Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

EQS-News: Pentixapharm Holding AG / Key word(s): Study Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension (news with additional features) 07.01.2026 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement. Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

 

• Formal written minutes from the U.S. FDA confirms no major concerns identified for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor in treatment-resistant hypertension and Primary Aldosteronism

• Type B pre-IND meeting provided non-binding guidance on key statistical and methodological aspects, enabling refinement of the Phase 3 study design

• Feedback clarifies evidence requirements relevant to a potential approval pathway, supporting the planned IND submission for the company’s leading CXCR4-directed flagship program

 

Berlin, Germany, January 07, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that it has received the formal written minutes from its recent scientific advice meeting with the U.S. Food and Drug Administration (FDA) for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor, the company’s leading CXCR4-directed flagship program. The PANDA study will evaluate the radiodiagnostic as a potential new tool to improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism (PA). By enabling disease subtyping, PET/CT imaging with [⁶⁸Ga]Ga-PentixaFor has the potential to better guide the most appropriate therapy, supporting more precise and effective treatment decisions.

The FDA’s minutes provide further clarification on several important statistical,  methodological aspects, and criteria for assessing diagnostic performance of the planned Phase 3 study and expand on the preliminary feedback from the meeting,  previously communicated on December 3, 2025.

“The FDA’s formal written feedback provides important clarity on key design and analysis elements of our planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor and confirms that no major concerns have been identified,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “Importantly, the feedback also provides guidance on the evidence requirements toward potential approval, including the role of confirmatory evidence in combination with this single Phase 3 study. This guidance strengthens our preparations for the planned IND submission and further supports the development of a potentially scalable, non-invasive diagnostic tool for patients with primary aldosteronism – the most common cause of secondary hypertension and a condition that remains significantly underdiagnosed.”