HOTH

In a head-to-head preclinical comparison, HT-VA co-developed with the United States Veterans Administration GDNF demonstrated superior efficacy compared with semaglutide (the active ingredient in Wegovy®️ and Ozempic®️) across key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models NEW YORK, Feb. 10, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapies for unmet medical needs, today announced compelling preclinical data from its VA-backed study on glial cell-derived neurotrophic factor (GDNF) as a novel treatment for obesity and metabolic-associated steatotic liver disease (MASLD). In a head-to-head comparison, GDNF demonstrated superior efficacy over semaglutide (the active ingredient in Wegovy® and Ozempic®) in key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models. This breakthrough positions GDNF as a potential gamechanger in the $200 billion obesity market, offering a differentiated mechanism that could address limitations of current GLP-1 agonists like gastrointestinal side effects and muscle loss. With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms. Key Study Highlights: Superior Weight Management: In female mice on a high-fat Western diet, GDNF attenuated weight gain by 10-15%, leading to a plateau in the final weeks of treatment—unlike semaglutide, which showed no significant impact. Researchers noted that higher doses or longer durations could amplify GDNF's effects, suggesting even greater potential for sustained weight loss. Enhanced Glucose Metabolism: GDNF fully normalized fasting glucose and improved overall response to glucose challenges, outperforming semaglutide in females. Baseline improvements were also seen in males, indicating broad metabolic benefits. Liver and Adipose Health: GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing semaglutide's effects. This underscores GDNF's promise in resolving fatty liver disease, a common complication of obesity. Study Design: Conducted at the Srinivasan Lab with VA support, the 12-w...

NEW YORK, Sept. 2, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced combined positive findings from multiple preclinical programs evaluating its precision antisense candidate HT-KIT, including compelling anti-tumor efficacy, a clean safety profile, and new GLP-validated bioanalytical results that exceeded internationally recognized regulatory thresholds. Preclinical Efficacy & Safety Highlights Rapid Tumor Kill: HT-KIT triggered significant tumor cell death in preclinical models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis as early as 24 hours post-treatment, with statistically significant tumor shrinkage observed by day 8. Strong KIT Suppression: In vitro, HT-KIT achieved over 80% knockdown of KIT expression, the oncogenic driver in multiple aggressive cancers. Clean Safety Profile: Multi-dose in vivo studies confirmed no off-target toxicity across critical organs including liver, kidneys, spleen, bone marrow, and thymus. Dose-Dependent Biological Signal: A preclinical safety study demonstrated proportional liver engagement (increase from 1.11g to 1.32g at 3.0 mg/kg) with zero gross pathology at any organ site. GLP-Validated Bioanalytical Results The study, conducted by Altasciences Company, Inc. under OECD, FDA, and EMA GLP standards, demonstrated that HT-KIT meets or exceeds strict bioanalytical benchmarks: Regulatory-Grade Validation: All calibration curve, quality control, and dilution integrity requirements passed with high reproducibility. Superior Data Integrity: 90.5% of Incurred Sample Reanalysis (ISR) values fell within ±30%, well above the 66.7% regulatory minimum. Extended Stability: HT-KIT remained stable in serum for 37 days at -80°C, surpassing the validated 28-day stability period, with further studies ongoing. Flawless Compliance: No protocol or SOP deviations impacted study reliability. "These results combine a rare and powerful story — tumor kill within 24 hours, clean safety across all systems, and GLP-validated reproducibility beyond regulatory standards," said Robb Knie, CEO of Hoth Therapeutics. "We believe HT-KIT has the potential to transform outcomes in KIT-driven cancers, and these milestones accelerate our path toward IND submission and first-in-human trials." Next Steps Hoth expects to integrate this bioanalytical data into its forma...

