Pentixapharm's Phase 3 PANDA Study Gains International Momentum as New Data Support Non-Invasive Subtyping in Primary Aldosteronism

Pentixapharm's Phase 3 PANDA study for non-invasive subtyping of primary aldosteronism is reinforced by independent international data presented at EANM 2026, potentially eliminating the need for invasive adrenal vein sampling and guiding surgical decisions.

DC Metrowire Staff
••Healthcare
Pentixapharm's Phase 3 PANDA Study Gains International Momentum as New Data Support Non-Invasive Subtyping in Primary Aldosteronism

Pentixapharm Holding AG 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 announcement matters because it strengthens the rationale for a registrational study that could replace an invasive and burdensome diagnostic procedure with a simple scan, potentially transforming how patients with this common hormonal cause of high blood pressure are evaluated and treated.

Primary aldosteronism is a frequent but underdiagnosed cause of hypertension. 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, an invasive catheter procedure. The PANDA study is designed to evaluate whether [⁶⁸Ga]Ga-PentixaFor PET/CT can non-invasively identify these patients, sparing them the catheter examination. The FDA authorized the study to proceed in June 2026 and granted Fast Track designation in July 2026, and preparations in the United States are progressing.

At EANM 2026, new data from the prospective PENTALON study in Paris added a French cohort to a consistent picture from independent studies on three continents. The Monash study from Australia, published in the Journal of Nuclear Medicine in 2026, showed that 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 surgery decisions. Larger datasets from China, generated independently of Pentixapharm, complete the picture. These results collectively reinforce the approach of the Phase 3 PANDA study and suggest that the diagnostic paradigm could shift toward non-invasive imaging.

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. 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 combining PentixaFor imaging with [⁹⁰Y]Y-PentixaTher for targeted bone marrow conditioning before 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 the EANM 2026 data are significant. For patients with primary aldosteronism, a non-invasive test could reduce the burden and risk of adrenal vein sampling, which is technically challenging and not universally available. For Pentixapharm, the independent validation across Europe, Asia, and Australia de-risks the Phase 3 PANDA study and supports the company's CXCR4 platform. The Fast Track designation from the FDA underscores the unmet need and the potential of the approach. As the company advances preparations for PANDA, the growing body of evidence may accelerate the path to regulatory submission and, if successful, provide a new standard for subtyping primary aldosteronism. More information about Pentixapharm is available at www.pentixapharm.com.

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