Hoth Therapeutics: FDA Grants Pre-IND Meeting For HT-KIT; Stock Surges

(RTTNews) - Hoth Therapeutics, Inc. (HOTH) announced the Pre-IND meeting previously requested for HT-KIT with the FDA has been granted to receive written responses only from the FDA that are targeted for delivery on November 7, 2023. HT-KIT is an antisense oligonucleotide that already has Orphan Drug Designation from the FDA.

Robb Knie, CEO of Hoth Therapeutics, said: "Receiving feedback from the FDA in November positions us well to achieve our planned IND-enabling development activities on time with the eventual goal of initiating the first HT-KIT clinical trial in patients."

The company said the pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.

Shares of Hoth Therapeutics are up 6% in pre-market trade on Monday.

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