Welcome to our dedicated page for Hoth Therapeutics news (Ticker: HOTH), a resource for investors and traders seeking the latest updates and insights on Hoth Therapeutics stock.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a clinical-stage biopharmaceutical company whose news flow is centered on the development of therapies for oncology, dermatology, neurodegenerative disease, metabolic disease, and inflammatory conditions. Company updates frequently highlight progress across its pipeline, including HT-001 for cancer-therapy–related skin toxicities, HT-KIT for KIT-driven cancers and mast-cell diseases, HT-ALZ for Alzheimer’s disease, and a GDNF-based metabolic program targeting obesity and fatty liver disease.
News releases from Hoth often cover clinical milestones such as Phase 2 trial activity for HT-001 in EGFR-inhibitor–associated rash, first-in-human study preparations, and regulatory developments in the European Union and the United States. The company also reports on FDA designations, including Orphan Drug Designation for HT-KIT, and on IND-enabling progress and preclinical data in systemic mastocytosis and GIST models.
Investors and followers of HOTH stock can also expect updates on intellectual property expansion, including provisional patent filings and international patent protection related to HT-001 and other programs. Hoth regularly announces collaborations and research partnerships, such as its VA-backed GDNF study at the Atlanta VA Medical Center and participation in NVIDIA’s AI-focused programs to support computational biology and predictive modeling.
This news page aggregates Hoth Therapeutics’ press releases and related coverage, providing a single place to review developments in its clinical trials, regulatory interactions, AI-enabled research initiatives, conference presentations, and corporate communications. Readers interested in the evolution of HOTH’s pipeline and regulatory strategy can use this feed to monitor ongoing announcements and historical updates.
Hoth Therapeutics (NASDAQ: HOTH) has announced the expansion of its Phase II clinical trial for HT-001 into European Union countries, partnering with ICON Clinical Research Limited. The trial focuses on treating skin toxicities in cancer patients associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).
The company expects regulatory approval from three EU countries in the coming months, while continuing patient enrollment at multiple U.S. sites. This Phase 2a study aims to evaluate the efficacy, safety, and proper dosing of topical HT-001. The expansion aligns with Hoth's international clinical development strategy and sets the foundation for a future global Phase III trial.
Hoth Therapeutics (NASDAQ: HOTH) has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and FAVER to study GDNF as a potential treatment for obesity and fatty liver disease.
The research will be conducted at the Atlanta VA Medical Center through a dual-arm study comparing GDNF against semaglutide. The first arm will evaluate GDNF in Western diet-fed mice, while the second arm will test GDNF in human hepatocyte-engrafted mice. Under the agreement, Hoth will fund the study and provide GDNF, with the VA maintaining data rights.
GDNF has previously shown promise in reducing body weight, enhancing insulin sensitivity, and promoting fatty acid oxidation. This study represents the first pharmacologic test of GDNF in human liver-engrafted mice, potentially expanding its applications beyond CNS indications.
Hoth Therapeutics (NASDAQ: HOTH) and Silo Pharma (NASDAQ: SILO) have formed a 50/50 joint venture to develop and commercialize a novel obesity treatment licensed from the U.S. Department of Veterans Affairs. The therapy is based on Glial Cell Line-Derived Neurotrophic Factor (GDNF), targeting obesity and non-alcoholic fatty liver disease (NAFLD).
The technology, protected under U.S. Patent No. 10,052,362, aims to address a $100B+ market with potential applications for type 2 diabetes and central obesity. The partnership combines the VA's clinical infrastructure, Hoth's regulatory expertise, and Silo's translational capabilities to develop this first-in-class treatment targeting the neuroinflammatory root of obesity.
Hoth Therapeutics (NASDAQ: HOTH) announced breakthrough interim results for its HT-001 Phase 2a clinical trial, achieving a 100% response rate in at least one primary endpoint for treating EGFR inhibitor-induced skin toxicities. The trial demonstrated that over 65% of patients reported reduced pain and itching, with no patients requiring dose reduction or discontinuation of their cancer treatment.
HT-001, a once-daily topical gel containing an FDA-approved NK1 receptor antagonist, targets inflammatory pathways triggered by EGFR inhibition. The therapy showed significant efficacy in preclinical studies and is being developed under the 505(b)(2) regulatory pathway, positioning it to potentially become the first FDA-approved treatment specifically for EGFRI-related skin toxicities, which affect up to 90% of cancer patients receiving EGFR inhibitors.