Formal written minutes from the U.S. FDA confirms no major concerns identified for the planned Phase 3 PANDA study of [68Ga]Ga-PentixaFor in treatment-resistant hypertension and Primary Aldosteronism
Type B pre-IND meeting provided non-binding guidance on key statistical and methodological aspects, enabling refinement of the Phase 3 study design
Feedback clarifies evidence requirements relevant to a potential approval pathway, supporting the planned IND submission for the company's leading CXCR4-directed flagship program
BERLIN, DE / ACCESS Newswire / January 7, 2026 / Pentixapharm Holding AG (Frankfurt Prime Standard:PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that it has received the formal written minutes from its recent scientific advice meeting with the U.S. Food and Drug Administration (FDA) for the planned Phase 3 PANDA study of [68Ga]Ga-PentixaFor, the company's leading CXCR4-directed flagship program. The PANDA study will evaluate the radiodiagnostic as a potential new tool to improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism (PA). By enabling disease subtyping, PET/CT imaging with [68Ga]Ga-PentixaFor has the potential to better guide the most appropriate therapy, supporting more precise and effective treatment decisions.
The FDA's minutes provide further clarification on several important statistical, methodological aspects, and criteria for assessing diagnostic performance of the planned Phase 3 study and expand on the preliminary feedback from the meeting, previously communicated on December 3, 2025 .
"The FDA's formal written feedback provides important clarity on key design and analysis elements of our planned Phase 3 PANDA study with [68Ga]Ga-PentixaFor and confirms that no major concerns have been identified," said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. "Importantly, the feedback also provides guidance on the evidence requirements toward potential approval, including the role of confirmatory evidence in combination with this single Phase 3 study. This guidance strengthens our preparations for the planned IND submission and further supports the development of a potentially scalable, non-invasive diagnostic tool for patients with primary aldosteronism - the most common cause of secondary hypertension and a condition that remains significantly underdiagnosed."
About [ 68Ga]Ga-PentixaForin treatment-resistant hypertension and primary aldosteronism
[68Ga]Ga-PentixaFor is a novel, potentially first-in-class gallium-68-labeled radiodiagnostic designed to selectively target the chemokine receptor CXCR4 and to visualize its expression using high-resolution PET/CT imaging. Clinical experience with [68Ga]Ga-PentixaFor PET/CT is documented in more than 100 scientific publications encompassing over 2,600 patients across multiple indications, including more than 1,600 patients with primary aldosteronism. In published and ongoing studies, the diagnostic has demonstrated reproducible in vivo imaging of CXCR4 expression with a favorable safety profile.
Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically underdiagnosed cause of secondary hypertension, largely because reliably distinguishing unilateral from bilateral disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy. By visualizing CXCR4 expression in aldosterone-producing tissue, [68Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.
About Pentixapharm
Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.
Pentixapharm Investor and Media Contact
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SOURCE: Pentixapharm Holding AG
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/pentixapharm-receives-fda-feedback-for-phase-3-diagnostic-study-in-hy-1124880
