Regulatory StrategyManagement's new strategy involves multiple meetings with the FDA to ensure thorough discussions on critical topics, aiming for a clearer pathway to accelerated approval.
Safety ProfileThe company reported a strong safety profile with zero drug-induced liver injury and detection of lower AST/ALT levels, indicating muscle recovery.
Therapeutic PotentialSGT-003's therapeutic potential for Duchenne muscular dystrophy remains strong and competitive, solidifying its status as a best-in-class treatment.