SPRB Stock Drops After Company Pushes Back Application Submission Timeline For Experimental Sanfilippo Syndrome Therapy

• The company had previously said that it expects to submit an application for approval of the therapy in the first quarter of 2026.
• In the December meeting with the FDA, the company discussed its clinical data and regulatory strategy. 
• In the second meeting, in January, it discussed chemistry, manufacturing, and controls (CMC) requirements.

Shares of Spruce Biosciences, Inc. (SPRB) fell 8% on Wednesday after the company pushed back on its timeline to submit an application to the U.S. Food and Drug Administration seeking approval for its enzyme replacement therapy in patients with Sanfilippo Syndrome Type B.

The company said that it completed two meetings with the FDA regarding its planned upcoming biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy (TA-ERT) in the treatment of Sanfilippo syndrome type B.

While the first meeting was held in Dec. 2025, the second was held in Jan. 2026. In the December meeting, the company discussed its clinical data and regulatory strategy, while in the second meeting, it discussed chemistry, manufacturing, and controls (CMC) requirements.

The company now anticipates making the submission for TA-ERT in the fourth quarter of 2026 to accommodate the clinical and other requirements flagged by the FDA in the meetings. Spruce Biosciences had previously said that it expects to submit an application for approval of the therapy in the first quarter of 2026.

About 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.

“While the timing of our submission is now expected in the fourth quarter of this year, we believe in the strength of our long-term data for TA-ERT which demonstrates that reductions in CSF HS-NRE are associated with meaningful clinical benefits across cognition, communication, and motor skill acquisition,” CEO Javier Szwarcberg said.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around SPRB stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.

SPRB stock has gained nearly 372% over the past 12 months. 

Read More: Why Did MBRX Stock Climb 14% Today?

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