hypertension. Prof. Schlaich serves as a consultant to Idorsia. Key literature Danaietash P et al. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertension 2022 Jul;24(7):804-813.Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937.Rossignol P, et al. Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension. Online ahead of print, December 2025, doi.org/10.1161/HYPERTENSIONAHA.125.25563Iglarz M, et al. At the heart of tissue: endothelin system and end-organ damage. Clin Sci 2010; 119:453-63.Clozel M. Aprocitentan and the endothelin system in resistant hypertension. Can J Physiol Pharmacol 2022; 100:573-83. About IdorsiaThe purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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Mineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)

– Post hoc analysis from pivotal Launch-HTN trial shows statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease – – In participants with chronic kidney disease and baseline albuminuria, lorundrostat significantly reduced urine albumin-to-creatinine ratio – – Lorundrostat demonstrated a favorable safety profile in participants with and without chronic kidney disease over 12 weeks – RADNOR, Pa., May 30, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a 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, today presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland. “Despite the availability of current therapies, up to 75 percent of patients with chronic kidney disease still have uncontrolled or resistant blood pressure, contributing to a high risk of cardiovascular events and kidney disease progression,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “These results, together with our Explore-CKD trial findings, demonstrate lorundrostat’s potential to address the compounded burden of hypertension and CKD, underscoring its promise as an important potential treatment option for this difficult-to-treat population with high unmet need.” The analysis evaluated the efficacy and safety of once-daily lorundrostat 50 mg by CKD status among 800 participants with uncontrolled or resistant hypertension enrolled in the randomized, double-blind, placebo-controlled Phase 3 Launch-HTN trial. Among participants with CKD (n=192), 71% were receiving three or more anti-hypertensive medications at baseline, compared with 56% of those without CKD. In addition, 31% of participants with CKD had systolic blood pressure (SBP) ≥160 mmHg at baseline, versus 17% of participants without CKD. Lorundrostat demonstrated significant reductions in SBP that were comparable between CKD and non-CKD participants. At week 12, placebo-adjusted SBP reductions were 9.6 mmHg in participants with CKD (p=0.0022) and 12.2 mmHg in those without CKD (p

HeartFocus Launches HeartFocus Link, Bringing AI-Guided Cardiac Ultrasound Education and Guidance to Any Cart-Based System

BORDEAUX, France–(BUSINESS WIRE)–HeartFocus, AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, has announced its expansion to any cart-based system with the launch of HeartFocus Link. Available now for medical schools, residency, and ultrasound training programs, HeartFocus Link addresses one of the most persistent barriers in cardiac ultrasound education and adoption: the challenge of helping healthcare professionals build confidence and competency using the

CorWave Achieves Major Regulatory Milestone with ISO 13485 Certification Across its Entire Operations

CLICHY, France–(BUSINESS WIRE)–CorWave, a clinical-stage medical company pioneering innovative cardiac assist devices, announces that its Quality Management System has been certified by an independent notified body in accordance with the international ISO 13485 standard. The certification covers the design, development, manufacturing, distribution, and servicing of implantable Left Ventricular Assist Devices (LVADs). This certification marks a foundational regulatory milestone on the path to

FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Assessment Beyond the Hospital

SANTA CLARA, Calif.–(BUSINESS WIRE)–Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheter

Groundbreaking therapy for advanced heart failure: Outcomes of the BIOVAT-HF clinical trial published in NEJM

