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) 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.
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.