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Hoth Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to HT-KIT to treat mastocytosis. Mastocytosis is a rare condition caused by an abnormal accumulation and activation of mast cells in the skin, bone marrow, and internal organs. HT-KIT is a new molecular entity (NME) being developed to treat mast cell derived cancers and anaphylaxis. The drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, which is required for the proliferation, survival, and differentiation of bone marrow-derived hematopoietic stem cells. HT-KIT yields a new method of action in tackling serious, cKIT-driven diseases and conditions such as aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN). Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on finding, investigating, and developing early-stage therapeutics that will change the way that diseases are managed and treated.

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