Imaging Biometrics LLC

IQ-AI Seeks FDA Breakthrough Therapy Designation for Promising Glioblastoma Treatment

22 days ago

• IQ-AI's subsidiary Imaging Biometrics has applied for FDA Breakthrough Therapy Designation for its oral gallium maltolate therapy targeting recurrent or refractory glioblastoma IDH-wildtype. • Preliminary Phase 1 trial results show an overall survival of 34.1 months from initial diagnosis, significantly exceeding the standard treatment median survival of 14-15 months. • The FDA is required to respond to the application within 60 days, with Breakthrough Designation potentially providing more intensive FDA guidance and senior-level organizational support than the previously received Fast Track Designation.