Biotechnology company Pentixapharm Holding AG (Frankfurt Prime Standard: PTP) on Wednesday reported further progress towards its pivotal Phase 3 PANDA study, with US ethics approval secured and no concerns raised by the US Food and Drug Administration (FDA) regarding the protocol submitted in August 2026. First patient enrolment remains expected in the first quarter of 2027, with no material impact on the study timeline anticipated.

The trial will enrol approximately 325 patients, with more than 10 US study sites selected and clinical investigators identified. Agreements with participating sites are being negotiated ahead of opening for enrolment. The FDA cleared the study to proceed in June 2026 and granted it Fast Track designation the following month.

PANDA will evaluate investigational radiopharmaceutical (68Ga)Ga-PentixaFor PET/CT as a non-invasive method of identifying disease subtypes in adults with confirmed primary aldosteronism, an underdiagnosed hormonal cause of high blood pressure. The approach could offer an alternative to adrenal vein sampling, an invasive procedure currently used to identify patients who may benefit from surgery.

Pentixapharm will publish its third-quarter and first nine-month 2026 results on 12 November 2026 and host a webcast at 3pm CET to discuss the results and PANDA study. The Berlin-based biotechnology company develops radiopharmaceutical diagnostics and therapies, with programmes targeting CXCR4 across endocrine, cardiovascular and oncology indications, alongside a next-generation antibody platform targeting CD24.