HSTO - Histogen announces FDA clinical hold of planned study for HST-003

Histogen (HSTO) has lost 17.8% in value in postmarket trading after the company announced that the FDA has sought additional questions regarding its Investigational New Drug (“IND”) application for the planned Phase 1/2 clinical trial for HST-003.The trial intended to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.The FDA’s verbal response has indicated that the clinical hold is due to pending CMC information required to complete their review, and a written notice in this regard is expected by February 12, the company said in an announcement.The company announced the filing of the IND application for the trial in mid-December.

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Histogen announces FDA clinical hold of planned study for HST-003