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 advancing novel therapies for dermatological conditions, oncology targets, and neurodegenerative disorders. This news hub provides investors and researchers with timely updates on clinical trial progress, regulatory milestones, and strategic partnerships central to evaluating Hoth’s therapeutic pipeline.
Discover authoritative coverage of Hoth’s innovative platforms including the BioLexa antimicrobial system and HT-ALZ for Alzheimer’s research. Our curated news collection features press releases on FDA designations, preclinical data disclosures, and licensing agreements with academic institutions like George Washington University and North Carolina State University.
Key updates include developments across three core areas: dermatology (eczema/chronic wound treatments), oncology (HT-KIT for mast cell cancers), and neurology (neuroinflammation targeting). Each news item is verified for accuracy to support informed analysis of Hoth’s research trajectory and market position.
Bookmark this page for consolidated access to Hoth Therapeutics’ latest announcements, including earnings reports, intellectual property filings, and collaborative research initiatives. Regularly updated to serve as your primary resource for tracking this innovative biopharma’s progress in addressing unmet medical needs.
Hoth Therapeutics (NASDAQ: HOTH) issued a pipeline update highlighting clinical and preclinical progress across four programs: HT-001 (topical EGFR-inhibitor rash therapy) is in Phase 2 CLEER-001 with a reported strong safety profile and consistent improvement trends; HT-KIT received FDA Orphan Drug Designation and is completing IND-enabling toxicology with an IND targeted in 2026; HT-ALZ is progressing GLP, PK, and CNS-penetration work toward a regulatory package in 2026; and a newly launched GDNF-based metabolic program (collaboration with Atlanta VA) has begun preclinical work with early data expected in 2026.
The company also reports manufacturing scale-up, expanded IP filings, and ongoing academic and AI-assisted collaborations, with near-term milestones including CLEER-001 data updates and HT-KIT IND completion.
Hoth Therapeutics (NASDAQ: HOTH) announced that Chief Executive Officer Robb Knie is scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference (NobleCon) in Boca Raton, FL.
The conference runs December 2–3, 2025; the company provided registration and one-on-one meeting details via the NobleCon website for investors and attendees.
Hoth Therapeutics (NASDAQ: HOTH) announced acceptance into the NVIDIA Connect Program on November 20, 2025.
Participation provides access to NVIDIA GPU-accelerated developer tools, SDKs/APIs, technical guidance, and co-marketing support to support computational-biology workflows such as target identification, protein-structure modeling, and preclinical data analytics for programs including HT-001, HT-KIT, HT-ALZ, and metabolic-disease initiatives.
The company said the program is expected to reduce computational bottlenecks, speed modeling, and strengthen AI-driven R&D and decision-making.
Hoth Therapeutics (NASDAQ: HOTH) announced a VA-backed research program to evaluate glial cell line–derived neurotrophic factor (GDNF) as a potential first-in-class biologic for obesity and nonalcoholic fatty liver disease (NAFLD).
The study, led by Dr. Srinivasan at the Atlanta VA Medical Center, begins diet group work in October 2025, starts GDNF and comparator dosing in December 2025, with tissue collection and analysis in January 2026 and initial results expected Q1 2026. Positive results could support IND-enabling development targeting both weight loss and hepatic steatosis through metabolic and neurotrophic mechanisms.
Hoth Therapeutics (NASDAQ: HOTH) announced FDA Orphan Drug Designation for HT-KIT and presented preclinical results showing >80% KIT mRNA/protein suppression and statistically significant tumor-volume reduction by Day 8 in systemic mastocytosis and GIST models. GLP-validated bioanalytical methods are complete to support IND-enabling studies, and Japan Patent No. 7677628 protects the platform through 2039. Reported tolerability showed no dose-limiting toxicities in the described preclinical work. Near-term plans include completing GLP toxicology and CMC packages, submitting an IND, and initiating a Phase 1/2 dose-escalation/expansion study with translational biomarkers and early efficacy readouts.
Hoth Therapeutics (NASDAQ: HOTH) on October 8, 2025 expanded its artificial intelligence initiative by entering an entitlement and renewal agreement for annual NVIDIA AI Enterprise Essentials licenses.
The licenses will support Hoth's GPU-powered infrastructure to enable advanced machine learning and neural network modeling for pharmaceutical research, including predictive pharmacology, toxicity modeling, multi-omic integration, clinical trial simulation, patient stratification, and real-time response monitoring. Management said the platform will be applied across development programs such as HT-001, HT-KIT, and oncology efforts to accelerate data-driven drug development and digital transformation.
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.
FAQ
What is the current stock price of Hoth Therapeutics (HOTH)?
What is the market cap of Hoth Therapeutics (HOTH)?
