Spruce Biosciences' TA-ERT Secures FDA's Breakthrough Therapy Designation, Stock Surges
Spruce Biosciences, Inc. (SPRB), Monday announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to the company's tralesinidase alfa enzyme replacement therapy or TA-ERT for the treatment of Sanfilippo Syndrome Type B, an ultra-rare, serious, and fatal genetic disease.The designation is backed by the integrated group-level clinical data, demonstrating a rapid, profound, and durable effect of TA-ERT in normalizing Cerebral Spinal Fluid Heparan Sulfate Non-Reducing En ...