Pentixapharm Holding AG, a clinical-stage biotechnology company based in Berlin, announced at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna that new and published data from independent research groups in Europe, Asia, and Australia increasingly support the use of Pentixafor PET in primary aldosteronism. The findings reinforce the rationale for the company's pivotal Phase 3 PANDA study, which is designed to evaluate non-invasive subtyping of the condition and help guide the choice between surgery and medical treatment.
Primary aldosteronism is a common but underdiagnosed hormonal cause of high blood pressure. Patients with one-sided, or unilateral, disease can benefit from surgical removal of the affected adrenal gland instead of lifelong medical therapy. However, identifying these patients currently requires adrenal vein sampling, an invasive catheter procedure. Pentixapharm's approach uses [⁶⁸Ga]Ga-PentixaFor PET/CT to identify, with a simple scan, the patients who can benefit from surgery, potentially reducing the need for the catheter examination.
At EANM 2026, the prospective PENTALON study from Paris added a French cohort to a consistent picture from independent studies on three continents. In the Monash study from Australia, published in the Journal of Nuclear Medicine in 2026, Pentixafor PET identified one-sided disease with 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. In PENTALON, where the disease was often not visible on CT, investigators see a clinical role for Pentixafor PET in sparing selected patients the catheter procedure and in supporting decisions on surgery. Larger datasets from China, generated independently of Pentixapharm, complete the picture.
"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. "Data from independent groups in Europe, Asia and Australia increasingly point in this direction, and our preparations for PANDA in the U.S. are in full swing."
The FDA confirmed in June 2026 that the PANDA study may proceed and granted Fast Track designation for this indication in July 2026. Preparations for the U.S.-centric study are progressing. For readers and investors, the growing body of independent evidence is significant because it supports the scientific rationale behind a registrational trial that, if successful, could change the standard of care for a common cause of hypertension. The availability of a non-invasive alternative to adrenal vein sampling could reduce patient burden and improve access to appropriate surgical treatment. Further congress information is available at https://eanm26.eanm.org/, and details about the company can be found at www.pentixapharm.com.
Beyond primary aldosteronism, Pentixapharm is advancing CXCR4-targeted programs in hemato-oncology. At the same 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. These findings are 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 before stem cell transplantation in patients with multiple myeloma and acute myeloid leukemia. PentixaFor and PentixaTher are investigational radiopharmaceutical candidates.
