Posted by Michael Wonder on 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate non-reducing end.
Spruce Biosciences today announced that the US FDA has granted breakthrough therapy designation to tralesinidase alfa enzyme replacement therapy for the treatment of Sanfilippo syndrome type B.
