IQ-AI Limited Imaging Biometrics granted FDA "Fast-Track" (3492X)
19 Dezember 2023 - 3:29PM
UK Regulatory
TIDMIQAI
RNS Number : 3492X
IQ-AI Limited
19 December 2023
IQ-AI Ltd
("IQ-AI" or the "Company")
Imaging Biometrics granted FDA "Fast-Track"
Dec 19, 2023 - Imaging Biometrics, LLC (IB), a wholly owned
subsidiary of IQ-AI Ltd (LSE: IQAI), is pleased to announce that
the U.S. Food and Drug Administration (FDA) has granted
"Fast-Track" designation for oral gallium maltolate (GaM), IB's
therapeutic for the treatment of adult patients with relapsed or
refractory glioblastoma (GBM), IDH-wildtype.
The FDA's decision to grant Fast-Track status reflects the
urgency and unmet medical need associated with GBM. 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.
Fast-Track designation offers an accelerated review process with
the FDA via increased communication and collaboration during the
development process. IB is now well positioned to utilize this
streamlined and efficient process to bring this promising agent to
the market as quickly as possible.
"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."
--ENDS -
The Directors of the Company accept responsibility for the
contents of this announcement.
For further information, please contact:
IQ-AI Ltd
Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda
Tel: 020 7469 0930
Peterhouse Capital Limited (Financial Adviser and Broker)
Lucy Williams/Heena Karani
Tel: 020 7220 9797
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December 19, 2023 09:29 ET (14:29 GMT)
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