Iodine (124I) evuzamitide

Bayer has reported that iodine 124 evuzamitide met both primary endpoints in the Phase III REVEAL study, demonstrating sufficient sensitivity and specificity for cardiac amyloidosis PET imaging by visual scan interpretation — results that could support the first FDA-approved diagnostic agent specifically labeled for the condition. The long-standing diagnostic need Cardiac amyloidosis is caused by the accumulation of misfolded proteins in heart tissue, progressively impairing cardiac function and leading to heart failure, frequent hospitalization, and early mortality. Despite growing clinical awareness, the disease carries a diagnostic delay of roughly two to four years from symptom onset, with patients typically consulting multiple specialists and undergoing several imaging procedures before receiving an accurate diagnosis. The core problem is structural: no single non-invasive test currently holds FDA approval for reliably detecting cardiac amyloidosis. The dominant clinical tool — technetium-99m pyrophosphate (99mTc-PYP) scintigraphy — is used entirely off-label for this purpose. Its clinical utility is also constrained by a fundamental limitation: it detects transthyretin amyloidosis (ATTR) selectively but performs poorly in light-chain amyloidosis (AL), the second major subtype. Patients with AL cardiac involvement must often proceed to endomyocardial biopsy or rely on indirect diagnostic pathways. It is within this landscape that Bayer’s radiotracer cardiac amyloidosis program, built around iodine 124 evuzamitide, is advancing. What the REVEAL study measured The REVEAL study is a multicenter, open-label, single-arm Phase III trial conducted at 19 centers across the United States. It enrolled 170 adults with suspected cardiac amyloidosis and was sponsored by Brigham and Women’s Hospital in Boston as an investigator-initiated study. Participants received a single intravenous dose of I-124 evuzamitide, followed by PET/CT cardiac and partial-body imaging three to five hours post-injection. The primary endpoints were diagnostic sensitivity — the ability to correctly identify patients who have cardiac amyloidosis — and specificity — the ability to correctly identify those who do not. Both were assessed by visual PET/CT scan interpretation, with standard-of-care diagnosis serving as the reference standard. That reference diagnosis was adjudicated independently by clinical amyloidosis experts blinded to PET results, using routine diagnostic data collected up to 60 days after imaging. PET images were read by experienced cardiac PET physicians blinded to clinical data. Bayer announced that both primary endpoints were met. The company has not yet disclosed the numerical sensitivity and specificity values, stating that complete results will be presented at an upcoming scientific congress. Molecule and mechanism I-124 evuzamitide — also known as AT-01 and, in the scientific literature, as 124I-p5+14 — is a radiolabeled synthetic peptide that binds to extracellular amyloid deposits, including amyloid fibrils and associated glycosaminoglycans. Unlike 99mTc-PYP, which exploits a calcium-mediated binding mechanism that is selective for ATTR-type amyloid, evuzamitide’s p5+14 peptide scaffold binds amyloid fibrils across subtypes, making it a pan-amyloid agent capable of detecting both ATTR and AL cardiac involvement with a single scan. This pan-amyloid coverage is clinically relevant. A 2023 case report published in the Journal of Nuclear Cardiology described a patient with hereditary cardiac amyloidosis in whom 124I-AT-01 PET identified disease when both cardiac MRI and 99mTc-PYP SPECT scintigraphy were negative. That is a single case and cannot be generalized, but it illustrates the potential diagnostic reach of PET/CT cardiac amyloidosis imaging with a pan-amyloid tracer in cases where existing tools fall short. Beyond initial diagnosis, the quantitative nature of PET/CT imaging creates a potential role for evuzamitide in monitoring amyloid burden over time — a capability that current SPECT-based approaches cannot reliably provide. I-124 evuzamitide was originally developed by Attralus, Inc., which received FDA Breakthrough Therapy Designation for the compound in August 2024 for PET imaging in patients with suspected or known cardiac amyloidosis. Orphan Drug status was previously granted in both the US and EU for AL and ATTR amyloidosis. Bayer acquired the compound from Attralus in early 2026 as part of a transaction that also brought a second investigational amyloid radiotracer into its radiology pipeline. Bayer has stated it plans to discuss the REVEAL data and a regulatory submission pathway with the FDA and other health authorities. No submission timeline has been disclosed. The full REVEAL dataset will also be presented at an upcoming scientific congress, at which point the numerical sensitivity and specificity results, along with subtype-specific secondary analyses and safety data, will be available for independent evaluation. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.

Bayer is successfully executing on an ambitious growth strategy Five pivotal approvals worldwide in 2025 underscore a landmark year of strategic execution Bayer will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio, with multiple high-impact launches across oncology, cardiology, and women’s health Focus continues to accelerate a modality-rich pipeline across oncology, cardiology, neurology and immunology, complemented by existing high-value commercial products SAN FRANCISCO--(BUSINESS WIRE)--On the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco, Bayer AG today unveiled the strategic focus for its Pharmaceuticals Division in 2026. Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy. “We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years.” Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact. Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke. 1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high; one in five stroke survivors will have another stroke within five years. 3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke. 2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia ® ) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information . The European Commission granted marketing authorization for Beyonttra™ (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM. Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW. Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access. Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa ® (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information . Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo ® (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2 -mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2 -mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER 2-mutant NSCLC and in patients with metastatic solid tumors harboring HER 2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information. As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo ® ) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information . Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology. Menopause management: advancing care for women with diverse needs Bayer achieved a big step forward in women's health with the recent regulatory approvals of Lynkuet ® (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information . Developing a comprehensive cell and gene therapy (CGT) portfolio Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study. Radiology: Advancing innovation and expanding into Molecular Imaging Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1 Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29. 2 Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206. 3 Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935. 4 Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552. 5 Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42. Contacts Contact for media inquiries : Elaine Colón Phone +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com