07:19 AM EDT, 08/08/2024 (MT Newswires) -- Satellos Bioscience ( MSCLF ) on Thursday said the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to its lead candidate SAT-3247 for the potential treatment of Duchenne muscular dystrophy (DMD).
SAT-3247, which had received Orphan Drug Designation earlier this year, is a first-in-class oral small molecule therapeutic designed to restore the innate muscle regeneration and repair process.
"Obtaining the Rare Pediatric Disease and Orphan Drug Designations for SAT-3247 from the FDA are important milestones for Satellos as we continue to progressively build value in our DMD program," said Frank Gleeson, CEO and co-founder of Satellos. "The Rare Pediatric Disease Designation for SAT-3247 highlights the continued need for new disease modifying therapeutic options for pediatric patients with Duchenne, a need which we believe SAT-3247 has the potential to address."