Hoth Therapeutics Inc Stock Price, News & Analysis

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.

Hoth Therapeutics (NASDAQ: HOTH) announced a virtual Key Opinion Leader (KOL) event scheduled for June 24, 2025, at 3:30PM EST, focusing on their novel therapy HT-001. The event will feature expert insights from Dr. Jonathan Hale Zippin and Dr. Adam Friedman, who will discuss interim results from the ongoing Phase 2 trial of HT-001, a topical treatment designed for EGFR inhibitor-induced skin toxicities in cancer patients. The specialists will explore how this innovative therapy could potentially transform supportive care standards in oncology. The virtual event will be accessible via Zoom.

Hoth Therapeutics (NASDAQ: HOTH) has successfully regained compliance with Nasdaq's minimum bid price requirement after its common stock maintained a closing price above $1.00 for 10 consecutive trading sessions from June 4-17, 2025. This achievement resolves the previous listing compliance issue, as confirmed by formal notice from the Nasdaq Listing Qualifications Department on June 18, 2025. CEO Robb Knie emphasized this milestone's significance, expressing confidence in the company's strategy and pipeline. The clinical-stage biopharmaceutical company is now positioned to focus on advancing its therapeutic portfolio across inflammatory diseases, oncology, and rare diseases, with expectations for key developments throughout 2025.

Hoth Therapeutics (NASDAQ: HOTH) reported positive preclinical safety data for its cancer therapeutic candidate HT-KIT. The multi-dose study demonstrated dose-dependent liver activity with no observable toxicity, marking a significant milestone toward clinical trials. Key findings showed liver weight increased from 1.11g to 1.32g across dosing from 0 to 3.0 mg/kg, with no adverse effects on kidney, spleen, thymus, or other organs. The study validated HT-KIT's safety profile in vivo with no visible lesions or gross pathology. CEO Robb Knie emphasized these results support their advancement toward GLP studies and IND submission, highlighting the clear biological response without organ damage as a positive indicator for the drug's development pathway.

Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, announced that CEO Robb Knie will attend the BIO International Convention in Boston from June 16-19, 2025. The event is recognized as the largest biotechnology convention globally, bringing together approximately 20,000 industry leaders from the biotech ecosystem. The BIO International Convention serves as a significant platform for networking and industry insights in the biotechnology sector.

Hoth Therapeutics (NASDAQ: HOTH) has secured Japanese Patent No. 7677628 for its HT-KIT platform technology, providing protection until August 27, 2039. The patent, titled "Targeting KIT with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells," covers their innovative approach using splice-switching oligonucleotides to disrupt KIT gene expression in mast cells. This technology targets conditions ranging from chronic hives to rare cancers. CEO Robb Knie highlighted the strategic importance of securing IP protection in Japan's pharmaceutical market, indicating potential licensing opportunities across Asia. The company is actively seeking strategic global partners for co-development and commercialization of the HT-KIT platform.

Hoth Therapeutics (NASDAQ: HOTH) has announced a significant advancement for its lead drug HT-001 by engaging Premier Research to support an Expanded Access Program (EAP) application. The initiative aims to provide compassionate access to HT-001 for cancer patients experiencing skin toxicities from EGFR inhibitor therapies. The company reports encouraging signals from their Phase 2a open-label cohort study. HT-001 addresses a significant market opportunity, with over 100,000 cancer patients annually receiving EGFR inhibitors, most of whom experience skin toxicities with no currently approved targeted treatments. The EAP status could accelerate commercialization while generating valuable real-world data. This strategic move positions Hoth to capture a growing segment in oncology supportive care while demonstrating their commitment to patient care.