Shares of Spruce Biosciences, Inc. ( SPRB ) are surging Monday after the biotech company shared an important regulatory update about one of its therapy treatments.

What To Know: Spruce Biosciences ( SPRB ), which produces novel therapies for neurological disorders, said the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for its tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B.

Spruce Biosciences ( SPRB ) shares soared more than 250% following the news. The stock was trading around $31.50 at the time of writing, according to Benzinga Pro.

Sanfilippo Syndrome Type B is an ultra-rare, serious and fatal genetic disease characterized by deficiency in N-Acetyl-Alpha-Glycosaminidase (NAGLU), an enzyme required for the catabolism of heparan sulfate (HS) in lysosomes. TA-ERT therapy is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU).

The company said that its biologics license application submission of TA-ERT for Sanfilippo Syndrome Type B remains on track for the first quarter of 2026.

"We are pleased to receive U.S. FDA Breakthrough Therapy Designation as we prepare to submit the Biologics License Application of TA-ERT for the treatment of MPS IIIB 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, CEO of Spruce Biosciences ( SPRB ).

SPRB Price Action: Shares of Spruce Biosciences ( SPRB ) were up 257.71% at $31.55 at the time of publication on Monday, according to Benzinga Pro.

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