Hoth Therapeutics Inc Stock Price, News & Analysis

Hoth Therapeutics (NASDAQ: HOTH) has announced its adoption of Lantern Pharma's PredictBBB.ai platform, an artificial intelligence tool boasting 94% accuracy in predicting blood-brain barrier permeability. This strategic move aims to enhance Hoth's drug development process by leveraging AI technology to determine whether drug candidates can effectively cross the blood-brain barrier.

The partnership with Lantern Pharma's RADR® AI platform positions Hoth to potentially accelerate drug development timelines, reduce risks, and streamline candidate selection. The technology addresses a major challenge in drug development while potentially creating faster regulatory pathways and higher value inflection points for Hoth's pipeline.

Hoth Therapeutics (NASDAQ: HOTH) reported significant preclinical milestones for its cancer therapeutic HT-KIT. The drug demonstrated potent anti-tumor activity in gastrointestinal stromal tumors (GIST) and systemic mastocytosis models, achieving over 80% knockdown of KIT expression and significant tumor shrinkage within 8 days.

The GLP-validated bioanalytical results, conducted by Altasciences, exceeded regulatory standards with 90.5% of ISR values within ±30% (above 66.7% requirement). The drug showed clean safety profiles across multiple organs and demonstrated extended stability in serum for 37 days at -80°C. The company is now advancing toward IND submission and first-in-human trials.

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.

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.