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NEW YORK - Hoth Therapeutics, Inc. (NASDAQ:HOTH), whose stock has surged nearly 10% in the past week and 95% year-to-date according to InvestingPro data, has submitted a Clinical Trial Application to the European Medicines Agency to expand its ongoing Phase II trial of HT-001, according to a press release issued Wednesday.
The company is developing HT-001 as a topical treatment for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi), which are used in cancer treatment. Currently, there are no approved treatments for this condition in either Europe or the United States. With a market capitalization of $19.36 million, Hoth has attracted analyst attention, with a consensus target price of $5.00 per share.
Pending EMA review and approval, Hoth expects to begin recruiting European patients in early 2026. The company already has patient enrollment underway at multiple U.S. sites for its Phase 2a trial, which is evaluating the efficacy, safety, and tolerability of HT-001.
"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, in the press release statement.
The initial European trial sites are expected to span three EU countries, with plans for additional sites to accelerate patient enrollment. The EMA decision on the application is anticipated in the coming months.
Hoth Therapeutics describes itself as a clinical-stage biopharmaceutical company focused on developing innovative therapies. The information in this article is based on a company press release. InvestingPro analysis indicates the company maintains a "GOOD" financial health score, with multiple additional insights available to subscribers. The stock currently appears slightly undervalued according to InvestingPro’s Fair Value model.
In other recent news, Hoth Therapeutics has reported significant progress in its drug development efforts. The company announced positive preclinical results for its precision antisense candidate HT-KIT, which demonstrated notable anti-tumor efficacy. Tumor cell death was observed within 24 hours of treatment, and significant tumor shrinkage occurred by day 8, with over 80% knockdown of KIT expression, a key cancer driver. Additionally, Hoth Therapeutics is expanding its Phase II clinical trial for HT-001 into European Union countries, seeking regulatory approval in up to three countries.
The company has also adopted Lantern Pharma’s PredictBBB.ai platform, an AI tool designed to predict blood-brain barrier permeability, enhancing the development of treatments for central nervous system conditions. In corporate developments, Hoth Therapeutics extended CEO Robb Knie’s contract, securing his leadership for at least three more years with potential annual bonuses and equity incentives. Furthermore, Hoth Therapeutics has partnered with the U.S. Department of Veterans Affairs to test GDNF therapy as a potential treatment for obesity and fatty liver disease. This collaboration will involve comparative studies at the Atlanta VA Medical Center.
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