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Ad hoc announcement pursuant to Art. 53 LR Idorsia appoints Roland Wandeler as CEO – effective October 1, 2026 – an experienced biopharmaceutical executive combining scientific expertise with business acumen to translate innovation into performance and lead Idorsia’s next phase of growthAllschwil, Switzerland – July 1, 2026Idorsia Ltd (SIX: IDIA) today announced the appointment of Roland Wandeler, PhD, as Chief Executive Officer (CEO), effective October 1, 2026. The appointment comes at a pivotal stage for Idorsia, as the company continues to execute its strategy to accelerate growth and unlock the full value of its innovative portfolio. Roland Wandeler will succeed Jean-Paul Clozel, MD, who has been serving as ad-interim CEO since March 2026 and will continue in his role as Chairman of the Board of Directors. Jean-Paul Clozel will remain CEO until October 1, 2026, ensuring full continuity in the execution of Idorsia’s strategic priorities. A leader with broad global experience across pharma and biotechRoland Wandeler, PhD, is a global biopharmaceutical executive with more than 25 years of leadership experience across the United States, Europe, and international markets. He currently serves as President, Biopharma at Grifols, where he leads a multi-billion-dollar global business. Previously, he held senior leadership roles at Amgen, including leading a major US business unit, and served as Chief Operating Officer of MorphoSys. He holds a PhD in technical sciences from ETH Zurich. Gabriel Baertschi, Chair of Idorsia’s Nominating, Governance & Compensation Committee, commented:“Following a comprehensive and rigorous global search, we are very pleased to appoint Roland Wandeler as CEO of Idorsia. He brings extensive experience across both Europe and the United States, spanning large pharmaceutical organizations and more entrepreneurial biotech environments. His scientific background, combined with a strong track record in building and leading teams and delivering commercial success, positions him strongly to take the reins. Roland understands both the dynamics of large markets and the realities of local execution, making him ideally suited to lead Idorsia through its next phase of growth.” Selecting the right leaderThe Board placed particular emphasis on identifying a leader with a long-term focus, a strong alignment with the company’s vision, and who can nurture a culture of innovation, ambition, and a pragmatic, hands-on approach. Jean-Paul Clozel, MD, Chairman of the Board and ad-interim CEO, commented:“Roland and the Board are fully aligned on Idorsia’s vision to create long-term value through innovative medicines that address significant medical needs. Our priority is to focus the organization on the activities that drive growth and maximize the impact of our portfolio. Idorsia has a unique culture rooted in science, combined with ambition and entrepreneurial spirit, and I am confident that Roland will build on this foundation and successfully advance the company.” A compelling portfolio and strong momentumRoland Wandeler, PhD, commented:“I am honored to join Idorsia and to work alongside a team that has built such a remarkable culture of scientific innovation and commitment to patients. What attracted me most is the combination of world-class science, meaningful therapies, and talented people united by a clear purpose: improving the lives of patients.” “I have been particularly impressed by the global potential of QUVIVIQ, a best-in-class therapy in insomnia, that is already helping patients around the world today, with further opportunities following the recent positive pediatric data. At the same time, innovative treatments such as TRYVIO/JERAYGO, targeting a novel pathway in hypertension; lucerastat for Fabry disease; and a compound with the potential to remyelinate in multiple sclerosis, underscore the strength of Idorsia’s late-stage and emerging pipeline and its ability to redefine standards of care.” “This combination of outstanding science and a company that has successfully navigated a financial turnaround creates a compelling opportunity. I am excited to work with the team to accelerate growth, and deliver lasting impact for patients, while creating long-term value for all our stakeholders.” Broadening commercial and partnering expertise within the executive leadership team Benjamin Limal, President Europe & International Markets, will join the Idorsia Executive Committee following strong performance across the region, where the launch and expansion of QUVIVIQ have driven accelerating uptake across key markets. Dominique Le Terrier, General Manager of France & Benelux, will assume the newly created role of Head of Global Commercial Strategy & New Product Planning and also join the Executive Committee, where