Pentixapharm Holding (Frankfurt Prime Standard: PTP) has announced that the FDA has cleared its Investigational New Drug (IND) application for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying primary aldosteronism.
According to Pentixapharm, the clearance authorizes the company to initiate its U.S.-focused, multi-center Phase 3 PANDA clinical study evaluating its novel imaging approach for patient stratification in hypertension.
In a statement, Dirk Pleimes, CEO of Pentixapharm, commented, “This IND clearance represents a key execution milestone and confirms our ability to deliver on our regulatory strategy. With our flagship PANDA program now advancing into Phase 3 in the U.S., we are entering the next phase of value creation. Primary aldosteronism affects up to 10% of patients with hypertension, yet remains significantly underdiagnosed. We believe our first-in-class PET/CT imaging approach has the potential to transform how these patients are identified and, importantly, to guide treatment decisions by enabling precise subtype differentiation. We are focused on rapid study initiation and disciplined execution, while actively engaging with potential strategic partners across imaging and cardiovascular therapeutics. In parallel, we are advancing financing initiatives to support Phase 3 execution and our continued expansion in the U.S. market.”
