EQS-News: Pentixapharm Highlights Growing International Evidence Supporting Phase 3 PANDA Study in Primary Aldosteronism at EANM 2026

Pentixapharm Highlights Growing International Evidence Supporting Phase 3 PANDA Study in Primary Aldosteronism at EANM 2026

• Published research and new congress data from Europe and Asia show that Pentixafor PET can identify unilateral primary aldosteronism with high specificity, reinforcing the rationale for the Phase 3 PANDA study

• Multiple scientific contributions, mainly from independent academic groups in Europe and Asia, reflect strong interest in CXCR4, the biological target of Pentixapharm’s diagnostic and therapeutic programs

• Pentixapharm advances preparations for its pivotal U.S.-centric Phase 3 PANDA study, authorized to proceed by the FDA and designed to evaluate non-invasive subtyping to help guide the choice between surgery and medical treatment in hypertensive patients with underlying primary aldosteronism

Berlin, Germany, October 19, 2026 - Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotechnology company developing radiopharmaceutical diagnostics and therapeutics, today reported that data being presented at the Annual Congress of the European Association of Nuclear Medicine (EANM 2026) in Vienna add to the growing international evidence for Pentixafor PET in primary aldosteronism, the indication of its pivotal Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor PET/CT. The aim is to identify, with a simple scan, the patients with one-sided disease who can benefit from surgery, and to reduce the need for adrenal vein sampling, the current standard of care and an invasive catheter procedure.

“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.”

PANDA and the international evidence

PANDA 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 with mineralocorticoid receptor antagonists or aldosterone synthase inhibitors, 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. Preparations for the study in the United States are progressing.

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, the 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.

Hemato-oncology: multiple myeloma and PENTHERA

In multiple myeloma, 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 on October 21 (OP-875). The presentation contributes to the growing clinical evidence supporting CXCR4-targeted molecular imaging in hematological malignancies.

These findings are particularly relevant to Pentixapharm’s broader theranostic strategy, which aims to translate CXCR4-targeted imaging into precision radiopharmaceutical treatment.Pentixapharm’s 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.

PentixaFor and PentixaTher are investigational radiopharmaceutical candidates. Further congress information is available at https://eanm26.eanm.org/.

About Pentixapharm

Pentixapharm Holding AG (Frankfurt Prime Standard: PTP) is a clinical-stage biotechnology company headquartered in Berlin developing innovative nuclear medicine approaches to help physicians detect, characterize, and treat serious diseases with greater precision. The Company’s compounds are designed to deliver medical radioisotopes specifically to defined biological targets - either for high-resolution molecular imaging or for targeted radioligand therapy.

Pentixapharm’s pipeline is built on CXCR4 targeting, a receptor with strong scientific validation across multiple disease areas, and encompasses diagnostic and therapeutic programs in endocrine, cardiovascular, and oncological indications. The lead program, [⁶⁸Ga]Ga-PentixaFor, is being advanced into the registrational Phase 3 PANDA study for non-invasive subtyping of primary aldosteronism. The PENTHERA program advances the CXCR4-directed theranostic platform into Phase I/II in oncology. Complementing the CXCR4 platform, Pentixapharm is also developing a next-generation antibody platform targeting CD24, an emerging immune checkpoint in difficult-to-treat cancers.

Forward-looking statements

This press release contains forward-looking statements based on the current beliefs, expectations and assumptions of the management of Pentixapharm Holding AG. These statements relate to future events, prospects or financial performance and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially, positively or negatively, from those expressed or implied by such forward-looking statements. Such factors include, among others, changes in general economic and business conditions, competitive pressures, the introduction of competing products, limited market acceptance of new products, services or technologies, regulatory developments and changes in business strategy. Pentixapharm Holding AG does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Forward-looking statements are made only as of the date of this press release. All information provided in this press release is supplied without any warranty or guarantee as to its accuracy, completeness or timeliness. To the extent permitted by law, Pentixapharm Holding AG assumes no liability in connection with this press release.

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