On September 10, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, reported it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (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 (EGFRi) (Press release, Hoth Therapeutics, SEP 10, 2025, View Source [SID1234655927]).
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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.
CEO Commentary
"We are very pleased with the timely CTA submission to the EMA, a pivotal step in advancing our international development of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Skin toxicities from EGFRi therapies remain an urgent, unmet medical need, and with no FDA or EMA-approved treatment available, advancing HT-001 in Europe represents a powerful opportunity to improve patient quality of life and drive meaningful value creation for shareholders."
Next Catalysts on Horizon
EMA Decision Expected in Coming Months covering initial sites across three EU countries.
Broader EU Expansion underway, with additional sites targeted to accelerate patient enrollment.
U.S. Phase 2a Trial Progressing – evaluating efficacy, safety, and tolerability of HT-001.