Spruce Biosciences, Inc. SPRB
Spruce Biosciences, Inc. (Nasdaq: SPRB) is a rare genetic drug developer. Its lead program, TA-ERT (tralesinidase alfa), is in Phase 2 for Mucopolysaccharidosis IIIB (Sanfilippo B). Its next catalyst on record is TA-ERT: BLA submission for accelerated approval (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TA-ERT — BLA submission for accelerated approval (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TA-ERT TrAnsform confirmatory study | MPS IIIB | protein/peptide | Phase 3 |
| TA-ERT | MPS IIIB | protein/peptide | Phase 2 |
Recent results and decisions
- Mar 9, 2026n/a Two positive FDA Type B meetings: integrated study and natural history data could serve as adequate and well-controlled study supporting accelerated approval on CSF heparan sulfate surrogate.
The FDA confirmed that the integrated study data from interventional clinical studies of TA-ERT and the available natural history data could potentially serve as an adequate and well-controlled study
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.