Pentixapharm Holding AG has reported new data at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna that strengthen the case for its investigational PET imaging agent, [⁶⁸Ga]Ga-PentixaFor, in primary aldosteronism. The findings, which come from independent academic groups across Europe, Asia, and Australia, support the design of the company’s pivotal Phase 3 PANDA study and could fundamentally change how patients with this common hormonal cause of high blood pressure are evaluated and treated.
Primary aldosteronism affects a substantial proportion of people with hypertension, yet it remains underdiagnosed. For patients with one-sided, or unilateral, disease, surgical removal of the affected adrenal gland can offer a cure, sparing them from lifelong medication. However, identifying these patients currently requires adrenal vein sampling—an invasive and technically demanding catheter procedure that is not widely available. Pentixafor PET/CT, which targets the CXCR4 receptor, aims to provide a non-invasive alternative. “Our pivotal Phase 3 study PANDA will answer a 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?” said Dr. Dirk Pleimes, Chief Executive Officer of Pentixapharm.
The data presented at EANM 2026 add to a growing body of evidence. The prospective PENTALON study from Paris (OP-048) introduced a French cohort, showing that Pentixafor PET can identify unilateral disease even when it is not visible on CT. In the Monash study from Australia, published in the Journal of Nuclear Medicine, Pentixafor PET demonstrated high specificity, was well tolerated, and was preferred by almost all patients over the catheter procedure. The first stage of the CASTUS study in the Netherlands pointed in the same direction, and larger independent datasets from China complete the picture across three continents. Together, these results reinforce the rationale for PANDA, which the U.S. Food and Drug Administration (FDA) authorized to proceed in June 2026 and granted Fast Track designation in July 2026. Preparations for the U.S.-centric study are progressing.
Beyond primary aldosteronism, Pentixapharm is advancing CXCR4-targeted programs in hemato-oncology. At the congress, 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 on October 21 (OP-875). These findings are relevant to the company’s broader theranostic strategy, which combines imaging with targeted therapy. The planned Phase I/II PENTHERA program will investigate PentixaFor imaging to identify CXCR4-expressing disease and [⁹⁰Y]Y-PentixaTher for targeted bone marrow conditioning prior to stem cell transplantation in patients with multiple myeloma and acute myeloid leukemia. Further congress information is available at https://eanm26.eanm.org/.
The implications of these developments are significant. If validated in the Phase 3 PANDA study, Pentixafor PET could become the first non-invasive tool for subtyping primary aldosteronism, potentially reducing reliance on adrenal vein sampling and improving access to surgical cure for thousands of patients. The growing independent evidence also underscores the scientific validation of CXCR4 as a target across multiple disease areas. Pentixapharm’s pipeline, built on this platform, spans endocrine, cardiovascular, and oncological indications, with the lead program now advancing into registrational Phase 3. For more information about the company, visit www.pentixapharm.com. The original release is available at www.newmediawire.com.
