Hoth Therapeutics submits CTA to EMA for HT-001 skin toxicity treatment.

Hoth Therapeutics has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its Phase II trial of HT-001, a topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). Pending EMA review and approval, the company expects to initiate European patient recruitment in early 2026. This marks a major regulatory inflection point for Hoth and reinforces its commitment to a global clinical strategy.

NEW YORK, Sept. 10, 2025 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced that 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). The submission marks a significant regulatory milestone for the company, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments 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^[1].

Pending EMA review and approval, Hoth Therapeutics expects to initiate European patient recruitment in early 2026, complementing the active enrollment already underway at multiple U.S. sites. The company's CEO, Robb Knie, expressed his satisfaction with the timely CTA submission, stating, "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" 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^[2].

Next on the horizon for Hoth Therapeutics are the EMA's expected decisions in the coming months, covering initial sites across three EU countries. Additionally, broader EU expansion is underway, with more sites targeted to accelerate patient enrollment. The U.S. Phase 2a trial is also progressing, evaluating the efficacy, safety, and tolerability of HT-001 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^[1].

Hoth Therapeutics is dedicated to advancing innovative, first-in-class therapies designed to improve patient quality of life. With a patient-centric approach and global development strategy, the company is actively pursuing breakthroughs in oncology supportive care and beyond 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^[2].

The submission of the CTA to the EMA is a significant step in Hoth Therapeutics' regulatory strategy, positioning the company to potentially bring a much-needed treatment to European patients suffering from EGFRi-induced skin toxicities. The success of this trial could have a substantial impact on the company's future financial prospects, especially if HT-001 proves to be an effective and safe treatment option.

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