Pentixapharm Announces Progress of Pivotal Phase 3 PANDA Study; Will Host Third Quarter Webcast on November 12, 2026

(FSE:PTP) Pentixapharm Holding AG announced completion of further key preparations for the pivotal Phase 3 PANDA study. The company will publish its third quarter and first nine months 2026 results on November 12, 2026. The PANDA study is designed to enroll approximately 325 patients. More than ten U.S. study sites have already been selected, including leading academic medical centers and a specialized adrenal center. Clinical investigators have been identified to conduct the study. Agreements with participating study sites are currently being negotiated to enable site openings for patient enrollment. The FDA confirmed in June 2026 that the PANDA study could proceed and granted Fast Track designation in July 2026. The FDA raised no concerns regarding the study protocol submitted in August 2026, which specifies the primary endpoints and the planned number of patients. The central U.S. ethics committee (Institutional Review Board) has approved the study protocol and consent documents. First patient enrollment is expected in the first quarter of 2027. The company does not expect any material impact on the further timeline of the study. A webcast to discuss third quarter and first nine months 2026 results and progress on PANDA will be held on November 12, 2026, at 3:00 p.m. CET. The PANDA study will evaluate [68 Ga]Ga-PentixaFor PET/CT for non-invasive subtyping in adults with confirmed primary aldosteronism. Independent studies from Europe, Asia, and Australia, most recently presented at EANM 2026, support the PANDA approach. Pentixapharm's pipeline is built on CXCR4 targeting and includes diagnostic and therapeutic programs in endocrine, cardiovascular, and oncological indications. The lead program, [68 Ga]Ga-PentixaFor, is being advanced into the registrational Phase 3 PANDA study. The PENTHERA program advances the CXCR4-directed theranostic platform into Phase I/II in oncology. Pentixapharm is also developing a next-generation antibody platform targeting CD24.