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

EQS-News: Pentixapharm Holding AG / Key word(s): Study Pentixapharm Announces FDA Clearance of IND for Phase 3 PANDA Study of First-in-Class Cardiovascular Diagnostic Program 09.06.2026 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement. 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.

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