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NEW YORK - Hoth Therapeutics, Inc. (NASDAQ:HOTH), a microcap biotech company with a market capitalization of $16.25 million, reported that its investigational drug HT-001 met at least one primary endpoint in all patients enrolled in its ongoing Phase 2a clinical trial for treating skin toxicities caused by epidermal growth factor receptor inhibitors (EGFRIs). According to InvestingPro data, the company’s stock has shown strong momentum, gaining over 55% in the past six months.
According to the company’s press release, the open-label cohort in the CLEER-001 trial showed 100% of patients achieved at least one primary endpoint of clinical dermatologic improvement. Over 65% of patients reported reductions in pain and itching, and none required dose reduction or discontinuation of their cancer treatment. The company maintains a strong liquidity position with a current ratio of 15.08, indicating robust ability to fund its clinical programs. InvestingPro analysis reveals several additional financial health indicators available to subscribers.
EGFRI medications, commonly used to treat several cancer types including non-small cell lung cancer and colorectal cancer, cause skin-related side effects in up to 90% of patients. These side effects often lead to treatment modifications that can limit therapeutic effectiveness.
HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist. The treatment was well-tolerated with no serious adverse events reported in the trial.
"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, in the statement.
The company is developing HT-001 under the FDA’s 505(b)(2) regulatory pathway, which allows use of existing safety data to accelerate development. Hoth Therapeutics plans to host a Key Opinion Leader event Tuesday featuring dermatology specialists to discuss the interim results.
The biopharmaceutical company focuses on developing treatments for rare and serious inflammatory conditions, skin disorders, cancer, and neurological conditions. Analyst consensus suggests significant upside potential for the stock, with price targets ranging from $4 to $5 per share. For deeper insights into Hoth’s financial health and growth prospects, including exclusive ProTips and detailed metrics, visit InvestingPro.
In other recent news, Hoth Therapeutics announced that it has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the exchange. The company also reported positive preclinical safety data for its cancer treatment candidate HT-KIT, noting dose-responsive effects without observable toxicity in animal studies. Additionally, Hoth Therapeutics secured a Japanese patent for its HT-KIT platform technology targeting mast cell diseases, which provides exclusive protection until 2039. The company is seeking strategic global partners, particularly in Asia, for co-development and commercialization opportunities. In another development, Hoth Therapeutics is advancing its investigational drug HT-001 for cancer patients experiencing skin toxicities from EGFR inhibitor therapies. The company has engaged Premier Research to support an Expanded Access Program for HT-001, aiming to provide compassionate access to patients outside traditional clinical trials. Furthermore, Hoth Therapeutics is set to present interim clinical trial results for HT-001 at a Key Opinion Leader event, highlighting its potential as a supportive care drug. The company has also received a USPTO Filing Receipt for a new patent application for HT-001’s formulation, strengthening its intellectual property strategy.
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