Pentixapharm Announces FDA Clearance of IND for Phase 3 PANDA Study of First-in-Class Cardiovascular Diagnostic Program

PRESSEMITTEILUNG / CORPORATE NEWS

Pentixapharm Announces FDA Clearance of IND for Phase 3 PANDA Study of First-in-Class Cardiovascular Diagnostic Program

 

Berlin, Germany, 09 June 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech developing novel radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying Primary Aldosteronism.

 

With the IND now in effect, Pentixapharm is authorized to initiate its U.S.-focused, multi-center Phase 3 PANDA clinical study evaluating its novel imaging approach for patient stratification in hypertension, addressing a significant and underdiagnosed segment within endocrine/cardiovascular disease and representing a key near-term value driver for the company.

 

The Phase 3 PANDA study has been designed based on prior interactions with the FDA, including formal feedback received in a Type B pre-IND meeting, which provided guidance on key statistical and methodological aspects as well as evidence requirements toward a potential approval pathway. The IND clearance confirms alignment with the FDA on the proposed study design and supports a registrational development strategy.

 

Pentixapharm’s CXCR4-targeted imaging platform represents a first-in-class approach in cardiovascular diagnostics, enabling non-invasive assessment of disease biology and supporting more precise treatment decisions in hypertensive patients. The program addresses a major unmet need in a large and rapidly evolving cardiovascular market, with the potential to improve diagnostic pathways and enable more targeted therapeutic intervention.

 

“This IND clearance represents a key execution milestone and confirms our ability to deliver on our regulatory strategy,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “With our flagship PANDA program now advancing into Phase 3 in the United States, we are entering the next phase of value creation. Primary aldosteronism affects up to 10% of patients with hypertension, yet remains significantly underdiagnosed. We believe our first-in-class PET/CT imaging approach has the potential to transform how these patients are identified and, importantly, to guide treatment decisions by enabling precise subtype differentiation. We are focused on rapid study initiation and disciplined execution, while actively engaging with potential strategic partners across imaging and cardiovascular therapeutics. In parallel, we are advancing financing initiatives to support Phase 3 execution and our continued expansion in the U.S. market.”

 

“The Phase 3 IND clearance is a critical milestone confirming that [⁶⁸Ga]Ga-PentixaFor has reached the technological maturity required for pivotal clinical execution,” said Erik Merten, Chief Technology Officer of Pentixapharm. “We have established a robust and scalable manufacturing and supply infrastructure and are well positioned to ensure reliable supply as we initiate the Phase 3 program and progress toward potential commercialization.”

 

About ⁶⁸Ga-PentixaFor in treatment-resistant hypertension and primary aldosteronism

[⁶⁸Ga]Ga-PentixaFor is a novel gallium-68-labeled radiodiagnostic designed to selectively target and visualize the chemokine receptor CXCR4 using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT in more than 2,000 patients across different indications has demonstrated its ability to non-invasively image CXCR4 expression in vivo.

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.

Primary Aldosteronism (PA) is increasingly recognized as one of the most common and significantly underdiagnosed endocrine disorders worldwide and a leading cause of secondary hypertension. Recent international and Endocrine Society guidelines have expanded recommendations for PA screening, reflecting growing evidence that the disease may affect approximately 5–14% of all patients with hypertension and up to 30% of those with resistant hypertension. As awareness, screening, and targeted treatment options continue to advance, the diagnostic landscape for PA is undergoing a fundamental transformation. This shift has the potential to expand the addressable patient population from a highly selected subgroup to millions of patients globally, creating a substantial opportunity for innovative diagnostic approaches aimed at improving disease detection, patient stratification, and treatment selection.

 

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.

 

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 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. 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.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com