Repairon Announces Publication of Clinical Trial Results for Engineered Human Heart Muscle Tissue in the New England Journal of MedicineGÖTTINGEN, Germany and PROVIDENCE, R.I., May 28, 2026 (GLOBE NEWSWIRE) — Repairon, a biotechnology company developing regenerative cardiac therapies, today announced that clinical results evaluating its engineered human heart muscle tissue for patients with advanced heart failure have been published in the New England Journal of Medicine (NEJM). The publication concludes that restoration of heart muscle function in patients with advanced heart failure is achievable, resulting in improved health and quality of life. Publication details: Zimmermann WH, Ensminger S, Kutschka I, et al. Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure. N Engl J Med. May 28;394(20):1991-2001 DOI: 10.1056/NEJMoa2513525 The data were generated in the BioVAT-HF clinical trial (BiologicalVentricularAssistTissue in TerminalHeartFailure). Designed to assess safety and preliminary efficacy, this Phase 1-2 study involved implanting fully functional heart muscle patches engineered from human induced pluripotent stem cell-derived terminally differentiated heart muscle cells onto the weakened left ventricular muscle of patients with advanced heart failure with reduced ejection fraction (HFrEF), alongside guideline-directed medical therapy. The trial began with a dose-escalation phase to establish the safe maximum dose, followed by treatment at that dose to further evaluate safety and efficacy. Of the 20 patients enrolled, 16 received the safe maximum dose. At the time of reporting, the last enrolled patient had completed 3 months of follow-up, and follow-up across these patients ranged from 6 to 52 months. Key safety findings from the NEJM Publication indicate that 3 patients died during the trial from causes that the Data Safety Monitoring Board graded as unrelated to the BioVAT. Severe adverse events were mostly related to underlying heart and concurrent diseases as well as to immunosuppression requiring adaptation of the immunosuppression regimen. 3 patients experienced episodes of ventricular tachycardia which were found to be unrelated to the BioVAT transplant. No patients had ventricular fibrillation. Among the 16 safe maximal dose patients, there were heart failure hospitalizations for 2 patients. The efficacy findings from the NEJM Publication indicate that for those patients who received the safe maximal dose, from baseline: Target heart wall thickness increased 4.5 mm at 3 months and 2.9 mm at 12 months follow-up.Left ventricular ejection fraction increased 3.9% at 3 months and 6.9% at the latest timepoint.Quality of Life as measured by KCCQ-OSS increased 6.7 points at 3 months and 15 points at 12 months follow-up. The study outcomes support preclinical findings that engineered heart muscle can integrate with damaged myocardium, form a vascularized layer, and contract in synchrony with native tissue. This was further confirmed by analysis of an explanted heart from a patient in the dose-finding cohort who later underwent cardiac transplantation, providing clear evidence of human heart remuscularization and associated increases in wall thickness, ejection fraction, and quality of life. The authors concluded that further clinical investigations with longer follow-up times are warranted. Wolfram-Hubertus Zimmermann. MD, professor and director of the Institute of Pharmacology and Toxicology at the University Medical Center Goettingen, Germany, and principal author of the NEJM Publication, remarked that “heart failure therapies available today can often slow the progression of the disease, but they cannot replace destroyed heart muscle. Our goal, therefore, is to generate new, functional heart muscle tissue and thereby provide targeted support to the weakened heart.” Lothar Germeroth, Ph.D., Repairon’s CEO, stated: “We are highly encouraged by these Phase II results, which we believe validate the therapeutic potential of our regenerative cardiac patch platform. Heart failure remains one of the leading causes of morbidity and mortality worldwide, and we believe these findings may open a new chapter in myocardial regeneration and restorative cardiovascular medicine.” High medical need in advanced heart failure: Approximately 5% of the global population suffers from chronic heart failure of any severity, and it remains one of the most common causes of death. In the US, heart failure represents the most common cause of hospitalization and mortality in the senior population, and over 6 million people are affected. As heart failure progresses to advanced stages, patients experience weakness with discomfort during all physical activities and at rest, sometimes even requiring constant bed rest. For these severely ill patients, the only treatment options currently available are mechanical pump devices or heart transplantation. About Repairon: Repairon GmbH is a German biotech company based in Göttingen, Germany, focused on developing regenerative cell therapies for cardiac medicine. The company was founded in 2014 based on research by Wolfram-Hubertus Zimmermann, MD and his team at the University Medical Center Goettingen, who have developed several tissue engineering technologies with proven applicability for organ repair and drug development. Repairon’s lead therapeutic candidate, the human engineered heart muscle patch, is currently being evaluated in the BioVAT-HF Phase 2 clinical trial as a biological ventricular assist tissue (BioVAT) for end-stage heart failure. Company contact:Dr. Lothar GermerothRepairon GmbH37079 Göttingen – GermanyEmail: l.germeroth@repairon.comUS contact:Frank AhmannRepairon USAProvidence, RI Email: f.ahmann@repairon.com

Cardiosense Receives FDA De Novo Classification for Novel Cardiac Technology Designed to Improve Care for Patients with Heart Failure

