Pentixapharm Receives FDA Feedback for Hypertension Study

Pentixapharm Holding AG has received feedback from the U.S. FDA on its planned Phase 3 PANDA study for [⁶⁸Ga]Ga-PentixaFor, targeting treatment-resistant hypertension and Primary Aldosteronism. The FDA has raised no major concerns, offering guidance on statistical and methodological aspects crucial for refining the study design.

The formal feedback aligns with previous discussions, ensuring vital clarity on the evidence needed for potential approval. This progress aids the company's preparations for an Investigational New Drug (IND) submission, focusing on a scalable diagnostic tool for Primary Aldosteronism, a frequent but underdiagnosed secondary hypertension cause.

Pentixapharm seeks to enhance diagnostic pathways with [⁶⁸Ga]Ga-PentixaFor, aiming to improve treatment decisions through better disease subtyping via PET/CT imaging. The FDA's feedback is a significant step towards advancing this novel radiopharmaceutical into clinical use.