Why Did Spruce Biosciences Stock Quadruple Today?

Spruce Biosciences (SPRB) on Monday said that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B.

Sanfilippo syndrome type B (MPS IIIB) is a rare, inherited lysosomal storage disease caused by a deficiency in the enzyme alpha-N-acetylglucosaminidase, leading to the accumulation of heparan sulfate in cells, particularly neurons. It causes progressive neurological symptoms like cognitive and developmental impairment, hyperactivity with aggressive and destructive behavior, delayed speech, hearing loss, and motor skill deficits.

Tralesinidase Alfa Enzyme Replacement Therapy is intended as an enzyme replacement therapy for the treatment of patients with MPS IIIB. The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions. It enables intensive FDA guidance and eligibility for rolling submission and priority review.

Shares of SPRB traded 314% higher at the time of writing on Monday. On Stocktwits, retail sentiment around SPRB stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours while message volume stayed at ‘extremely high’ levels.

CEO Javier Szwarcberg said that the company is preparing to submit an application for approval of the therapy in MPS IIIB in the first quarter of 2026. According to Spruce, Sanfilippo Syndrome Type B affects one in 200,000 people in the U.S.

Currently, there are no FDA-approved therapies for the disease, which drastically brings down the life expectancy of individuals to 15-19 years of age.

SPRB stock rose over 200% over the past 12 months. 

Read also: US-Listed Nyxoah Shares Soar On First Genio System Implants In Patients With Sleep Disorder

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