HSTO - Histogen falls after FDA clinical hold on HST-003 study in knee tissue regeneration

Histogen (HSTO) drops 22% after hours in reaction to FDA's clinical hold on the company's planned Phase 1/2 trial to evaluate the safety and efficacy for HST-003 for knee cartilage regeneration.The agency has verbally notified the company that it has additional questions about the company’s Investigational New Drug application package for HST-003, a human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.Histogen has not yet received the written notice of its clinical hold, which the FDA expects to provide to the company by February 12. Based upon the verbal communication, they indicated that the clinical hold is due to pending Chemistry, Manufacturing, and Controls information.

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Histogen falls after FDA clinical hold on HST-003 study in knee tissue regeneration