Pentixapharm Receives FDA Fast Track Designation for Phase 3 Diagnostic Candidate [⁶⁸Ga]Ga-PentixaFor in Primary Aldosteronism

 

Pentixapharm Receives FDA Fast Track Designation for Phase 3 Diagnostic Candidate [⁶⁸Ga]Ga-PentixaFor in Primary Aldosteronism

 

• Fast Track designation complements the recent FDA clearance (“Study May Proceed”) of the pivotal U.S. Phase 3 PANDA study and supports closer regulatory interaction with the FDA
• [⁶⁸Ga]Ga-PentixaFor addresses a central diagnostic bottleneck in primary aldosteronism and hypertension: non-invasive subtyping to guide the treatment decision between surgery and chronic medical therapy
• Primary aldosteronism is a common and substantially underdiagnosed cause of hypertension, representing a large patient population with significant unmet diagnostic need

Berlin, Germany, 9 July 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotechnology company developing novel nuclear medicine diagnostics, received notice from the U.S. Food and Drug Administration (FDA) that Fast Track designation has been granted to its development candidate [⁶⁸Ga]Ga-PentixaFor for the diagnosis of patients with hypertension and underlying primary aldosteronism.

In its notification, the FDA determined that Pentixapharm’s request meets the criteria for Fast Track designation and that [⁶⁸Ga]Ga-PentixaFor is accordingly designated as a Fast Track product for the diagnostic subtyping of adult patients with confirmed primary aldosteronism. Fast Track designation is intended to facilitate the development and review of products that address serious conditions and have the potential to fill an unmet medical need. It provides opportunities for more frequent interaction with the FDA during development and may support a more efficient regulatory review process if the relevant criteria are met.

The practical benefit of Fast Track designation lies above all in closer and more frequent interaction with the FDA, allowing development and submission questions to be clarified early and the regulatory process to be prepared efficiently.

For Pentixapharm, Fast Track designation is an important regulatory signal. The FDA’s specific designation relates to the diagnostic subtyping of adult patients with already confirmed primary aldosteronism, precisely the clinical decision point at which physicians must distinguish between potential surgical treatment and long-term medical therapy.

The designation follows Pentixapharm’s recent announcement that the Investigational New Drug (IND) application for the U.S. Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor became effective following the FDA’s 30-day review period, with the FDA allowing the study to proceed (“Study May Proceed”).

“Fast Track designation is an important regulatory milestone for [⁶⁸Ga]Ga-PentixaFor and reinforces the strategic importance of PANDA as Pentixapharm’s lead value driver,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “It is particularly relevant that the FDA granted Fast Track designation explicitly for the diagnostic subtyping of adult patients with confirmed primary aldosteronism. In our view, this suggests that the FDA considers the unmet need for better diagnostic tools at this decisive point of patient care to be significant. Primary aldosteronism represents a large, underserved diagnostic opportunity with a clear clinical bottleneck: physicians need better tools to determine which patients may be eligible for surgery and which require long-term medical therapy. If approved, [⁶⁸Ga]Ga-PentixaFor could become the first molecular imaging agent specifically indicated for primary aldosteronism, helping physicians move beyond anatomical imaging toward a more biology-driven approach to diagnosis and treatment selection.”

Pentixapharm is preparing to initiate its pivotal Phase 3 PANDA study in the United States. PANDA is designed to evaluate [⁶⁸Ga]Ga-PentixaFor PET/CT as a non-invasive imaging approach to help identify patients with unilateral primary aldosteronism. This distinction is clinically important because unilateral disease may be treated with surgical removal of the affected adrenal gland in selected patients, while bilateral disease generally requires long-term medical therapy.

Primary aldosteronism is one of the most common and substantially underdiagnosed causes of secondary hypertension. The condition occurs when one or both adrenal glands produce too much aldosterone, a hormone that can drive high blood pressure and increase cardiovascular risk. For patients, the key treatment question is not only whether primary aldosteronism is present, but whether excess aldosterone production is coming from one adrenal gland or both. This makes accurate subtyping central to treatment selection and creates a major diagnostic bottleneck in the current care pathway.

[⁶⁸Ga]Ga-PentixaFor is designed to target CXCR4, a biological receptor shown to be strongly expressed in aldosterone-producing adrenal lesions. By visualizing CXCR4 expression with PET/CT, Pentixapharm aims to support a more precise and patient-friendly diagnostic pathway that can help physicians guide patients toward the appropriate treatment option.

About [⁶⁸Ga]Ga-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.

Pentixapharm is evaluating this established CXCR4 imaging approach in primary aldosteronism, where molecular characterization of adrenal lesions may help address limitations of conventional anatomical imaging. Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, supporting its potential relevance for identifying unilateral disease.

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 5–10% of all patients with hypertension and up to 20–30% of those with treatment-resistant hypertension.

Given the high prevalence of hypertension in the United States and globally, even modest improvements in PA detection and subtyping could translate into a meaningfully larger diagnosed and treatment-directed patient population. 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 cardiology, oncology and endocrinology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET/CT programs, including a Phase 3 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, regulatory developments, clinical development plans, financing initiatives, market opportunities 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, regulatory developments, the timing and outcome of interactions with regulatory authorities, clinical development risks, financing risks, changes in general economic and business conditions, competitive pressures, market acceptance of new products, services or technologies 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.

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