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Spruce Biosciences Announces Positive Pre-BLA Meetings with FDA and Confirms BLA ...
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Fusion42 · 24 August 2026 · Fusion42 review
Spruce Biosciences completed positive pre-BLA meetings with the FDA confirming alignment on the content, format, and manufacturing comparability for its biologics license application (BLA) of tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B, on track for Q4 2026 submission under the accelerated approval pathway.
This Wire brief sits within Fusion42's coverage of Biotech.
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You have a clear regulatory path with the FDA for a rare disease biologic thanks to Spruce’s alignment on manufacturing and clinical data standards. This opens a window to pursue accelerated approval strategies that can shorten time to market in highly specialised therapies.
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1 source · 24 Aug 2026
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