CHICAGO–(BUSINESS WIRE)–Cardiosense, a healthcare technology company focused on heart failure care, today announced that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software™, a first-in-class technology to estimate a key indicator of heart health noninvasively. With this authorization, Cardiosense has a clear path forward in supporting clinicians who manage heart failure by providing critical data to improve therapy and avoid prolong

Editas Medicine Presents EDIT-401 Preclinical Data Demonstrating Robust Reductions in LDL-C, Lp(a), and ApoB in Non-Human Primates at the 94th European Atherosclerosis Society Congress

Single dose of EDIT-401 achieved ~90% or greater mean reductions in LDL-C, Lp(a), and ApoB in non-human primates Data reinforce differentiated LDLR upregulation approach with rapid, dose-dependent effects on multiple atherogenic lipoproteins Company on track to submit CTN by mid-2026 for EDIT-401 and achieve early in vivo human proof-of-concept data by the end of 2026 CAMBRIDGE, Mass., May 26, 2026 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company focused on developing transformative medicines for serious diseases, presented new preclinical data for EDIT-401, its lead in vivo development candidate, in an oral presentation at the 94th European Atherosclerosis Society (EAS) Congress in Athens, Greece on May 25, 2026. In the data presented, EDIT-401 achieved robust reductions in LDL-cholesterol (LDL-C), lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB) in non-human primates (NHPs), supporting its potential as a best-in-class medicine for hyperlipidemia. Key EDIT-401 preclinical data in NHPs presented include: A single dose of EDIT-401 achieved ≥90% mean reduction in LDL-C, with rapid and dose-dependent effect.EDIT-401 achieved rapid, dose dependent ~90% mean reduction in Lp(a), an independent risk factor for atherosclerotic cardiovascular disease (ASCVD).EDIT-401 achieved rapid, dose-dependent ~90% mean reduction in ApoB, a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD.Reductions in LDL-C, Lp(a), and ApoB were highly correlated, supporting a unified mechanism facilitated by LDLR upregulation. “The consistent reductions of ~≥90 percent with EDIT-401 in LDL-C, Lp(a), and ApoB observed in these preclinical studies highlight the transformative potential of our LDLR upregulation approach to address multiple drivers of cardiovascular risk, including residual risk beyond LDL-C alone,” said Linda C. Burkly, Ph.D., Executive Vice President and Chief Scientific Officer, Editas Medicine. “These robust and consistent reductions across multiple atherogenic lipoproteins with a single dose further support EDIT-401 as a potentially best-in-class in vivo gene editing medicine for people living with hyperlipidemia.” The abstract can be accessed on the EAS website, and the presentation is available on the Editas Medicine website. Editas continues to advance preclinical studies for EDIT-401, including an ongoing Good Laboratory Practice (GLP) toxicology study in NHPs. Interim results from this study demonstrated EDIT-401 was well-tolerated with no adverse clinical observations, no notable treatment-related liver enzyme elevations, and no liver histopathology findings in non-GLP toxicology at the therapeutically relevant dose of 1.5 mg/kg. The Company also received positive pre-IND feedback from the U.S. Food and Drug Administration (FDA) on its nonclinical package, CMC plans, and study design to support an Investigational New Drug Application (IND). The Company plans to submit a Clinical Trial Notification (CTN) in Australia to the Therapeutic Goods Administration (TGA) by mid-2026 to initiate a first-in-human clinical trial of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (HeFH) later this year, and is on track to have early in vivo human proof-of-concept data for EDIT-401 by the end of 2026. About Editas Medicine As a pioneering gene editing company, Editas Medicine is focused on translating the power and potential of CRISPR genome editing systems into a robust pipeline of transformative in vivo medicines for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize durable, precision in vivo gene editing medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.   Forward-Looking StatementsThis press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Company’s preclinical studies and its research and development programs, including initiating a first-in-human study for EDIT-401 in 2026 and achievement of early in vivo human proof-of-concept data for EDIT-401 by the end of 2026; the potential of, and expectations for, EDIT-401; and the timing or likelihood of regulatory filings and approvals, including submitting a CTN in Australia by mid-2026 for EDIT-401. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials; availability and timing of results from preclinical studies and clinical trials; uncertainties relating to planned regulatory submissions to initiate clinical trials, including that results of preclinical studies will warrant such submissions or that regulatory agencies may require additional preclinical studies, that regulatory submissions shall occur on the expected timelines and that regulatory authorities will provide clearance for trials to be initiated; that the results and outcome of preclinical studies may not be predictive of the results of clinical trials; and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements. CONTACT: Investor and Media Contacts: 
ir@editasmed.com
media@editasmed.com   

