Satellite Biosciences received FDA IND clearance for SB-101, an investigational therapy for urea cycle disorders, with a Phase I/II trial planned in infants with severe, early-onset urea cycle disorders beginning late this year. The program targets a population with limited options and seeks to establish safety and early signals of clinical activity. The company’s entry into clinical testing follows regulatory clearance at the FDA level, enabling the trial to move from preclinical development into human studies. The start timing suggests a near-term ramp into enrollment and initial data generation. For families and clinicians in urea cycle disorders, the clearance adds another investigational approach focused on early disease control through infant intervention rather than later-stage management.