Hoth Therapeutics submits CTA to EMA to expand Phase II trial of HT-001

Hoth Therapeutics (HOTH) announced it has submitted its Clinical Trial Application, or CTA, to the European Medicines Agency, or EMA, to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors, or EGFRi. The submission marks a major regulatory inflection point for Hoth, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments. Pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple U.S. sites.