he will lead global commercialization strategies for pipeline and launch assets from Phase 2 onwards, supporting future launches and portfolio value creation. Idorsia has also appointed Begoña Carreño-Gómez as Chief Business Development Officer and member of the Idorsia Executive Committee, effective November 1, 2026. She brings extensive experience in business development and licensing across both large pharmaceutical organizations and entrepreneurial biotech environments. With a strong scientific background and a proven track record in structuring partnerships and complex transactions, she will play a key role in maximizing the value of Idorsia’s portfolio by advancing strategic partnerships across assets at all stages of development, from research and platform technologies to clinical-stage and commercial products. Notes to the editor About Roland WandelerRoland Wandeler, PhD, is a global biopharmaceutical executive with more than 25 years of leadership experience across the United States, Europe, and international markets. He has a proven track record of driving commercial performance, leading organizational transformation, and delivering sustainable growth in complex and evolving healthcare environments. He currently serves as President, Biopharma at Grifols, where he leads the company’s core division, representing the majority of group revenues and overseeing a global organization with business in over 100 markets. In this role, he has strengthened financial discipline, accelerated profitable growth, and contributed to shaping enterprise strategy while engaging actively with equity and credit investors. Prior to joining Grifols, Roland Wandeler held senior leadership roles at Amgen, including Corporate Vice President and General Manager of one of the company’s largest US business units. There, he led a successful commercial turnaround, drove strong revenue and profitability growth, and implemented pricing and market access strategies to expand patient access in the United States. He also led Amgen’s operations in Germany and Iberia as General Manager, where he restored growth and improved organizational performance. He previously served as Chief Operating Officer of MorphoSys, where he played an important role in transforming the company from a research-focused organization into an integrated, US-oriented biotech with global commercial capabilities. Earlier in his career, Roland Wandeler was a consultant at The Boston Consulting Group, focusing on healthcare strategy and transformation for leading pharmaceutical and biotechnology companies in Europe and the United States. Roland Wandeler holds a PhD in technical sciences (Dr. sc. techn.) from ETH Zurich, where he graduated with distinction and received the ETH Medal for his doctoral work. He also holds a Master’s degree in Chemical Engineering (Dipl. Chem.-Ing ETH) from ETH Zurich. He is a Swiss national with international experience and has lived and worked extensively in different parts of both Europe and the United States. He is fluent in English and German and proficient in Spanish. About Begoña Carreño-GómezBegoña Carreño-Gómez, PhD, is a biopharmaceutical business development executive with more than 20 years of experience spanning research, strategy, and deal-making across global pharmaceutical and biotechnology companies. She most recently served as Chief Business Development Officer at Aspeya, where she built and led the company’s business development and licensing function. In this role, she executed more than 15 transactions across licensing, co-development, divestments, and strategic collaborations, creating significant value from a diversified portfolio of assets. Prior to Aspeya, Begoña was Global Business Development & Licensing Head (BD&L) in the Ophthalmology franchise at Novartis Pharma, AG, based in Basel. She has led BD&L efforts at Novartis across five different therapeutic franchises (respiratory, cardiovascular, metabolism, arthritis, bone and musculoskeletal diseases), as well as a proven track record in licensing deals and M&A. Before joining Novartis, she was the Head of External Pharmaceutical projects at Almirall (Barcelona, Spain). Dr. Carreño holds a PhD in Drug Delivery from the London School of Pharmacy, a 3-year Postdoctoral Research fellow at the Centre for Polymer Therapeutics (London School of Pharmacy, UK) and a BSc in Biochemistry from Keele University (UK). 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. Idorsia has transferred its rights for aprocitentan, cenerimod and selatogrel to Idorsia Investments SARL to allow the repayment of notes issued in connection with the repurchase offer completed in August 2025. More details on the transfer can be found in the press release issued on May 21, 2025, and on the exchange offer in the press release issued on August 27, 2025.
