Spruce Biosciences says FDA pre-BLA meetings support TA-ERT filing in Q4 2026 - SPRB News | RalliesSpruce Biosciences says FDA pre-BLA meetings support TA-ERT filing in Q4 2026
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SPRB• FDA pre-BLA meetings support planned filing
- Spruce Biosciences completed two pre-BLA meetings with the FDA for TA-ERT in Sanfilippo syndrome type B.
- BLA submission remains on track for Q4 2026, using the accelerated approval pathway based on reduction in CSF HS-NRE.
- FDA backed the CMC comparability approach following manufacturing technology transfer, supporting the planned filing.
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