EQS-News: Pentixapharm Announces IND Submission to FDA for Phase 3 PANDA Study of First-in-Class CXCR4-Targeted Cardiovascular Diagnostic

Pentixapharm Announces IND Submission to FDA for Phase 3 PANDA Study of First-in-Class CXCR4-Targeted Cardiovascular Diagnostic

• IND submitted to initiate Phase 3 PANDA diagnostic trial in the U.S. in hypertension with underlying primary aldosteronism
• First-in-class PET/CT imaging enabling treatment decisions through non-invasive subtype differentiation
• Strong market opportunity driven by underdiagnosis and increasing need for precision diagnostics in primary aldosteronism

Berlin, Germany, 11 May 2026 - Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech developing novel radiopharmaceuticals today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying Primary Aldosteronism.

The IND supports the initiation of the Pentixapharm’s U.S.-focused Phase 3 PANDA clinical trial evaluating its novel imaging approach to guide treatment decisions in primary aldosteronism, enabling precise subtype differentiation and selection of the appropriate therapeutic pathway, and representing a key near-term value driver for Pentixapharm.

The planned Phase 3 PANDA trial has been designed following 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 trial design is benchmarked against a performance standard derived from established guideline-based standards of diagnosis and is intended to support 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 the key decision-making process in hypertensive patients with underlying Primary Aldosteronism. The program is designed to address key limitations of adrenal venous sampling (AVS), a complex and invasive standard-of-care procedure, by offering a scalable, non-invasive imaging alternative with the potential to streamline diagnostic pathways and enable more targeted therapeutic intervention.

“This IND submission marks an important value inflection point as we advance our flagship PANDA program into late-stage clinical development in cardiovascular disease,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “We are executing a focused and capital-efficient strategy to bring our lead diagnostic asset into Phase 3 while continuing to advance a broader pipeline of CXCR4-targeted programs across cardiovascular and oncology indications. With regulatory alignment, we will be able to prepare for the next phase of clinical development and expand our strategic footprint in the United States, while engaging with potential partners and evaluating financing options to support this next stage of growth. We see significant market expansion in hypertension with underlying Primary Aldosteronism driven by increasing recognition of primary aldosteronism and the need for accurate subtype identification to guide treatment decisions.”

“Advancing into Phase 3 requires not only strong clinical and regulatory preparation, but also a robust and scalable manufacturing and supply infrastructure,” said Erik Merten, Chief Technology Officer of Pentixapharm. “We have been building the necessary CMC and GMP capabilities to ensure reliable supply as we move toward clinical execution and potential market entry, supported by our established isotope sourcing and GMP manufacturing and radiopharmaceutical networks.”

Following the IND submission, Pentixapharm is preparing for the initiation of its Phase 3 program in the United States, subject to FDA review. In parallel, the company continues to advance its manufacturing and supply infrastructure to support late-stage development and future commercialization.

Pentixapharm is also actively evaluating strategic partnerships with imaging companies, cardiovascular-focused pharmaceutical partners, and U.S.-based commercial organizations, alongside financing options to support Phase 3 execution and U.S. expansion.

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 2000 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 (lateralization) from bilateral (non-lateralizing) 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 a clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiovascular field to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs aimed at enabling precise, non-invasive molecular imaging across a range of high-unmet-need indications including treatment resistant hypertension with underlying Primary Aldosteronism and Multiple Myeloma.  CXCR4-based developments also include pioneering theranostic 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 (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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