Pentixapharm Holding AG announced at the EANM 2026 congress in Vienna that independent studies from Europe, Asia, and Australia continue to validate the use of [⁶⁸Ga]Ga-PentixaFor PET/CT in identifying unilateral primary aldosteronism, a common but underdiagnosed hormonal cause of high blood pressure. The accumulating data strengthen the rationale for the company’s pivotal Phase 3 PANDA study, which is designed to evaluate whether a simple scan can replace adrenal vein sampling—an invasive and burdensome catheter procedure—for subtyping the disease. The FDA has allowed the study to proceed and granted Fast Track designation, underscoring the unmet need for non-invasive diagnostic alternatives.
Primary aldosteronism affects a substantial proportion of hypertensive patients, and those with one-sided disease can benefit from surgical removal of the affected adrenal gland rather than lifelong medical therapy. However, identifying these patients currently requires adrenal vein sampling, which is technically challenging and not widely available. The PANDA study aims to demonstrate that Pentixafor PET can reliably detect one-sided disease, thereby sparing many patients the catheter procedure and enabling more targeted treatment decisions. Dr. Dirk Pleimes, CEO of Pentixapharm, emphasized the study’s clear question: “Can we use a simple imaging procedure to identify the patients who can be helped by surgery, and spare them the invasive and burdensome catheter examination required today?”
New data presented at EANM 2026 add to the growing body of evidence. The prospective PENTALON study from Paris (OP-048) contributed a French cohort, showing consistent results with independent studies from Australia (Monash study, Journal of Nuclear Medicine, 2026) and the Netherlands (CASTUS study). In the Monash study, Pentixafor PET identified one-sided disease with high specificity, was well tolerated, and was preferred by almost all patients over the catheter procedure. Larger datasets from China, generated independently of Pentixapharm, further complete the picture. These findings collectively support the diagnostic approach being tested in PANDA. Further congress information is available at https://eanm26.eanm.org/.
Beyond primary aldosteronism, Pentixapharm is advancing CXCR4-targeted programs in hemato-oncology. At EANM 2026, investigators from CHU Nantes and collaborating French centers are scheduled to present an interim analysis of [⁶⁸Ga]Ga-PentixaFor PET/CT for initial staging and treatment-response assessment in multiple myeloma (OP-875). These findings are particularly relevant to the company’s broader theranostic strategy, which aims to translate CXCR4-targeted imaging into precision radiopharmaceutical treatment. The planned Phase I/II PENTHERA program will investigate the combined use of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher for targeted bone marrow conditioning prior to stem cell transplantation in patients with multiple myeloma and acute myeloid leukemia.
The implications of the growing evidence are significant. If PANDA succeeds, Pentixafor PET could become the first non-invasive tool for subtyping primary aldosteronism, potentially reducing healthcare costs, improving patient comfort, and expanding access to surgical cure for thousands of patients worldwide. The Fast Track designation from the FDA highlights the potential of this approach to address a serious condition with limited diagnostic options. As preparations for the U.S.-centric Phase 3 study progress, Pentixapharm is positioning itself at the forefront of CXCR4-targeted diagnostics and therapeutics. The company’s pipeline, built on CXCR4 targeting, spans endocrine, cardiovascular, and oncological indications, with the lead program [⁶⁸Ga]Ga-PentixaFor advancing into registrational Phase 3. For more information, visit www.pentixapharm.com.