Novo Nordisk global observational study reveals 2 in 5 people with cardiovascular disease have cardiovascular inflammation, increasing their risk of heart attack and stroke

The Novo Nordisk study POSEIDON – including 18,904 patients across 18 countries – showed that cardiovascular (CV) inflammation remains highly prevalent among people with cardiovascular disease (CVD), despite current standard of care treatment1,2In fact, two in five people with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD), or heart failure, have CV inflammation1,2This matters because CV inflammation is an independent risk factor for CV events, such as heart attack and stroke, in people living with CVD, and it shows a significant gap in CV care globally3 Bagsværd, Denmark, 26 May 2026 – Novo Nordisk today presented new results from the landmark POSEIDON real-world evidence study at the 94th European Atherosclerosis Society (EAS) Congress in Athens, Greece. The study showed that CV inflammation remains highly prevalent among people with CVD despite current standard-of-care treatment. The study found that 2 in 5 people with ASCVD and CKD had CV inflammation, which is associated with an increased risk of major CV events2,4. A second POSEIDON analysis recently published in the European Journal of Heart Failure showed that two in five people with heart failure also have CV inflammation1. In POSEIDON, CV inflammation was measured and defined by high-sensitivity C-reactive protein (hsCRP) levels ≥2 mg/L1. hsCRP is the most commonly used and widely available blood test for measuring CV inflammation4-6. These findings underscore a significant gap in current CV care. Even when people receive guideline-recommended treatments to control, e.g., cholesterol, blood pressure and blood sugar, inflammation-driven CV risk persists3,7. The POSEIDON study represents one of the largest contemporary global assessments of CV inflammation prevalence in this high-risk population1,2. “The POSEIDON study provides critical evidence that cardiovascular inflammation represents a significant source of persistent risk in people living with atherosclerotic cardiovascular disease and chronic kidney disease or heart failure, despite receiving standard of care treatment today,” said Filip Knop, senior vice president and chief medical officer at Novo Nordisk. “Understanding the scope of cardiovascular inflammatory risk is essential, as we continue our innovation-driven research to develop a first-in-class therapy with the potential to address this critical unmet need.” POSEIDON enrolled 18,904 patients across 18 countries spanning Europe, North America, South America and Asia-Pacific between 2023 and 20251,2. Within the study, 13,475 patients had ASCVD, of whom 5,757 (42.7%) had CKD, while 11,809 patients had heart failure spanning across all types of heart failure (preserved, mildly reduced or reduced)1,2. Cardiovascular inflammation plays a central role in the development and progression of ASCVD8,9. Multiple studies have shown that people with CV inflammation face an increased risk of major adverse cardiovascular events, including heart attack, stroke and CV death3-5. Inflammation also contributes to CKD progression, and CKD itself may promote inflammation, creating a cycle that amplifies CV risk9. It also plays a key role in heart failure, and it is common across all types of heart failure, particularly in people with obesity, kidney disease and other metabolic conditions1,10. “POSEIDON makes clear that inflammation is not a peripheral concern – it is a shared driver of risk affecting millions of patients worldwide with cardiovascular disease who remain vulnerable despite our best current therapies,” said Professor Carolyn S.P. Lam, Senior Consultant, Department of Cardiology, National Heart Centre Singapore; and Professor, Cardiovascular & Metabolic Disorders Signature Research Programme, Duke-NUS Medical School. “What is striking is the consistency of inflammatory signals across such diverse patient populations. That consistency points to a practical way forward – identifying patients most likely to benefit from therapies that directly target inflammation. This reframes how we should think about residual cardiovascular risk, and it underscores the promise of emerging anti-inflammatory therapies to address a real unmet need.” The growing recognition of the role of inflammation in cardiovascular disease is reflected in recent guidelines from the European Society of Cardiology (ESC), the American Heart Association (AHA), and the American College of Cardiology (ACC), which include elevated hsCRP as a risk-modifying biomarker to guide more intensive preventive initiatives11,12. About POSEIDONPOSEIDON is a large, multinational, cross-sectional observational real-world evidence study designed to evaluate the prevalence and characteristics of high inflammatory risk (defined as hsCRP ≥2 mg/L) in patients with ASCVD, with and without CKD and/or heart failure. The study enrolled 18,904 patients across 18 countries between 2023 and 2025. Patients with recent infections, hospitalisations or unplanned medical visits were excluded to ensure that inflammatory markers reflected CV inflammation rather than acute conditions1,2. About cardiovascular inflammationCardiovascular inflammation is increasingly recognised as a key driver of ASCVD and a major contributor to persistent cardiovascular risk in people receiving standard preventive therapies. It also plays a key role in heart failure, and it is common across all types of heart failure (preserved, mildly reduced or reduced), particularly in people with obesity, kidney disease and other metabolic conditions. hsCRP is the most widely available blood test and validated biomarker of CV inflammation. Levels of CV inflammation ≥2 mg/L are associated with increased risk of major adverse CV events, including heart attack, stroke and CV death4-6. Despite standard of care management of traditional risk factors such as cholesterol, blood pressure and blood sugar, many people with ASCVD continue to face elevated CV risk driven in part by persistent inflammation2,3,7. The same is true for people with any type of heart failure, where CV inflammation is associated with more severe symptoms and an increase in the overall CV risk1. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 67,900 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.   Contacts for further information Novo Nordisk Media: Ambre James-Brown+45 3079 9289globalmedia@novonordisk.com Liz Skrbkova (US)+1 609 917 0632usmediarelations@novonordisk.comNovo Nordisk Investors: Michael Novod+45 3075 6050nvno@novonordisk.comJacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656 azey@novonordisk.comMax Ung+45 3077 6414mxun@novonordisk.comChristoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.com Alex Bruce+45 3444 2613axeu@novonordisk.com Mads Berner Bruun+45 3075 2936mbbz@novonordisk.comFrederik Taylor Pitter (US)+1 609 613 0568fptr@novonordisk.com _______________________References1.      Lam CSP, Contreras J, Darwesh R, et al. Prevalence and Predictors of High Inflammatory Risk in Heart Failure Subtypes: Findings From the Global POSEIDON Study. Eur J Heart Fail. 2026.2.      Navar A, Bai L, Højen J, et al. Global Prevalence of Elevated High-Sensitivity C-Reactive Protein in Patients with Atherosclerotic Cardiovascular Disease, With and Without Chronic Kidney Disease: Findings From the POSEIDON Study. Late breaker oral presentation at the European Atherosclerosis Society 2026; May 24-27 2026; Athens, Greece.3.      Ridker PM. Clinician’s Guide to Reducing Inflammation to Reduce Atherothrombotic Risk: JACC Review Topic of the Week. J Am Coll Cardiol. 2018;72(25):3320-3331.4.      Ridker PM, Bhatt DL, Pradhan AD, et al. Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials. Lancet. 2023;401(10384):1293-1301.5.      Ridker PM, Lei L, Louie MJ, et al. Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13 970 Contemporary High-Risk Patients With Statin Intolerance. Circulation. 2024;149(1):28-35.6.      FDA. Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/review-criteria-assessment-c-reactive-protein-crp-high-sensitivity-c-reactive-protein-hscrp-and Last accessed: May 2026.7.      Peikert A, Kaier K, Merz J, et al. Residual inflammatory risk in coronary heart disease: incidence of elevated high-sensitive CRP in a real-world cohort. Clin Res Cardiol. 2020;109(3):315-323.8.      Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. New England Journal of Medicine. 2005;3521685–1695.9.      Lawler PR, Bhatt DL, Godoy LC, et al. Targeting cardiovascular inflammation: next steps in clinical translation. European Heart Journal. 2021;42113–131.10.      Mesquita T, Lin YN, Ibrahim A. Chronic low-grade inflammation in heart failure with preserved ejection fraction. Aging Cell. 2021;20(9):e13453.11.      Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;74(10):e177-e232.12.      Visseren FLJ, Mach F, Smulders YM, et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). European Heart Journal. 2021;42(34):3227-3337.
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