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) has announced breakthrough preclinical results for HT-KIT, their novel targeted therapy for gastrointestinal stromal tumors (GIST). The study demonstrated significant efficacy in several key areas:
- Tumor cell death occurred within 24 hours of treatment
- Reduced KIT receptor expression was sustained for 72 hours
- Decreased tumor cell proliferation in GIST-T1 cells
- Significant tumor growth reduction in humanized xenograft models by day 8
- Smaller and lighter tumors in HT-KIT-treated mice compared to control group
HT-KIT targets KIT mutations, which drive GIST progression, potentially offering a new treatment option for patients who develop resistance to current therapies. The company plans to conduct additional preclinical studies before initiating regulatory discussions for first-in-human trials.
Hoth Therapeutics (NASDAQ: HOTH) has announced plans to submit an Expanded Access application for its therapeutic candidate HT-001. The drug is being developed to treat dermatological side effects in cancer patients using EGFR inhibitor treatments.
The company aims to make HT-001 available through the Expanded Access Program (EAP), also known as 'compassionate use', which allows patients with serious conditions to access investigational treatments outside traditional clinical trials. This initiative comes following positive progress in ongoing clinical studies.
The EAP submission represents a strategic move to provide treatment access while gathering additional safety and efficacy data for HT-001, specifically targeting patients who lack comparable treatment options.
Hoth Therapeutics (NASDAQ: HOTH) has announced positive results for HT-001, their topical neurokinin 1 receptor antagonist, in treating EGFR inhibitor-associated skin conditions. A case study demonstrated remarkable efficacy where a 59-year-old metastatic breast cancer patient experienced complete resolution of skin lesions after one week of twice-daily HT-001 2% cream application, with no recurrence in the following three weeks.
The therapy works by blocking the pro-inflammatory SP-NK1R pathway. The company is currently conducting a Phase 2A clinical trial to evaluate HT-001's efficacy and safety in a broader patient population with varying severities of EGFR inhibitor-induced skin reactions.
These findings will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting from March 7-11, 2025, positioning HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.
Hoth Therapeutics (NASDAQ: HOTH) has announced promising preclinical findings for Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a potential obesity treatment. The study, using GDNF-transgenic models, demonstrated significant results in:
- Reduced body weight and fat deposition despite high-fat diet consumption
- Increased basal metabolic rate and energy expenditure
- Suppression of fat storage genes while promoting fat oxidation
- Enhanced glucose tolerance and lower serum leptin levels
- Prevention of hepatic steatosis (liver fat accumulation)
The research, conducted in partnership with the Department of Veterans Affairs, suggests GDNF could revolutionize obesity treatment by enhancing natural metabolic processes rather than restricting food intake. Hoth is exploring multiple development pathways, including recombinant protein delivery, gene therapy, and small-molecule mimetics.
Hoth Therapeutics (NASDAQ: HOTH) has announced a partnership with OnTargetx R&D Inc. to advance research for its cancer-fighting therapeutic, HT-KIT. The collaboration includes an immunohistochemistry study conducted with Charles River Laboratories Montreal ULC, marking a significant step in HT-KIT's preclinical development.
The study focuses on developing and optimizing staining methods for c-Kit markers, which are important targets in HT-KIT's therapeutic mechanism. It includes processing and qualitative evaluation of tissue samples by a board-certified pathologist to determine marker presence, along with comprehensive reporting to support HT-KIT's development.
HT-KIT is a preclinical therapeutic candidate targeting c-Kit, a receptor tyrosine kinase involved in various cancers, representing a potential advancement in precision oncology therapies.
Hoth Therapeutics (NASDAQ: HOTH) has successfully regained compliance with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2). The company received official notification from Nasdaq on January 23, 2025, confirming compliance after maintaining a closing bid price at or above $1.00 per share for 10 consecutive business days, from January 7 to January 22, 2025.
CEO Robb Knie emphasized this achievement as a reflection of the company's commitment to creating long-term shareholder value and maintaining high corporate governance standards. The biopharmaceutical company confirms its continued focus on advancing its pipeline and delivering healthcare solutions.
Hoth Therapeutics (NASDAQ: HOTH) has announced the acquisition and expansion of patent applications to strengthen its intellectual property portfolio. The new patents will be utilized to explore additional indications for the company's HT-001 Cancer Therapeutic.
The company positions these acquisitions as part of its strategy to develop innovative treatments for unmet medical needs, focusing on enhancing therapeutic efficacy and expanding applications across various disease areas. CEO Robb Knie emphasized that these provisional patent applications reinforce Hoth's proprietary approaches and align with their mission to deliver breakthrough therapies.
Hoth Therapeutics (NASDAQ: HOTH) has announced its participation in the upcoming Sequire Investor Summit, scheduled for January 21-23, 2025. The company's Chief Executive Officer, Robb Knie, will be attending the event, representing the biopharmaceutical company at this significant investor conference.
Hoth Therapeutics (NASDAQ: HOTH) has addressed market rumors and shareholder inquiries by confirming it has no plans for public or private offerings. The company highlighted its strong financial position with over $10 million in cash and no debt, emphasizing its ability to execute strategic initiatives without immediate need for additional financing.
The company also reported progress in its clinical development, announcing that all trial sites for HT-001, its lead therapeutic candidate for treating rash and skin disorders associated with cancer therapy, are now active and enrolling participants. CEO Robb Knie emphasized the company's focus on creating long-term value and advancing clinical programs, stating that the activation of all trial sites represents a significant milestone in HT-001's development.
Hoth Therapeutics (NASDAQ: HOTH) has announced promising interim results from its Phase 2a clinical trial of HT-001, a treatment targeting skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients. The CLEER-001 trial demonstrated 100% success rate in achieving the primary efficacy endpoint, with all patients showing significant skin toxicity improvement within six weeks.
Key outcomes include 66% of patients reporting reduced pain and itching scores, and notably, all patients maintained their full EGFRi cancer treatment dosage without reductions. The trial utilizes the proprietary Acneiform Rash Investigator Global Assessment Scale (ARIGA) for precise measurement of improvements. Importantly, no treatment-related adverse effects were reported, confirming HT-001's safety profile.