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NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a modular review of its BLA for rexlemestrocel-L in prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD). Rexlemestrocel-L has received Orphan Drug Designation for prevention of life-threatening major mucosal bleeding events and has Regenerative Medicine Advanced Therapy (RMAT) designation for this patient population, providing eligibility for rolling and priority reviews of the BLA. The new FDA leadership this past week provided additional guidance to how it approaches regulatory flexibility for products which address orphan rare diseases with high mortality and irreversible morbidity. The new draft guidance to industry titled ‘Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products’1 highlights FDA’s flexible approach to substantial evidence of effectiveness. This follows the May guidance from FDA titled ‘Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application.’2 Mesoblast Chief Executive Dr. Silviu Itescu said: “We look forward to working closely with FDA to make rexlemestrocel-L available for the end-stage heart failure patients on mechanical devices who are at high risk of developing life-threatening gastrointestinal bleeding caused by progressive right heart failure.” About Rexlemestrocel-L in Heart DiseaseRexlemestrocel-L is an allogeneic preparation of immunoselected and culture-expanded mesenchymal precursor cells (MPC) and is being developed as an immunomodulatory therapy to address the high degree of inflammation in the heart and in the circulation that is present across the spectrum of heart failure and reduced ejection fraction (HFrEF) patients, from New York Heart Association (NYHA) class II through end-stage CHF, in order to reduce the high rate of major cardiac events and complications. This investigational therapy has been trialled in two large placebo-controlled randomized studies in patients with CHF, a 565-patient trial in NYHA class II/III HFrEF patients and a 159-patient trial in end-stage HFrEF patients implanted with a left ventricular assist device (LVAD). Rexlemestrocel-L has US Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for patients with end-stage HFrEF implanted with an LVAD. About Chronic Heart Failure Chronic heart failure (CHF) is characterized by poor heart function resulting in insufficient blood flow to the body’s vital organs and extremities. This condition affects approximately 6.5 million people in the United States and 26 million people globally with increasing prevalence and incidence. CHF patients are commonly classified according to the New York Heart Association (NYHA) categories based on the patient’s physical limitations. Class I (mild) patients have no limitations while Class IV patients (severe/end stage) experience symptoms even at rest. The mortality rate approaches 50% at 5 years as patients progress beyond NYHA early class II disease in parallel with increasing inflammation in the heart and in the circulation.3,4 Despite recent approvals of new therapies for HFrEF, NYHA class II/III HFrEF patients with inflammation remain at high risk for cardiac death, heart attacks and strokes. Every year in the United States over 100,000 patients progress to end-stage HFrEF, with a one-year mortality as high as 50%.5 In these patients, more than 2,500 life prolonging LVADs are implanted in the US annually, of whom approximately 80% undergo the procedure as destination or permanent therapy.6 Most patients receiving LVADs as destination therapy have an ischemic HFrEF etiology. Compared to patients with non-ischemic HFrEF, patients with ischemic HFrEF have a 76% lower likelihood of LV functional recovery following LVAD implantation,7 and increased mortality over the initial 1-2 years.8 Resistance to functional recovery in ischemic HFrEF patients is thought to be due to excessive inflammation and microvascular insufficiency in the ischemic myocardium.9 About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast Footnotes / References United States Food & Drug Administration. Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry. Draft Guidance. June 2026United States Food & Drug Administration. Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application Guidance for Industry. May 2026AHA’s 2017 Heart Disease and Stroke StatisticsPonikowski P., et al. Heart Failure: Preventing disease and death worldwide. European Society of Cardiology. 2014; 1: 4-25Gustafsson F, Rogers JG. Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes. European Journal of Heart Failure 2017;19:595-602.Yuzefpolskaya M et al. Ann Thorac Surg 2023; 115:311-28Wever-Pinzon, Selzman CH, Stoddard G, et al. Impact of Ischemic HF etiology on Cardiac Recovery During Mechanical Unloading. J Am Coll Cardiol 2016;68:1741-1752. doi: 10.1016/j.jacc.2016.07.756.Mehra MR, Goldstein DJ, Cleveland JC, et. al. Five-year outcomes in patient with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM 3 randomized trial. JAMA 2022; doi:10.1001/jama.2022.161972.Symons JD, Deeter L, Deeter N, et al. Effect of continuous-flow left ventricular assist device support on coronary artery endothelial function in ischemic and nonischemic cardiomyopathy. Cir Heart Fail 2019; 12:e006085. DOI: 10.1161/CIRCHEARTFAILURE.119.006085. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGvHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Media – AustraliaRubensteinBlueDot MediaCaroline NelsonSteve DabkowskiT: +1 703 489 3037T: +61 419 880 486E: cnelson@rubenstein.comE: steve@bluedot.net.au
GREENBRAE, Calif.–(BUSINESS WIRE)– #Marin–MarinHealth today announced the official launch of the Haynes Heart & Vascular Institute, recognizing the transformational generosity and enduring legacy of the late Bill Haynes and Reta Haynes, whose vision and philanthropy helped shape one of the North Bay’s premier cardiovascular programs. The naming of the Institute celebrates the Haynes family’s longstanding commitment to advancing heart care and reflects MarinHealth’s continued investment in innovat
