Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation

Core Insights - Hoth Therapeutics has achieved a significant regulatory milestone in Europe for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies [1][2][3] - The company received a positive conclusion under the European Union Clinical Trials Information System (CTIS) for Part I, confirming the trial design and investigational products [2][3] - Hoth plans to activate clinical trial sites and initiate the study across multiple European countries, with country-specific decisions expected by January 19, 2026 [3][4] Regulatory and Clinical Development - The positive regulatory conclusion marks a critical inflection point for Hoth's oncology-focused pipeline, confirming the acceptability of their application for cancer-related indications [3][7] - The HT-001 program aims to address EGFRI-induced dermatologic toxicities, which are common complications for cancer patients and can negatively impact their quality of life [3][4] - The company anticipates rapid, multi-national clinical execution following the expected regulatory decisions in Hungary, Spain, and Poland [3][4] Operational Execution - Hoth expects to initiate patient enrollment and advance the HT-001 program into active clinical execution, representing a significant step toward validating a new supportive-care therapy for oncology patients [4][7] - The company is positioned for near-term regulatory and operational catalysts that will facilitate the progress of its clinical trials [7]