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

Berlin, June 9, 2026 /PRNewswire/ Pentixapharm Holding AG announced that the U.S. FDA has cleared its IND for a CXCR4-targeted diagnostic program in treatment-resistant hypertension with underlying primary aldosteronism. The IND enables a US-focused, multi-center Phase 3 PANDA study evaluating imaging for patient stratification in hypertension, based on prior Type B pre-IND feedback from the FDA to refine statistical and methodological aspects. Pentixapharm's CXCR4-targeted imaging platform, using the radiopharmaceutical [68Ga]Ga-PentixaFor, represents a first-in-class approach to cardiovascular diagnostics aimed at improving diagnosis and guiding treatment decisions in hypertensive patients. Primary aldosteronism affects up to 10% of hypertension patients, with PANDA seeking a registrational pathway and rapid execution.