$3 million upfront with up to approximately $5.8 million of potential additional gross proceeds upon the exercise in full of warrants Net proceeds anticipated to extend cash runway into first quarter of 2027; if warrants are exercised in full for cash, it is anticipated that the cash runway would extend into second half of 2027 to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT PONTE VEDRA, Fla., June 30, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) (the “Company”), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 960,000 shares of its common stock (or pre-funded warrants in lieu thereof), series C-1 warrants to purchase up to an aggregate of 960,000 shares of common stock and series C-2 warrants to purchase up to an aggregate of 960,000 shares of common stock, at a combined purchase price of $3.125 per share (or pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The series C-1 warrants will have an exercise price of $3.00 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock issuable upon exercise of the series C-1 warrants (the “Stockholder Approval Date”) and will expire five years after the later of (i) the Stockholder Approval Date and (ii) the effective date of a resale registration statement registering for resale all of the shares of common stock underlying the series C-1 warrants. The series C-2 warrants will have an exercise price of $3.00 per share, will be exercisable immediately upon issuance, and will expire twenty-four months after the effective date of a resale registration statement registering for resale all of the shares of common stock and the shares of common stock underlying the series C-2 warrants. The aggregate gross proceeds to the Company from the offering are expected to be $3 million, before deducting placement agent fees and other offering expenses. The potential additional gross proceeds to the Company from the series C-1 warrants and the series C-2 warrants, if fully exercised on a cash basis, will be approximately $5.8 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The offering is expected to close on or about July 1, 2026, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital purposes. The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications. The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially, those with Kawasaki disease (KD), an acute self-limited febrile illness that primarily affects children
Clinically Validated, Increasingly Prescribed, Widely Reimbursed, and Affordable, VASCEPA Expected to Benefit from Increased Attention to Patients with Severely Elevated TriglyceridesDUBLIN, Ireland and BRIDGEWATER, N.J., June 30, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease worldwide, applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL.i These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis. “The renewed attention triglycerides generated by the introduction of innovative therapies is welcome, as they help to drive patient–physician conversations and bring critical awareness to the dangers of very high triglyceride levels,” said Aaron Berg, CEO of Amarin. “We recognize the important therapeutic advancement that APOC3 therapies represent and are optimistic about their potential benefit in patients at high risk of acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. We remain mindful that issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. Therefore, we are confident that VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia.” Mr. Berg noted the following: Robust Reductions in sHTG Without LDL-C Increases: VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks.ii,iii These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG.iv,v,vi Lower Cost, Proven Efficacy, and Broad Access: There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements.vii Elevated Triglyceride Patients are at Increased Risk for Cardiovascular Disease: VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors.viii Global Guideline Support Recently Reaffirmed: 70+ leading medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology / American Heart Association / Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides.i Mr. Berg concluded, “We fully appreciate the potential benefits of recently introduced therapies for the segment of sHTG patients who are at high risk of acute pancreatitis. However, for the majority of the sHTG patient population, and for the broader global population of patients with elevated triglycerides at risk for cardiovascular events, significant clinical and economic value will be derived from prioritizing treatments such as VASCEPA that are proven, safe, commonly prescribed, affordable, and widely reimbursed.” About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez The Equity Group on Behalf of Amarin devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of printii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015.iii Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl). Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdfiv https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21cfa4ce-0b05-47ed-b268-339eb1b83b75 v https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf vi Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761. vii Annual wholesale acquisition cost: published WAC pricing / data on file. [Medi-Span® Price Rx Pro®”]viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792
KIRKLAND, Wash., June 30, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, is scheduled to report fourth quarter fiscal 2026 financial results after the market closes on Tuesday, July 14. Management will host a conference call at 4:30 p.m. Eastern Time to discuss financial results. A live and archived webcast of the conference call will be available in the “Events” section of the investor relations website. About KestraKestra Medical Technologies, Ltd. is a leading wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
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