Spruce Biosciences Stock Surges Over 1,300% on FDA Breakthrough Therapy Designation

Spruce Biosciences (SPRB) witnessed an unprecedented rally, with shares skyrocketing more than 1,378.5% in a single trading session. The surge followed the U.S. FDA's decision to grant breakthrough therapy designation to its experimental drug, tralesinidase alfa (TA-ERT), for treating Sanfilippo Syndrome Type B—a rare genetic disorder affecting the brain and nervous system.

The FDA's designation accelerates the drug's development pathway, offering Spruce Biosciences enhanced regulatory guidance and the ability to use cerebrospinal fluid biomarkers for efficacy measurement. Long-term clinical data showing normalization of heparan sulfate levels bolstered the decision. After-hours trading added another 34.2% to the stock's meteoric rise.

As a late-stage biopharmaceutical firm focused on rare endocrine disorders, Spruce now stands at a pivotal juncture. Investors are weighing the potential for expedited approval against the inherent risks of clinical-stage biotech volatility.