NEW YORK - Hoth Therapeutics , Inc. (NASDAQ: NASDAQ:HOTH), a biopharmaceutical company, has announced the recent FDA Orphan Drug designation for its HT-KIT therapy, aimed at treating mast cell-derived cancers. In addition to this regulatory milestone, Hoth is advancing its preclinical development with a new study in collaboration with Altasciences.
The company has completed the bioanalytical method development, a crucial step in assessing the pharmacokinetics of HT-KIT in a humanized mouse model. The next phase involves Altasciences conducting a detailed analysis of mouse blood and plasma samples to determine the duration HT-KIT remains in the bloodstream after dosing.
Robb Knie, CEO of Hoth Therapeutics, expressed confidence in the ongoing partnership with Altasciences, known for its comprehensive preclinical and clinical pharmacology services. This collaboration is expected to be a final step before the company finalizes protocols for its Investigational New Drug (IND) application.
Hoth Therapeutics is primarily focused on developing treatments for various unmet medical needs, including skin toxicities associated with cancer therapy, mast-cell derived cancers, anaphylaxis, Alzheimer's Disease, and atopic dermatitis.
The Orphan Drug designation by the FDA is a significant achievement as it provides certain benefits, including market exclusivity upon approval, tax credits for qualified clinical testing, and waiver of FDA application fees.
While the company has expressed optimism about its product candidates and business strategies, it acknowledges that the outcomes are subject to substantial risks and uncertainties. These forward-looking statements are based on current expectations and projections about future events.
Investors are advised that this information is based on a press release statement and should consider the inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Hoth's progress in the development of HT-KIT reflects its commitment to addressing the challenges faced by patients with mast cell-derived cancers.
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