Hoth Therapeutics' HT-001 Achieves 100% Response Rate in at least one endpoint in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities. Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at 3:30PM EST to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D., and Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients. Access/join the event through the following link: https://zoom.us/j/91353016981. Phase 2a Trial Highlights (CLEER-001) 100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement Over 65% reported reductions in pain and pruritus (itching) 0% required dose reduction or discontinuation of their EGFRI therapy. Topical therapy was well tolerated with no serious adverse events. NEW YORK, June 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing targeted therapies for rare and serious inflammatory conditions, today announced that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities. EGFR inhibitors, used widely to treat non-small cell lung cancer (NSCLC), pancreatic, breast, colorectal, and head and neck cancers, are associated with dermatologic side effects in up to 90% of patients, often resulting in painful rashes, pruritus, dryness, nail changes, and alopecia. These adverse events frequently force dose reductions or treatment discontinuation, limiting therapeutic efficacy and patient outcomes. "HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities," said Robb Knie, CEO of Hoth Therapeutics. "The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology." Phase 2a Trial Hi...

Hoth Therapeutics (HOTH) announced breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors. The results highlight HT-KIT’s ability to significantly reduce tumor burden in humanized mouse models, disrupt KIT signaling pathways, and induce tumor cell death. Key Findings from the preclinical study: Significant Reduction in KIT Expression – HT-KIT effectively reduced KIT receptor expression within 24 hours, with effects sustained for 72 hours. Induction of Tumor Cell Death – HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, while the lower dose led to delayed but substantial cell death at 72 hours. Decreased Tumor Cell Proliferation – HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, as confirmed by cell count reductions and decreased fluorescence intensity in proliferation assays. Marked Tumor Volume Reduction in GIST Mouse Models – In a humanized xenograft model, HT-KIT treatment led to a significant reduction in tumor growth, with differences becoming statistically significant by day 8 and increasing over time. Consistent Tumor Size Reduction – Excised tumors from HT-KIT-treated mice were smaller and lighter than those in the control group, reinforcing tumor volume measurements. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today’s best-performing stocks on TipRanks >> Read More on HOTH: Questions or Comments about the article? Write to [email protected] Hoth Therapeutics to submit Expanded Access application for HT-001 Hoth Therapeutics reports ‘promising’ results for HT-001 therapeutic candidate Hoth Therapeutics’ GDNF shows efficacy in obesity prevention and reversal Hoth Therapeutics announces collaboration with OnTargetx R&D Hoth Therapeutics regains compliance with Nasdaq listing rules

New Data Demonstrates Significant Reduction in Tumor Growth and KIT Expression in Preclinical GIST Models Induction of Tumor Cell Death – HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, while the lower dose led to delayed but substantial cell death at 72 hours. Decreased Tumor Cell Proliferation – HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, as confirmed by cell count reductions and decreased fluorescence intensity in proliferation assays. Marked Tumor Volume Reduction in GIST Mouse Models – In a humanized xenograft model, HT-KIT treatment (12.5 mg/kg IV every three days) led to a significant reduction in tumor growth, with differences becoming statistically significant by day 8 and increasing over time. Consistent Tumor Size Reduction – Excised tumors from HT-KIT-treated mice were smaller and lighter than those in the control group, reinforcing tumor volume measurements. NEW YORK, March 18, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST). The results highlight HT-KIT's ability to significantly reduce tumor burden in humanized mouse models, disrupt KIT signaling pathways, and induce tumor cell death. "These exciting findings mark a significant milestone in the development of HT-KIT as a potential new therapeutic for patients with GIST," said Robb Knie, CEO of Hoth Therapeutics. "By targeting KIT mutations, which are a major driver of GIST progression, HT-KIT has shown remarkable efficacy in preclinical models, demonstrating its potential as a transformative treatment option for this difficult-to-treat cancer." Key Findings from the Preclinical Study: Significant Reduction in KIT Expression – HT-KIT effectively reduced KIT receptor expression within 24 hours, with effects sustained for 72 hours. Induction of Tumor Cell Death – HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, while the lower dose led to delayed but substantial cell death at 72 hours. Decreased Tumor Cell Proliferation – HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, as confirmed by cell count reductions and decreased fluorescence intensity in proliferation ass...