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Recent press releases and 8-K filings for HOTH.
Hoth Therapeutics Announces Positive Interim Results for HT-001 Clinical Trial
HOTH
Product Launch
New Projects/Investments
- Hoth Therapeutics (NASDAQ: HOTH) announced positive interim results from its CLEER-001 clinical trial for HT-001, a proprietary topical therapy for cancer patients receiving EGFR inhibitor therapy.
- In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, with an approximate 50% reduction in investigator-assessed disease severity (ARIGA scores) from baseline, and all evaluable patients reached low-severity disease.
- The trial also demonstrated a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, with HT-001 being well tolerated and showing no unexpected safety signals.
Jan 22, 2026, 1:13 PM
Hoth Therapeutics Secures Patent for HT-KIT Cancer Program in China
HOTH
New Projects/Investments
Legal Proceedings
- Hoth Therapeutics announced that the China National Intellectual Property Administration has approved a key patent covering the Company's HT-KIT cancer program.
- The patent provides important intellectual property protection in China, one of the world's largest oncology markets, strengthening Hoth's global IP estate for HT-KIT.
- HT-KIT is a novel therapeutic approach designed to induce apoptosis in disease-driving cells by targeting KIT signaling pathways, aiming to selectively impact cancer cells.
- This patent issuance represents a significant validation of the HT-KIT platform, enhancing its long-term strategic and commercial value.
Jan 21, 2026, 1:13 PM
Hoth Therapeutics achieves positive EU regulatory conclusion for HT-001 oncology trial
HOTH
New Projects/Investments
- Hoth Therapeutics (HOTH) has achieved a positive EU regulatory conclusion for Part I of its HT-001 clinical program, which targets cancer patients undergoing EGFR inhibitor therapies.
- This determination confirms the scientific and regulatory acceptability of the trial design and investigational products, positioning the company to activate clinical trial sites and initiate the study across multiple European countries.
- Country-specific Part II regulatory decisions in Hungary, Spain, and Poland are anticipated by January 19, 2026, facilitating rapid, multi-national clinical execution.
- The HT-001 program is designed to address EGFRI-induced dermatologic toxicities, a significant complication for oncology patients.
Jan 15, 2026, 1:17 PM
Hoth Therapeutics Highlights FDA Orphan Drug Designation and Strong Preclinical Data for HT-KIT
HOTH
New Projects/Investments
- Hoth Therapeutics announced that its drug candidate, HT-KIT, received FDA Orphan Drug Designation.
- Preclinical data for HT-KIT demonstrated over 80% suppression of KIT expression and significant tumor-volume reduction by Day 8 in systemic mastocytosis and GIST models.
- The company has completed GLP-validated bioanalytical methods to support IND-enabling studies and secured a Japan Patent protecting the platform through 2039, with plans to submit an Investigational New Drug (IND) application and initiate a Phase 1/2 study.
Oct 21, 2025, 12:23 PM
Hoth Therapeutics, Inc. Details Clinical and Preclinical Pipeline Progress
HOTH
New Projects/Investments
Guidance Update
- Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company, provided an update on its operations and performance, highlighting a diverse pipeline of next-generation therapeutics.
- The company's lead clinical program, HT-001 Topical Gel, is in a Phase 2a study for EGFR Inhibitor Skin Toxicity, with a submission for clinical trial expansion in the EU planned for Q3 2025.
- Another key clinical program, HT-KIT Injection for Mast-Cell Derived Cancers, is undergoing IND-Enabling Animal Toxicology Studies, targeting an IND submission in Q4 2026.
- Preclinical programs include HT-ALZ for Alzheimer's Disease and HT-VA for obesity and asthma, with preclinical studies for HT-VA initiated in Q3 2025.
- As of October 14, 2025, the company reported 15.4 million shares outstanding and confirmed sufficient cash on hand to fund its current clinical and preclinical programs.
Oct 17, 2025, 8:15 PM
Hoth Therapeutics Expands HT-001 Patent Portfolio for New Dermatological Indications
HOTH
New Projects/Investments
- Hoth Therapeutics has expanded its intellectual property portfolio for its lead topical therapeutic candidate, HT-001, by filing multiple U.S. Provisional Patent Applications.
- The new patent filings cover novel dermatological indications, including Drug-Induced Hypersensitivity Syndrome, Radiotherapy-Induced Rash, and dermatological conditions associated with MENIN Inhibitor Therapy.
- This expansion aims to broaden the commercial and clinical potential of HT-001, positioning the company to address significant unmet needs in oncology supportive care.
- HT-001 is designed to improve the tolerability of cancer therapies by mitigating dermatological side effects, potentially enabling patients to remain on therapy longer.
Sep 24, 2025, 12:13 PM
Hoth Therapeutics Issues Shareholder Update on Clinical Programs and Treasury Strategy
HOTH
New Projects/Investments
Guidance Update
- Hoth Therapeutics is advancing its clinical programs, with HT-001 expanding globally through a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its Phase II trial, and HT-KIT successfully completing its Good Laboratory Practice (GLP) bioanalytical phase.
- The company is also progressing its VA obesity program in partnership with the U.S. Department of Veterans Affairs.
- Hoth's Board of Directors approved an expansion of its treasury reserve strategy to include Ethereum and Solana, alongside Bitcoin, allowing for potential purchases of up to $1 million in these digital assets.
- The company has integrated AI by adopting Lantern Pharma's PredictBBB.ai platform to enhance data-driven decision-making across its programs.
Sep 16, 2025, 12:14 PM
Hoth Therapeutics' HT-KIT Surpasses Preclinical Milestones
HOTH
New Projects/Investments
- Hoth Therapeutics' precision antisense candidate, HT-KIT, has shown positive findings from multiple preclinical programs, demonstrating compelling anti-tumor efficacy and a clean safety profile.
- Preclinical models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis showed significant tumor cell death within 24 hours of HT-KIT treatment, with statistically significant tumor shrinkage observed by day 8.
- In vitro, HT-KIT achieved over 80% knockdown of KIT expression, and multi-dose in vivo studies confirmed no off-target toxicity across critical organs.
- GLP-validated bioanalytical results for HT-KIT, conducted by Altasciences Company, Inc., met or exceeded strict bioanalytical benchmarks, including 90.5% of Incurred Sample Reanalysis (ISR) values falling within ±30%, which is above the 66.7% regulatory minimum.
- Hoth Therapeutics plans to integrate this bioanalytical data into its formal GLP toxicology package and is preparing for an IND submission and first-in-human trials for HT-KIT.
Sep 2, 2025, 12:16 PM
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