REG - Imaging Biometrics - IB Provides Update on BTD Application
12/06/2025 10:45
For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250612:nRSL5919Ma&default-theme=true
RNS Number : 5919M Imaging Biometrics Limited 12 June 2025
Imaging Biometrics, Ltd
("IB" or the "Company")
Imaging Biometrics Provides Update on Breakthrough Therapy Designation
Application
Imaging Biometrics, Ltd, a leader in quantitative imaging solutions and novel
therapies for CNS malignancies, today announces that following recent dialogue
with the U.S. Food and Drug Administration (FDA), the Company was encouraged
to voluntarily withdraw and resubmit its Breakthrough Therapy Designation
(BTD) application for oral gallium maltolate (GaM), an investigational
treatment targeting refractory brain tumors.
The FDA's recommendation stems from a shared recognition of the potential
impact of the agent and a mutual desire to ensure the application reflects the
most compelling and mature data. The agency expressed enthusiasm for
preliminary findings and suggested that resubmission after completion of an
expanded data analysis would strengthen the submission and facilitate review.
"We view this feedback as an encouraging step forward," said Trevor Brown, CEO
of Imaging Biometrics Ltd. "We believe the FDA's interest reinforces the
scientific rationale behind GaM and supports our mission to accelerate new
treatment options for patients facing devastating brain tumors. We are
diligently working to incorporate additional biomarker and imaging efficacy
data that will provide a more comprehensive picture of its therapeutic
potential."
Imaging Biometrics anticipates resubmitting the BTD application as part of its
broader regulatory and clinical strategy. The Company remains committed to the
advancement of innovative technologies that intersect imaging intelligence
with novel therapeutics to improve outcomes in neuro-oncology.
--ENDS-
The Directors of the Company accept responsibility for the contents of this
announcement.
For further information, please contact:
IB Ltd
Trevor Brown/Dr Al Musella/Brett Skelly/Michael Schmainda
Tel: 020 7469 0930
Peterhouse Capital Limited (Financial Adviser and Broker)
Tel: 020 7220 9797
About Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of Imaging
Biometrics Limited, (LON: IBAI), and focuses on delivering quantitative
imaging platforms and therapeutics that transform how clinicians diagnose and
treat patients more efficiently and effectively. For more information about
Imaging Biometrics, visit the company's website at www.imagingbiometrics.com
(http://www.imagingbiometrics.com/) . Follow IB on X, @ImgBiometrics.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END STRKLLBFEQLLBBQ