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Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
Based on FDA Feedback, Company Continues to Advance BLA Submission for TA-ERT Using CSF HS-NRE as Reasonably Likely Surrogate Endpoint for Accelerated
About this update from Spruce Biosciences, Inc.
[{"type":"text","content":"\nBased on FDA Feedback, Company Continues to Advance BLA Submission for TA-ERT Using CSF HS-NRE as Reasonably Likely Surrogate Endpoint for Accelerated Approval\n\n\nBLA Submission for TA-ERT is Now Anticipated in the Fourth Quarter to Accommodate Drug Product PPQ Requirement\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nSpruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the successful completion of Type B meetings with the U.S. Food and Drug Administration (FDA or the Agency) regarding its planned upcoming biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy (TA-ERT).\n\n\nThe company held two Type B meetings with the FDA ahead of its anticipated BLA submission for TA-ERT; the first in December 2025 to discuss the company’s clinical data and regulatory strategy, and the second in January 2026 to discuss chemistry, manufacturing, and controls (CMC) requirements.\n\n\nDuring the December 2025 meeting, the Agency 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 for purposes of the Agency’s review of the effects of TA-ERT on cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE), which could serve as a reasonably likely surrogate endpoint (RLSE) to support an accelerated approval. The Agency also provided recommendations to further support CSF HS-NRE as a RLSE, which the company is incorporating into its planned BLA submission. In addition, Spruce and the Agency discussed the timing and design of a required confirmatory study of TA-ERT, including an agreement to initiate the confirmatory study during BLA review.\n\n\nFollowing the January 2026 CMC meeting, the Agency considered the company’s plan to address drug product (DP) process performance qualification (PPQ) batch requirements for the BLA submission. In the official meeting minutes, which were received on February 12, 2026, the Agency shared its requirement for one DP PPQ batch at the time of BLA submission and data from a second DP PPQ batch prior to midcycle of BLA review. To accommodate this requirement,...