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 [Yahoo! Finance...
Hoth Therapeutics, Inc. (HOTH)
Company Research
Source: Yahoo! Finance
innovator, today announced 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). (PRNewsfoto/Hoth Therapeutics Inc.) 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 remai
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HOTH
News
- Hoth Therapeutics (NASDAQ:HOTH) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $5.00 price target on the stock.MarketBeat
- Hoth Therapeutics Issues Comprehensive Pipeline Update Highlighting Clinical Progress, Orphan-Designated HT-KIT, Advancing HT-001 Phase 2, and New GDNF Metabolic ProgramPR Newswire
- Hoth Therapeutics to Present at Noble Capital Markets 21st Annual Emerging Growth Equity Conference, December 2-3, 2025 [Yahoo! Finance]Yahoo! Finance
- Hoth Therapeutics to Present at Noble Capital Markets 21st Annual Emerging Growth Equity Conference, December 2-3, 2025PR Newswire
- Hoth Therapeutics Accepted Into NVIDIA Connect Program, Expanding Its AI and Accelerated Computing Capabilities [Yahoo! Finance]Yahoo! Finance
HOTH
Sec Filings
- 12/5/25 - Form EFFECT
- 11/17/25 - Form S-3
- 11/13/25 - Form 424B5
- HOTH's page on the SEC website