Spruce Biosciences, Inc. shares rise over 310.0%, currently trading at $35.94

Spruce Biosciences, Inc. shares rise over 310.0%, currently trading at $35.94

Spruce Biosciences, Inc. (NASDAQ: SPRB) experienced a significant surge in its stock price, rising over 310% and currently trading at $35.94. The dramatic increase is attributed to the company's announcement of receiving Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B .

The FDA Breakthrough Therapy Designation is granted to therapies that address serious or life-threatening conditions and demonstrate substantial improvement over existing therapies. This designation provides Spruce Biosciences with more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review, potentially accelerating the path to market for TA-ERT .

Sanfilippo Syndrome Type B is an ultra-rare, fatal genetic disease affecting fewer than 1:200,000 people in the United States. The condition is characterized by deficiency in N-Acetyl-Alpha-Glycosaminidase, an enzyme required for breaking down heparan sulfate in lysosomes. Currently, there are no FDA-approved therapies for the condition, with management limited to palliative care. 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. "This designation highlights TA-ERT’s potentially transformative clinical impact as the first disease-modifying therapy to treat MPS IIIB in children impacted by this devastating condition," said Javier Szwarcberg, Chief Executive Officer of Spruce Biosciences .

This news has significantly boosted investor confidence in Spruce Biosciences, leading to a substantial increase in its stock price. The company's focus on developing innovative treatments for rare and life-threatening conditions has positioned it as a leader in the biopharmaceutical sector.