Aptorum Group Limited announced the completion of an end of Phase 1 (EOP1) meeting with the US Food and Drug Administration ("US FDA"). SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and has also received orphan drug designation previously from the US FDA. The EOP1 meeting was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma in pediatric patients aged 2-18.

The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and proposed clinical development plan for Phase 1/2 trials.