HOTH - FDA grants Hoth Therapeutics Pre-IND meeting for HT-001 shares up 15%

Hoth Therapeutics' (HOTH) jumps 15% premarket in reaction to the announcement that its Pre-IND meeting requested on Dec. 22 for HT-001 with the FDA has been granted to receive written responses that are targeted for delivery on February 22, 2021. The Pre-IND meeting topics include the acceptability of the drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.The proposed clinical trial designs for the first clinical studies (phase 2) in the HT-001 program are also included.Recently, HOTH inked a deal with Charles River Laboratories to initiate preclinical studies of HT-001.

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FDA grants Hoth Therapeutics Pre-IND meeting for HT-001, shares up 15%