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IQ-AI subsidiary gets second FDA rare paediatric disease designation

ALN

IQ-AI Ltd on Monday said its subsidiary, Imaging Biometrics LLC, received a second rare paediatric disease designation by the US Food & Drug Administration for its IB-003 lead drug candidate oral gallium maltolate.

The London-based medical services company acquired Imaging Biometrics, a Wisconsin-based healthcare imaging software firm, in 2018.

On May 10, the FDA granted IB-003 the designation for the treatment of atypical teratoid rhabdoid tumors.

The designation firms both strategic and financial advantages in advancing treatments, IQ-AI said.

These most importantly include priority review vouchers, which can then be redeemed to obtain a priority review for a product.

A second designation has now also been granted by the FDA for the treatment of paediatric-type diffuse high grade glioma.

IQ-AI’s Chief Executive Officer Trevor Brown commented: ‘Building upon these designations, we are exploring ways to accelerate and expand the application of IB-003.’

IQ-AI shares were down 0.2% to 1.48 pence each in London on Monday morning.

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