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 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.
- Drug:
- TA-ERT
- Announced Date:
- October 6, 2025
- Indication:
- for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).
Announcement
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).
AI Summary
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.
Read Announcement
Spruce Biosciences FDA Events - Frequently Asked Questions
As of now, Spruce Biosciences (SPRB) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Spruce Biosciences (SPRB) has reported FDA regulatory activity for TA-ERT.
The most recent FDA-related event for Spruce Biosciences occurred on October 6, 2025, involving TA-ERT. The update was categorized as "Designation Grant," with the company reporting: "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)."
Currently, Spruce Biosciences has one therapy (TA-ERT) targeting the following condition: for the treatment of Sanfilippo Syndrome Type B (MPS IIIB)..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SPRB) was last updated on 10/6/2025 by MarketBeat.com Staff
