HSTO - Histogen's HST-002 designated as drug-biologic-device combination product

Histogen's ([[HSTO]] +0.7%) HST-002 is now designated as drug-biologic-device combination product by Office of Combination Products, a division of the FDA. In April of 2020, Histogen had submitted an Investigational Device Exemption application for HST-002 based upon its primary mechanism of action and historical regulatory precedence for approved dermal fillers.HST-003 program for regeneration of cartilage in the knee and anticipate filing an IND in Q4 2020.“We remain on track to announce top line data results in the fourth quarter of this year for our HST-001 phase 1b/2a trial for androgenic alopecia in men,” said Richard W. Pascoe, President and CEO.

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Histogen's HST-002 designated as drug-biologic-device combination product