Hoth Therapeutics is progressing HT-KIT towards clinical evaluation, aiming to submit an investigational new drug application to the FDA in early 2026. An investigational new drug application is a request for FDA authorization to administer an investigational drug to patients. This step is crucial before administering any new drug not yet approved through a new drug application or biologics license application. The potential of HT-KIT in treating rare KIT-driven cancers is promising, highlighting a significant advancement in therapeutic options for these specific cancer types.
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