Hoth Therapeutics Secures Key European Regulatory Milestone with EMA Submission for Phase II Trial of HT-001 in Cancer Patients Suffering from EGFRi-Induced Skin Toxicities

Hoth Therapeutics has submitted a Clinical Trial Application to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001 for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). The submission marks a key regulatory milestone and unlocks the potential to address a vast oncology support market with no currently approved treatments. The EMA decision is expected in the coming months, and the Company expects to initiate European patient recruitment in early 2026.