Iryna Drozd
Hoth Therapeutics (NASDAQ:HOTH) stock jumped 6% in early trading after the company said it received positive feedback from the FDA on the proposed development plan for its oncology drug candidate HT-KIT.
Hoth said in a statement that it met with the FDA ahead of its Investigational Drug Application for the drug to discuss the suitability of 505(b)(1) pathway for the product, the adequacy of the referenced nonclinical information for the application, the proposed development plan to support the IND and any filing issues the FDA might have with the product.
The biotech company said that based on the FDA’s feedback, it plans to proceed with its pre-IND activities as planned. Hoth is developing the drug for the treatment of AdvSM, or advanced systemic mastocytosis.
The product has already received orphan drug designation from the agency for the treatment of mastocytosis.