Spruce Biosciences Secures FDA Breakthrough Therapy Designation for Tralesinidase Alfa in Sanfilippo Syndrome Type B
Reuters
Oct 06
Spruce Biosciences Secures FDA Breakthrough Therapy Designation for Tralesinidase Alfa in Sanfilippo Syndrome Type B
**Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Sanfilippo Syndrome Treatment** Spruce Biosciences, Inc. (Nasdaq: SPRB) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB). This designation is intended to expedite the development and regulatory review of promising treatments for serious conditions and is based on preliminary clinical evidence demonstrating TA-ERT's potential to significantly improve patient outcomes. Spruce Biosciences plans to submit a Biologics License Application for TA-ERT in the first quarter of 2026. No other organizations were named as recipients of this regulatory designation.
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