The U.S. Food and Drug Administration (FDA) placed a clinical hold on Quantum BioPharma Ltd.’s Investigational New Drug (IND) application for Lucid-MS. This therapeutic candidate targets multiple sclerosis.
The agency requires additional information before the company can begin its planned Phase 2 clinical trial. Quantum BioPharma is reviewing the feedback and plans to work with the FDA to resolve the concerns.
The company formally withdrew all previously disclosed timelines for the FDA review and trial commencement. Management believes the issues identified by the regulator are addressable.