Fate Gets FDA IND Clearance For FT839 To Initiate Phase 1/2 Trial In Autoimmune Diseases

Fate Therapeutics said the FDA cleared its Investigational New Drug (IND) application for FT839, an off-the-shelf CAR T-cell candidate targeting CD19 and CD38. The regulatory clearance de-risks the company’s path to initiating clinical development, which should be supportive for sentiment and expectations around future trial readouts.

Analysis

Fate Therapeutics said the FDA cleared its Investigational New Drug (IND) application for FT839, an off-the-shelf CAR T-cell candidate targeting CD19 and CD38. The regulatory clearance de-risks the company’s path to initiating clinical development, which should be supportive for sentiment and expectations around future trial readouts.