FDA Signs Off Hoth Therapeutics' Trial Application For HT-001 For Skin Cancers

• The FDA has accepted the Investigational New Drug (IND) application for Hoth Therapeutics Inc's (NASDAQ: HOTH) HT-001 therapeutic for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy.

• EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.

• "With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients," said Robb Knie, CEO of Hoth Therapeutics.

• The company expects to begin the Phase 2a trial in Q1 of 2023.

• In October, Hoth Therapeutics announced Phase 1b trial data for BioLexa in adult patients with mild-to-moderate atopic dermatitis showing an improvement in disease severity.

• Price Action: HOTH shares are up 54.50% at $6.80 during the premarket session on the last check Thursday.

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