08:57 AM EDT, 10/06/2025 (MT Newswires) -- Spruce Biosciences ( SPRB ) said Monday that its tralesinidase alfa enzyme replacement therapy, or TA-ERT, has been granted Breakthrough Therapy Designation by the US Food and Drug Administration for the treatment of Sanfilippo Syndrome Type B.

The FDA's decision was supported by long-term clinical data showing normalization of heparan sulfate non-reducing ends in cerebral spinal fluid, Spruce Biosciences ( SPRB ) said.

The FDA also confirmed the biomarker as a surrogate reasonably likely to predict clinical benefit and could serve as the basis for accelerated approval, the company said.

Spruce Biosciences ( SPRB ) said it plans to submit a biologics license application for TA-ERT in Q1 2026.

Shares of Spruce Biosciences ( SPRB ) were up 127% in recent Monday premarket activity.