(RTTNews) - 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 End, as well as stabilizing cortical grey matter volume and cognitive function in children.
The company plans to submit the Biologics License Application of TA-ERT in the first quarter of 2026.
In the pre-market hours, SPRB is soaring 135.4 percent, to $20.83 on the Nasdaq.
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