Posted by Michael Wonder on 02 Jul 2026
INTENT Biologics receives FDA breakthrough therapy designation for PEP Biologic for its Phase 3 ready flagship indication
1 July 2026 - INTENT Biologics announced today that the US FDA has granted breakthrough therapy designation for PEP Biologic for the treatment of diabetic foot ulcers under IND 019567.
PEP Biologic (Purified Exosome Product) is a first-in-class exosome therapeutic discovered through Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program and developed on RION’s industry-leading platelet-derived exosome biomanufacturing platform.
