Hoth Therapeutics Inc. (NASDAQ:HOTH) Stock Turns Volatile After the FDA News

Shares of Hoth Therapeutics Inc. (NASDAQ:HOTH) have been witnessing very volatile over the past few sessions.

Trading Data

On Friday, HOTH stock slumped 23.43% to $0.6101 with more than 4.05 million shares, compared to its average volume of 5.58 million shares. The stock moved within a range of $0.5910 – 0.6474 after opening trade at $0.6445.

Orphan Drug Designation Granted to Cancer Therapeutic HT-KIT for Treating Mastocytosis, Being Developed by Hoth Therapeutics

Hoth Therapeutics, Inc. (NASDAQ:HOTH) announced on March 11, 2022 that the U.S. Food and Drug Administration (FDA) designated HT-KIT, which is a new molecular entity, has now been given the status of an “orphan drug” for the treatment of the rare blood disorder mastocytosis.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting. Preclinical studies have shown promising results – HT-KIT induces apoptosis of neoplastic mast cells and minimizes metastasis associated with aggressive mastocytosis (caused due to excess number of mast cells, a type of white blood cells that gather in the body’s tissues). Clinical formulation development of HT-KIT is presently underway.

The FDA grants “orphan drug” designation to investigational therapies that addresses rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This status benefits drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

The HT-KIT is a new mode of treatment for aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN), acute myeloid leukemia, gastrointestinal stromal tumors, and other cKIT-driven diseases. Stefanie Johns, Ph.D., Chief Scientific Officer of Hoth stated that this designation is a significant milestone for paving the way of drug development when it comes to patients who require new therapies for treatment of mastocytosis.

Technical Data

HOTH stock is trading below the 50-Day and 200-Day Moving averages of $0.68 and $1.08 respectively. The stock is trading in oversold zone with the RSI at 49.