FDA Clears Histogen's HST-003 Early-Stage Study For Knee Cartilage Regeneration

The FDA has lifted the clinical hold on Histogen Inc's HSTO HST-003 Investigational New Drug application and said it could initiate Phase 1/2 trial.

• The planned study of HST-003 evaluates 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.
• The trial will start in the second quarter of 2021, utilizing the $2M grant from the Department of Defense.
• In January this year, the agency has verbally notified the company that it has additional questions about the HST-003 IND package.
• Price Action: HSTO shares increased 11.8% at $1.51 in premarket trading on the last check Monday.