Spruce Biosciences Stock Soars Over 1400% on FDA Drug Designation
FDA grants Breakthrough Therapy status for a promising new drug targeting the rare and fatal Sanfilippo Syndrome Type B.
Shares of Spruce Biosciences (SPRB) skyrocketed in a staggering 1,434% rally on unprecedented trading volume after the U.S. Food and Drug Administration (FDA) granted a key designation to its leading drug candidate.
The biotechnology firm announced it had received for tralesinidase alfa, an enzyme replacement therapy aimed at treating Sanfilippo Syndrome Type B (MPS IIIB). The disease is a rare, fatal pediatric genetic disorder that causes severe neurodegeneration and for which there are currently no approved treatments.
The Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The FDA's decision was based on clinical data showing the therapy normalized a key biomarker, CSF HS-NRE, which the agency deemed 'reasonably likely to predict clinical benefit.' This finding could pave the way for a faster path to market under the FDA's accelerated approval pathway.
The market's reaction was immediate and explosive, with Spruce's stock price surging on more than 400 times its average trading volume. The move represents a significant turnaround for the company, which previously pivoted to developing tralesinidase alfa after a different drug candidate failed a late-stage trial.
Despite the monumental stock rally, , pointing to the company's financial position and the inherent challenges of commercializing a therapy for an ultra-rare disease. The company's future success will depend on its ability to secure further funding and successfully navigate the final stages of the regulatory process.
Spruce Biosciences has stated it is on track to submit a Biologics License Application (BLA) for the therapy in the first quarter of 2026. The therapy also holds Fast Track, Orphan Drug, and Rare Pediatric Disease designations in the U.S. and E.U., which could provide further regulatory and commercial advantages. The combination of a promising drug for an unmet medical need and a potential Priority Review Voucher has also positioned Spruce as a in the biotech space.