HSTO - Histogen shares rise after FDA lifts clinical hold on early-stage HST-003 trial

Histogen (HSTO) shares jump more than 18% during premarket trading after announcing that the FDA has removed the clinical hold on its early-stage HST-003 trial.The company said that the health regulator confirmed that Histogen had satisfactorily addressed all clinical hold questions and can proceed with initiation of the planned trial of HST-003.The trial looks to evaluate the safety and efficacy of 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 expects to initiate the Phase 1/2 trial in the second quarter of 2021 by utilizing funding provided by the $2M grant from the Department of Defense.The company had announced that the FDA had sought additional questions regarding its Investigational New Drug (“IND”) application for the planned Phase 1/2 clinical trial for HST-003, in January.

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Histogen shares rise after FDA lifts clinical hold on early-stage HST-003 trial