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) received Institutional Review Board approvals from Montefiore Medical Center and Dana-Farber Cancer Institute to proceed with a First-in-Human (FIH) Phase 2a dose-ranging clinical trial of HT-001 to treat skin toxicities caused by EGFR inhibitors. The study will evaluate efficacy, safety, and tolerability of topical HT-001. The company reported ending the prior quarter with over $9 million in cash and stated it had no plans for further capital raises in 2024. More trial information is available at clinicaltrials.gov.
Hoth Therapeutics (NASDAQ: HOTH) received a positive regulatory conclusion under the EU Clinical Trials Information System (CTIS) for Part I of its HT-001 oncology program targeting EGFR inhibitor–related dermatologic toxicities. The CTIS determination confirms scientific and regulatory acceptability of the trial design and investigational products and gives a clear line of sight to site activation and enrollment across multiple European countries. Country-specific Part II decisions in Hungary, Spain, and Poland are expected by January 19, 2026. Hoth expects near-term site activation, patient enrollment, and advancement into active clinical execution for this supportive-care oncology study.
Hoth Therapeutics (NASDAQ: HOTH) announced on January 2, 2026 the filing of two U.S. provisional patent applications to expand its intellectual property into an oncology-focused dermatology platform.
The filings claim use of HT-001 to treat treatment-induced skin toxicities from radiation therapy and from emerging targeted cancer therapies (including second- and third-generation menin inhibitors), securing priority rights across multiple oncology modalities and formulations.
The company describes HT-001 as a receptor antagonist targeting neurogenic and inflammatory pathways and says the provisional filings support further preclinical work, formulation optimization, and potential future U.S. and international patent protection.
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.
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