Shares of Hoth Therapeutics (NASDAQ:HOTH) surged by 6% during early trading following the company’s announcement of receiving affirmative feedback from the FDA regarding the proposed development plan for its oncology drug candidate, HT-KIT.
In an official statement, Hoth revealed that it held discussions with the FDA before filing its Investigational Drug Application for the drug. The meeting aimed to assess the suitability of the 505(b)(1) pathway for the product, the sufficiency of referenced nonclinical information for the application, the proposed development plan to support the IND, and any potential filing issues the FDA might raise concerning the product.
The biotech company outlined its intention to proceed with pre-IND activities as scheduled, leveraging the insight gained from the FDA’s feedback. Hoth is dedicated to developing the drug for treating AdvSM, or advanced systemic mastocytosis, a promising medical pursuit.
Notably, the product has secured orphan drug designation from the FDA for its efficacy in treating mastocytosis.