Imaging Biometrics Ltd (LSE:IBAI, OTCQB:IQAIF), a specialist in imaging-based therapies for brain cancers, said it will revise its application for Breakthrough Therapy Designation in the US, following discussions with the Food and Drug Administration.
The company is developing oral gallium maltolate, a treatment aimed at aggressive brain tumours that have not responded to standard therapies. It had submitted the drug for consideration under the FDA's Breakthrough Therapy programme, which is designed to fast-track promising new treatments.
US regulators have now advised the company to resubmit the application with a more mature data package.
Imaging Biometrics said the FDA responded positively to initial results and encouraged a revised submission once further analysis is complete.
The company said it is now working to incorporate new biomarker and imaging data to strengthen the case for the drug. Gallium maltolate remains a key part of its strategy to bring innovative therapies into neuro-oncology.