Pentixapharm Holding AG today announced the positive feedback from the FDA ("study may proceed") for the initiation of the Phase III PANDA study with [⁶⁸Ga]Ga-PentixaFor. Subject to successful development and regulatory approval, the company sees an annual revenue potential of over one billion US dollars for [⁶⁸Ga]Ga-PentixaFor – driven by one of the largest unmet diagnostic needs at the intersection of hypertension, endocrinology, and precision medicine.

BERLIN, June 9, 2026 /PRNewswire/ -- Background: A Silent Mass Market and a Diagnostic Challenge 

High blood pressure is one of the most common and consequential widespread diseases worldwide. In the United States alone, Center for Disease Control (CDC) data shows nearly 120 million adults are affected – approximately 48% of the adult population. More than 87 million hypertensive patients are considered treatment-resistant or uncontrolled: they take medication but continue to suffer from hypertension.

A frequently overlooked cause driving treatment resistance is Primary Hyperaldosteronism (PA). Studies show that PA is responsible for 5–10% of all hypertensive patients – corresponding to approximately 6.5–7 million individuals in the United States.

PA and its subtypes remain chronically underdiagnosed today. In particular, adrenal vein sampling (AVS) – the invasive procedure used for treatment-defining diagnostics – is technically demanding and availability is restricted. The result: most PA patients receive lifelong medical treatment, even though a subset could be permanently cured through a single surgical procedure.

Pentixapharm's Solution: Simple, Cost-Efficient Diagnostics via PET/CT

With [⁶⁸Ga]Ga-PentixaFor, Pentixapharm offers a non-invasive diagnostic method: using a PET/CT scan, the precise locations in adrenal tissue responsible for excessive aldosterone production can be identified. This enables an accurate and cost-efficient differential diagnosis for determining whether a patient should undergo surgery or receive medical treatment.

Market Opportunity: Blockbuster Potential and Rapid Market Penetration

A recent example illustrates how rapidly innovative radiodiagnostics can gain traction: Since the initial US launch of diagnostic PSMA-PET scans for prostate cancer in 2021, the annual US revenues of the two leading providers, Lantheus Holding and Telix Pharmaceuticals, grew significantly and reached approximately USD 1.5 billion in 2024.

Several factors also support a rapid and sustainable market penetration for [⁶⁸Ga]Ga-PentixaFor:

• New Guidelines: AACE, AHA, ESE, ESH, ISH and the Primary Aldosteronism Foundation have actively recommended screening for Primary Hyperaldosteronism in all hypertensive patients since 2025.
• Low Barriers to Entry: The radiolabeling of [⁶⁸Ga]Ga-PentixaFor follows established standards (analogous to e.g. NETSPOT). Equipment and personnel are already available in most US radiopharmacies – no new investment required.
• Cost-Effectiveness and Patient Acceptance: [⁶⁸Ga]Ga-PentixaFor replaces a complex, invasive diagnostic procedure involving high radiation exposure with a PET/CT scan. In addition to greater patient acceptance, positive financial effects for payers are anticipated.
• Large Patient Population: In contrast to the PSMA market with approximately 30,000 annually treatable patients, the potential for [⁶⁸Ga]Ga-PentixaFor amounts to up to 6,5- 7 million patients in the United States alone.

Based on these factors, Pentixapharm sees significant commercial potential for [⁶⁸Ga]Ga-PentixaFor. Following successful clinical development and regulatory approval, the Executive Board believes that annual revenues could exceed the one billion US dollar threshold within several years after market launch.

Phase III PANDA Study: Setting the Course for Market Success 

Pentixapharm has received clearance from the US regulatory authority FDA to clinically evaluate PentixaFor in the United States. Starting in the second half of the year, the company will initiate the Phase III PANDA study – a large-scale, multi-center trial enrolling approximately 270 patients – to demonstrate that PentixaFor can replace and expand upon the existing diagnostic procedure.

Subject to the study proceeding as planned, the US market launch is scheduled for 2030.

About [⁶⁸Ga]Ga-PentixaFor

[⁶⁸Ga]Ga-PentixaFor is a gallium-68-labeled radiodiagnostic for the selective visualization of the chemokine receptor CXCR4 by means of high-resolution PET/CT imaging. Clinical experience in more than 2000 patients across various indications has confirmed its ability to non-invasively image CXCR4 expression in vivo.

About Pentixapharm

Pentixapharm Holding AG (Frankfurt Prime Standard: PTP) is a clinically advanced biotechnology company headquartered in Berlin. The company develops precision radiodiagnostics and -therapeutics in oncology and cardiology, anchored in CXCR4-targeted PET/CT programs. The pipeline is complemented by a CD24-based next-generation antibody platform and a reliable isotope supply network.

Contact Investor Relations & Media

ir@pentixapharm.com 

Forward-looking statements: This press release contains forward-looking statements based on current expectations and assumptions of  management. Actual results may differ materially. Pentixapharm Holding AG assumes no obligation to update these statements.

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SOURCE Pentixapharm Holding AG