Spruce Biosciences (SPRB) FDA Approvals

Spruce Biosciences' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Spruce Biosciences (SPRB). Over the past two years, Spruce Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TA-ERT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

TA-ERT FDA Regulatory Timeline and Events

TA-ERT is a drug developed by Spruce Biosciences for the following indication: for the treatment of Sanfilippo Syndrome Type B (MPS IIIB). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Meeting - February 18,2026

FDA Type B Meeting

• Drug: TA-ERT
• Announced Date: February 18, 2026
• Indication: for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

Spruce Biosciences, Inc. announced the successful completion of Type B meetings with the U.S. Food and Drug Administration (FDA or the Agency) regarding its planned upcoming biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy (TA-ERT).

Spruce Biosciences announced it has successfully completed Type B meetings with the U.S. Food and Drug Administration about its planned biologics license application (BLA) for tralesinidase alfa enzyme replacement therapy (TA-ERT). The company said the discussions support its regulatory pathway and next steps toward filing the BLA.

Based on FDA feedback, Spruce will use cerebrospinal fluid (CSF) heparan sulfate non-reducing end (HS‑NRE) as a reasonably likely surrogate endpoint to support an accelerated approval approach for TA‑ERT. To meet manufacturing expectations, the company now anticipates submitting the BLA in the fourth quarter to allow completion of drug product process performance qualification (PPQ).

TA‑ERT is being developed as an enzyme replacement for patients with Sanfilippo syndrome type B. Spruce plans to continue preparing its clinical, CMC, and regulatory materials for the upcoming BLA submission.

Data - February 5,2026

• Drug: TA-ERT
• Announced Date: February 5, 2026
• Indication: for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

Spruce Biosciences, Inc announced that data from two different analyses presented today at the 22nd Annual WORLDSymposium™ demonstrate that the long-term administration of tralesinidase alfa enzyme replacement therapy (TA-ERT) resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive outcomes in patients with Sanfilippo Syndrome Type B (MPS IIIB) relative to natural history patients.

Spruce Biosciences reported analyses showing that long-term weekly tralesinidase alfa enzyme replacement therapy (TA-ERT), delivered intracerebroventricularly, produced rapid and durable normalization of cerebrospinal fluid heparan sulfate non-reducing end (CSF HS‑NRE), a surrogate endpoint reasonably likely to predict clinical benefit. In 22 patients treated and followed up to six years, TA-ERT stabilized and preserved cognitive and non-cognitive outcomes — including receptive and expressive communication and fine and gross motor skills — compared with declines seen in untreated natural history patients. These functional findings were supported by results on the validated Vineland Adaptive Behavior Scales (VABS‑II).

The safety profile was consistent with intracerebroventricular administration across roughly 6,000 doses over six years, with no new safety signals reported in these analyses. Overall, the data suggest long-term TA‑ERT can reduce a key disease biomarker and slow clinical decline in Sanfilippo Syndrome Type B (MPS IIIB) versus historical controls.

Designation Grant - October 6,2025

Breakthrough Therapy

• Drug: TA-ERT
• Announced Date: October 6, 2025
• Indication: for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

Spruce Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

Spruce Biosciences announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to tralesinidase alfa enzyme replacement therapy (TA-ERT) for treating Sanfilippo Syndrome Type B (MPS IIIB). TA-ERT is designed to replace the missing N-acetyl-alpha-glucosaminidase (NAGLU) enzyme in the central nervous system, aiming to stop or slow the fatal neurodegeneration seen in affected children.

This designation is supported by integrated long-term clinical data showing TA-ERT rapidly normalizes cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE), the key pathogenic factor in MPS IIIB. Treated patients also demonstrated stable cortical grey matter volume and preserved cognitive function over multiple years.

The FDA confirmed CSF HS-NRE as a surrogate biomarker reasonably likely to predict clinical benefit, potentially enabling accelerated approval. Spruce remains on track to submit its Biologics License Application for TA-ERT in the first quarter of 2026, hoping to deliver the first disease-modifying therapy for this ultra-rare disorder.