Hoth Therapeutics Inc Stock Price, News & Analysis

Hoth Therapeutics (NASDAQ: HOTH) announced that CEO Robb Knie will present at BIO-Europe 2025 in Vienna, Austria, on November 3–5, 2025. The presentation will highlight progress on two clinical programs: HT-001, a topical treatment for rash and skin toxicity from cancer therapies including EGFR inhibitors and radiotherapy, and HT-KIT, a precision oncology program targeting KIT-driven tumors.

The company said it will discuss clinical pipeline updates and engage with potential collaborators. Presentation timing and partnering meetings will be available to registered attendees via the BIO-Europe partneringONE platform.

Hoth Therapeutics (NASDAQ: HOTH) has expanded its intellectual property portfolio for HT-001, its lead topical therapeutic candidate, by filing multiple U.S. Provisional Patent Applications. The patents cover three new indications: drug-induced hypersensitivity syndrome, radiotherapy-induced rash, and dermatological conditions associated with MENIN inhibitor therapy.

The expansion particularly focuses on addressing skin toxicities associated with MENIN inhibitors, an emerging class of targeted oncology drugs showing promise in treating acute leukemias and solid tumors. HT-001's novel topical formulation aims to help patients manage treatment-related skin conditions without interrupting their cancer therapy, potentially enabling longer treatment duration and better clinical outcomes.

Hoth Therapeutics (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, announced significant progress across multiple programs. The company's lead candidate HT-001 is expanding globally with a Clinical Trial Application submitted to EMA for Phase II trials. Their HT-KIT program completed GLP bioanalytical phase, while a new VA obesity program targets veteran health challenges.

In a strategic move, Hoth's board approved a treasury reserve expansion to include up to $1 million in Bitcoin, Ethereum, and Solana. The company has also partnered with ICON Clinical Research for EU trial expansion and integrated Lantern Pharma's AI platform achieving 94% predictive accuracy for blood-brain barrier permeability.

Hoth Therapeutics (NASDAQ: HOTH) has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its Phase II trial of HT-001, a topical treatment for skin toxicities caused by Epidermal Growth Factor Receptor inhibitors (EGFRi) in cancer patients.

The company aims to expand its ongoing Phase II trial into Europe, with patient recruitment expected to begin in early 2026. This expansion complements existing U.S. trial sites. The submission represents a significant milestone as there are currently no FDA or EMA-approved treatments for EGFRi-induced skin toxicities.

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.