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New Alert: Hoth Therapeutics, Inc. (NASDAQ: HOTH)
HOTH is our brand new NASDAQ alert.
The company has been building momentum over the past few days.
This could be just the start of a bigger rally higher.
Moreover, it has a history of large moves in a short period of time.
With a chart setup pointing to a breakout opportunity.
In addition, HOTH has announced multiple accomplishments recently that could continue to be big growth catalysts.
HOTH is a NASDAQ listed “clinical-stage biopharmaceutical company”.
HOTH is “dedicated to advancing innovative, first-in-class therapies designed to improve patient quality of life”.
With a “patient-centric approach and global development strategy, Hoth is actively pursuing breakthroughs in oncology supportive care and beyond”.
HOTH is “a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing”.
In addition, the company collaborates and partners with “a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options”.
HOTH has in primary development five key assets:
“HT-001 Topical Gel”
“Addresses Unmet Need: No current approved product on the market that specifically treats EGFR inhibitor cutaneous toxicities, which occur in up to 90% of patients undergoing EFGR inhibitor therapy.”
“HT-KIT Injection”
“Addresses Unmet Need: KIT D816V mutation found in >80% of adult systemic mastocytosis cases results in confirmational changes that make some tyrosine kinase inhibitor drugs ineffective.”
“cKIT is also implicated in gastrointestinal stromal tumors, acute myeloid leukemia, and other rare cancers”
“HT-ALZ Oral Soluble Film”
“Addresses Unmet Need: There are currently no drugs approved that are considered disease modifying and demonstrate cognitive improvement. Preclinical data with HT-ALZ indicates HT-ALZ may provide reduced neuroinflammation and significant improvements in cognitive functions such as memory and learning.”
“BioLexa Lotion”
“Addresses Unmet Need: Non-corticosteroid treatment targeted for treatment of both pediatric and adult mild to moderate AD populations”
“HT-004”
“Addresses Unmet Need: New class of drug for maintenance treatment of asthma with potential for a better safety profile”
In July, the company announced:
“Hoth Therapeutics Signs VA Research Deal to Advance GDNF as Breakthrough Therapy for Obesity and Fatty Liver - Side-by-Side Study vs. Semaglutide Begins”
As the company further explains:
HOTH “announced a CRADA (Cooperative Research and Development Agreement) with the U.S. Department of Veterans Affairs and Foundation for Atlanta Veterans Education and Research (FAVER) to evaluate GDNF (glial cell-derived neurotrophic factor) as a novel metabolic therapy targeting obesity and hepatic steatosis (fatty liver disease).”
Importantly:
“This CRADA marks the first pharmacologic test of GDNF in human liver-engrafted mice — setting the stage for potential first-in-class metabolic applications beyond CNS indications.”
Here are some of the comments from this press release:
"This landmark agreement allows a real-world, controlled comparison of GDNF's metabolic effects alongside semaglutide — the current gold standard," said Robb Knie, CEO of Hoth Therapeutics. "We are proud to support the VA's efforts in exploring bold new solutions for obesity and liver disease."
In addition, the company also announced:
“Hoth Therapeutics Announces Engagement with ICON and Expansion of Phase II Clinical Trial for HT-001 in Europe”
“The Company plans to extend its Phase II trial of HT-001 in Cancer Patients with skin toxicities in European Union (EU) Countries”
Here are some of the comments from this press release:
"We are delighted with the addition of clinical sites in the EU and for a strong partnership with ICON. ICON was selected based on their previous clinical trial management experience and their interest in novel therapies," said Robb Knie, CEO of Hoth Therapeutics. "Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial."
In addition, HOTH has announced multiple accomplishments recently.
In September, the company announced:
“Hoth Therapeutics' Cancer Therapeutic HT-KIT Surpasses Preclinical Milestones With Potent Anti-Tumor Activity and GLP-Validated Bioanalytical Results, Exceeding Regulatory Standards”
Here are some of the comments from this press release:
"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."
In addition, the company also announced:
“Hoth Therapeutics Taps Lantern Pharma's PredictBBB.ai Platform -- Breakthrough AI With 94% Accuracy Driving Next-Gen Drug Development”
“NEW YORK, Sept. 4, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced that it is leveraging Lantern Pharma's breakthrough PredictBBB.ai™ platform, a next-generation artificial intelligence (AI) tool with 94% accuracy in predicting blood-brain barrier permeability. This adoption positions Hoth at the forefront of AI-driven drug development, reinforcing its commitment to cutting-edge innovation and accelerated therapeutic discovery.”
As the company further explains:
“PredictBBB.ai, part of Lantern's RADR® AI platform, is a game-changing technology designed to eliminate one of the most significant bottlenecks in drug development: determining whether a candidate can cross the blood-brain barrier. By deploying this AI-driven solution, Hoth expects to streamline candidate selection, reduce development risk, and accelerate timelines toward transformative therapies.”
Importantly, here’s the “Strategic Impact for Hoth Therapeutics”:
“The ability to cross the blood-brain barrier is a critical success factor for drug candidates. With PredictBBB.ai, Hoth gains access to AI-powered insights that increase precision and reduce uncertainty, potentially creating faster regulatory pathways and higher value inflection points for its pipeline.”
Here are some of the company’s comments:
"Hoth is committed to deploying disruptive technologies like AI to enhance precision in drug development," said Robb Knie, Chief Executive Officer Hoth Therapeutics. "Our integration of Lantern's PredictBBB.ai tool aligns with our mission to deliver life-changing therapies while driving efficiency, reducing costs, and unlocking new opportunities for patients and shareholders alike."
On Wednesday, the company also announced:
“Hoth Therapeutics Secures Key European Regulatory Milestone with EMA Submission for Phase II Trial of HT-001 in Cancer Patients Suffering from EGFRi-Induced Skin Toxicities”
“NEW YORK, Sept. 10, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi).”
“The submission marks a major regulatory inflection point for Hoth, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments. Pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple U.S. sites.”
“CEO Commentary”:
"We are very pleased with the timely CTA submission to the EMA, a pivotal step in advancing our international development of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Skin toxicities from EGFRi therapies remain an urgent, unmet medical need, and with no FDA or EMA-approved treatment available, advancing HT-001 in Europe represents a powerful opportunity to improve patient quality of life and drive meaningful value creation for shareholders."
“Next Catalysts on Horizon”:
“EMA Decision Expected in Coming Months covering initial sites across three EU countries.”
“Broader EU Expansion underway, with additional sites targeted to accelerate patient enrollment.”
“U.S. Phase 2a Trial Progressing – evaluating efficacy, safety, and tolerability of HT-001.”
HOTH could be positioned for increased growth potential.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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