Spruce Biosciences Soars 1400% on FDA Breakthrough Drug News
FDA grants Breakthrough Therapy Designation for the company's treatment of Sanfilippo Syndrome, a rare neurodegenerative disorder.
Shares of Spruce Biosciences (SPRB) skyrocketed more than 1,400% in a stunning rally Monday, driven by the U.S. Food and Drug Administration's decision to grant to its leading drug candidate, tralesinidase alfa.
The designation is for the treatment of Sanfilippo Syndrome Type B (MPS IIIB), a rare and fatal pediatric neurodegenerative disease with no cure. This regulatory milestone is intended to expedite the development and review of drugs that treat serious conditions and have shown preliminary clinical evidence of substantial improvement over available therapies.
Sanfilippo Syndrome Type B is a lysosomal storage disorder that leads to severe cognitive decline, often described as a form of childhood dementia, and premature death. According to the , the disease is caused by a genetic mutation that prevents the body from breaking down long chains of sugar molecules, leading to toxic accumulation in the brain.
The market's reaction to the news was immediate and explosive. Spruce's stock surged 1,378% during regular trading hours, followed by an additional , on extremely high trading volume as investors scrambled to price in the drug's enhanced prospects.
Spruce's therapy, tralesinidase alfa, is an enzyme replacement therapy designed to address the underlying cause of the disease by replacing the missing enzyme in the central nervous system. The FDA's decision was supported by long-term clinical data indicating the therapy could stabilize or slow the progression of the devastating disorder.
With this designation, Spruce Biosciences is better positioned for a potentially accelerated approval pathway. The company has stated it plans to submit its Biologics License Application for the therapy in the first quarter of 2026, offering a glimmer of hope for patients and families affected by this ultra-rare condition.