Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced it has received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I of its HT-001 oncology clinical program. This decision confirms the scientific and regulatory acceptability of the trial design and investigational products. The company expects to activate clinical trial sites and initiate the study across multiple European countries. Country-specific Part II regulatory decisions in Hungary, Spain, and Poland are anticipated by January 19, 2026, supporting the program’s planned multi-national clinical execution. The HT-001 program targets cancer patients undergoing EGFR inhibitor therapies.

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