IQ-AI’s Imaging Biometrics Seeks FDA Breakthrough Designation for GaM Therapy
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Fiona Craig
PUBLISHED:
May 02 2025 @ 03:14
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IQ-AI Limited (LSE:IQAI) has announced that its subsidiary, Imaging Biometrics, has applied for the FDA’s Breakthrough Therapy Designation for its oral gallium maltolate (GaM) therapy. The therapy is being developed for the treatment of recurrent or refractory glioblastoma (GBM) IDH-wildtype. Early results from the Phase 1 trial show a promising overall survival rate of 34.1 months, a significant improvement compared to the median of 14-15 months for standard treatments. If granted, the Breakthrough Therapy Designation would provide the company with more intensive guidance and support from the FDA, potentially enhancing its market position and offering renewed hope for more effective GBM treatments.
About IQ-AI Limited
Imaging Biometrics, LLC, a wholly-owned subsidiary of IQ-AI Limited, specializes in quantitative imaging platforms and therapeutics. The company is dedicated to enhancing clinical diagnosis and treatment efficiency, aiming to improve the effectiveness of medical interventions.
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