Pentixapharm Advances Regulatory Preparations for Phase 3 PANDA Study with Radiodiagnostic Candidate 68Ga-PentixaFor in Hypertension

EQS-News: Pentixapharm Holding AG / Key word(s): Study Pentixapharm Advances Regulatory Preparations for Phase 3 PANDA Study with Radiodiagnostic Candidate 68Ga-PentixaFor in Hypertension (news with additional features) 03.12.2025 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement. Pentixapharm Advances Regulatory Preparations for Phase 3 PANDA Study with Radiodiagnostic Candidate 68Ga-PentixaFor in Hypertension

 

• FDA scientific advice meeting provides guidance on planned Phase 3 study of radiodiagnostic lead candidate in treatment-resistant hypertension / primary aldosteronism
• Further details on Phase 3 clinical setup expected upon receipt of the FDA’s official meeting minutes

 

Berlin, Germany, December 03, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech developing first-in-class radiopharmaceuticals, has received encouraging feedback from a TypeB pre‑IND meeting with the U.S. Food and Drug Administration (FDA). The discussion addressed key elements of Pentixapharm’s planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor, a CXCR4-directed radiodiagnostic intended to significantly improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism. Despite its substantial clinical and societal impact, primary aldosteronism remains widely underdiagnosed, and earlier, more accurate detection represents a significant unmet medical need.

During the meeting, the FDA provided initial, non-binding feedback on key components of Pentixapharm’s draft Phase 3 clinical protocol, including proposed inclusion criteria and design as well as statistical parameters. The FDA’s input is considered essential for the Phase 3 study to meet effectiveness and shaping the final Investigational New Drug (IND) submission.

“We appreciate the constructive dialogue with the FDA and the opportunity to align on technical details and clarify outstanding questions,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “The preliminary feedback supports our plan to advance [⁶⁸Ga]Ga-PentixaFor into Phase 3 and provides an important step toward bringing a potentially scalable and non-invasive diagnostic tool to patients with primary aldosteronism who currently lack reliable, non-invasive options. Once we have received and reviewed the formal FDA meeting minutes, we will refine our Phase 3 study design accordingly and continue to update the market as we progress along our IND strategy.”