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

Published 29/12/2022, 14:08
Updated 29/12/2022, 15:10
© Reuters.  FDA Signs Off Hoth Therapeutics' Trial Application For HT-001 For Skin Cancers

Benzinga -

  • 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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