InhaleRx Faces FDA Hold on New Drug Trial

InhaleRx Limited (AU:IRX) has released an update.

InhaleRx Limited has announced a temporary FDA suspension of its IND application for a phase 1 clinical trial of IRX616a, aimed at treating Panic Disorder, to address safety concerns. The company is awaiting further FDA communication and is preparing a comprehensive response while continuing its drug development plans in Australia, where IND is not required for early-phase trials. CEO Darryl Davies expressed commitment to resolving the FDA’s concerns and advancing the treatment’s development.

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