Spruce Biosciences (NASDAQ:SPRB) stock surged 60% after the company announced it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B.
The FDA designation, which expedites development and regulatory review for promising therapies addressing serious conditions, was supported by integrated long-term clinical data showing normalization in cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE). Notably, the FDA confirmed that CSF HS-NRE could serve as a surrogate biomarker reasonably likely to predict clinical benefit, potentially enabling accelerated approval.
Spruce Biosciences, a late-stage biopharmaceutical company focused on developing therapies for neurological disorders, remains on track to submit its Biologics License Application for TA-ERT in the first quarter of 2026.
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