Spruce Biosciences says FDA pre-BLA meetings support TA-ERT filing in Q4 2026

PUBT · 3d ago
Spruce Biosciences says FDA pre-BLA meetings support TA-ERT filing in Q4 2026
  • 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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