IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) subsidiary Imaging Biometrics has been awarded fast-track designation for its oral gallium maltolate (GaM) therapeutic for the treatment of adult patients with relapsed or refractory glioblastoma (GBM), IDH-wildtype.
Receiving both Fast-Track and Orphan Drug designations from the FDA for oral GaM validates the importance of advancing the development of this treatment for these patients, IQ-AI added.
Fast-Track designation offers an accelerated review process with the FDA via increased communication and collaboration during the development process.
"We are very pleased to receive Fast Track designation," said Trevor Brown, CEO of IQ-AI.
"This is an important milestone as well as a commercial accelerator, and we are firmly committed to working closely with the FDA to expedite the clinical development of oral GaM."