Pentixapharm Holding AG (Frankfurt Prime Standard: PTP) reported at the Annual Congress of the European Association of Nuclear Medicine (EANM 2026) in Vienna that growing international evidence supports the use of Pentixafor PET in primary aldosteronism, the indication for its pivotal Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor PET/CT. The data, presented by independent academic groups from Europe, Asia, and Australia, suggest that the imaging agent can identify patients with unilateral disease who may benefit from surgery, potentially reducing the need for adrenal vein sampling, an invasive catheter procedure that is the current standard of care.
“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. CXCR4 also remains central to our work in hemato-oncology, where we aim to combine imaging with targeted bone marrow conditioning before stem cell transplantation.”
The PANDA study is designed to evaluate [⁶⁸Ga]Ga-PentixaFor PET/CT for non-invasive subtyping in adults with confirmed primary aldosteronism in a registrational setting. Primary aldosteronism is a common, underdiagnosed hormonal cause of high blood pressure. Patients with one-sided disease can benefit from surgical removal of the affected adrenal gland instead of lifelong medical therapy, but identifying them currently requires adrenal vein sampling. The FDA confirmed in June 2026 that the study may proceed and granted Fast Track designation for this indication in July 2026.
At EANM 2026, the prospective PENTALON study from Paris (OP-048) added a French cohort to a consistent picture from independent studies on three continents. In the Monash study from Australia (Journal of Nuclear Medicine, 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. Together, these results support the approach of the Phase 3 PANDA study.
In hemato-oncology, 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 particularly relevant to Pentixapharm’s broader theranostic strategy, which aims to translate CXCR4-targeted imaging into precision radiopharmaceutical treatment. The planned Phase I/II PENTHERA clinical program will investigate the combined use of 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.
For investors and industry observers, the accumulating evidence from independent groups across three continents strengthens the rationale for PANDA and highlights the potential of CXCR4-targeted radiopharmaceuticals to address unmet needs in both endocrine and oncological indications. Further congress information is available at https://eanm26.eanm.org/, and details about the company can be found at www.pentixapharm.com.
