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) reported female-specific preclinical data showing its GDNF candidate HT-VA restored serum cholesterol to control-diet levels and maintained lower triglycerides versus semaglutide in western diet–fed female mice. The treatment preserved hepatic autophagy and showed no activation of lipogenesis or pAKT signaling.
Study used female mice (8–10 per group) with eight weeks of diet and four weeks of treatment; results support continued development for MASLD and metabolic dysfunction associated with obesity.
Hoth Therapeutics (NASDAQ: HOTH) deployed the OpenAI API to support IND-enabling development of HT-KIT, its orphan-designated therapy for rare KIT-driven cancers. Key preclinical findings include >80% KIT mRNA/protein suppression, statistically significant tumor-volume reduction by Day 8, and no dose-limiting toxicities reported.
GLP-validated bioanalytical methods are complete and HT-KIT is advancing toward IND submission and Phase 1 clinical evaluation.
Hoth Therapeutics (NASDAQ: HOTH) announced expansion of its CLEER-001 Phase 2a trial with a new enrolling site, Regis Clinical Research in Miami, on Feb 24, 2026.
Interim data show 100% of open-label cohort met the primary ARIGA ≤1 endpoint by week six, 0 dose reductions, >65% meaningful pain/itch relief, and 0 dose-limiting toxicities; the company said the new site will speed enrollment and data collection.
Hoth Therapeutics (NASDAQ: HOTH) received a Notice of Allowance from the USPTO on February 12, 2026, for a patent titled "Exon Skipping of FC-Epsilon-RI-Beta and MS4A6A in the Treatment of Allergic Diseases."
The allowed claims cover a dual-mechanism approach—exon skipping in the high-affinity IgE receptor pathway and modulation of MS4A6A—positioning Hoth to expand its immunology IP, pursue partnerships, and strengthen long-term defensibility in allergic and inflammatory disease markets.
Hoth Therapeutics (NASDAQ: HOTH) reported preclinical VA-backed results showing its HT-VA GDNF outperformed semaglutide in a 12-week CF-1 mouse obesity model. Key findings: female weight attenuation 10–15%, fasting glucose normalized, and liver weight reduced 20–30%. Hoth targets IND-enabling studies toward clinical trials in 2027.
Further analyses (liver pathology, lipids, gene/protein expression) are planned to clarify mechanisms.
Hoth Therapeutics (NASDAQ: HOTH) clarified market rumors about cryptocurrency exposure on February 5, 2026. The company said it holds no cryptocurrency assets and that its maximum exposure over the last year "never reached more than $350,000 USD."
Hoth also reaffirmed ongoing work on the HT-001 clinical trial and progress toward additional oncology and obesity studies.
Hoth Therapeutics (NASDAQ: HOTH) reported positive interim results from the open-label PK cohort of CLEER-001 evaluating HT-001 in cancer patients receiving EGFR inhibitors on Jan 22, 2026. Mean ARIGA scores improved from 1.67 to 0.83 by Week 6 (~50% reduction), with 100% of evaluable patients reaching low-severity disease (ARIGA ≤1). Investigator-assessed CTCAE improved from 2.0 to 1.33 (~34% improvement) and patient-reported pruritus fell from 4.22 to 2.67 (~37% reduction). HT-001 was well tolerated with no unexpected safety signals, supporting the selected dosing and continued development.
Hoth Therapeutics (NASDAQ: HOTH) announced that the China National Intellectual Property Administration approved a key patent for the company's HT-KIT cancer program on January 21, 2026. The patent, originating from a PCT application, covers systems and methods for targeting KIT signaling to induce apoptosis and expands Hoth's intellectual property protection in China, a major oncology market. Hoth said this issuance strengthens its global IP estate for HT-KIT, may enhance future partnering and licensing opportunities, and supports continued development and strategic milestones for the program.
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.