Spruce Biosciences' TA-ERT Secures FDA's Breakthrough Therapy Designation, Stock Surges

Core Insights - Spruce Biosciences, Inc. has received Breakthrough Therapy Designation from the U.S. FDA for its enzyme replacement therapy, TA-ERT, aimed at treating Sanfilippo Syndrome Type B, a rare and fatal genetic disorder [1][2] Group 1: FDA Designation and Clinical Data - The Breakthrough Therapy Designation is supported by clinical data showing that TA-ERT has a rapid, profound, and durable effect on normalizing Cerebral Spinal Fluid Heparan Sulfate Non-Reducing End [2] - The therapy also stabilizes cortical grey matter volume and cognitive function in children affected by the disease [2] Group 2: Future Plans and Market Reaction - The company plans to submit the Biologics License Application for TA-ERT in the first quarter of 2026 [2] - Following the announcement, Spruce Biosciences' stock surged by 135.4 percent, reaching $20.83 in pre-market trading on Nasdaq [3]