Spruce Biosciences targets Q4 2026 BLA filing for TA-ERT in Sanfilippo syndrome type B after FDA meetings - SPRB News | RalliesSpruce Biosciences targets Q4 2026 BLA filing for TA-ERT in Sanfilippo syndrome type B after FDA meetings
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SPRB• FDA meetings support planned BLA submission
- Spruce Biosciences reported positive pre-BLA meetings with the FDA for TA-ERT in Sanfilippo syndrome Type B.
- No new clinical trial results were presented; the update focused on regulatory alignment ahead of a planned BLA submission in Q4 2026.
- The FDA discussions supported Spruce’s plan to seek accelerated approval based on biomarker evidence intended to predict clinical benefit.
- Spruce expects to start a confirmatory study during the FDA’s review, positioning TA-ERT for a potential first disease-modifying launch if cleared.
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