Website Enables Families and Caregivers of Children with MPS IIIB to Learn About and Register Interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform Confirmatory Study TA-ERT EAP and TrAnsform Confirmatory Study Both Expected to Initiate in the Fourth Quarter of 2026 SOUTH SAN
FDA Found Spruce's Chemistry, Manufacturing and Controls (CMC) Comparability Strategies Reasonable to Support the BLA Following Technology Transfer to Leading Global Biologics Manufacturer Spruce and FDA Aligned on the Overall Content and Format of the Planned BLA, Including Structure of the
Biologics License Application (BLA) for TA-ERT for the Treatment of MPS IIIB Anticipated in the Fourth Quarter of 2026 TrAnsform Confirmatory Study Required for Potential FDA Accelerated Approval of TA-ERT Expected to Initiate in the Fourth Quarter of 2026 Strengthened Leadership Team with the
Investment Broadens Patient Access to Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for Sanfilippo Syndrome Type B in the TA-ERT Expanded Access Program (EAP) TA-ERT EAP Expected to Initiate in the Fourth Quarter of 2026 SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Aug.
Dr. Cohen Pfeffer Brings More Than a Decade of Clinical Development Leadership, Including Deep Experience with Enzyme Replacement Therapies for Rare Pediatric Neurodegenerative Disorders SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Aug. 3, 2026-- Spruce Biosciences, Inc.
Accomplished Rare Disease Drug Developer Brings More Than 25 Years of Global Clinical Development and Medical Affairs Leadership, Including the Launch of Multiple Enzyme Replacement Therapies for Rare Pediatric and Genetic Disorders SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Jul.
Inclusion Reflects Spruce’s Momentum as the Company Advances Toward a Planned Biologics License Application (BLA) Submission and Potential Commercial Launch of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN FRANCISCO, Calif.
Dr. Jurecka Brings Deep Enzyme Replacement Therapy and Rare Disease Experience to Lead Medical Affairs and Scientific Engagement Ahead of Potential U.S. FDA Approval of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN
Appointments Further Strengthen Spruce’s Commercial and Financial Capabilities as the Company Approaches a Potential U.S. FDA Approval and Commercial Launch of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN FRANCISCO,
Data Highlight TA-ERT’s Potential as the First Disease-Modifying Treatment Option for MPS IIIB, a Fatal Condition With No Approved Therapies Treatment With Weekly TA-ERT Demonstrated Rapid and Durable Normalization of CSF Heparan Sulfate Non-Reducing End (CSF HS-NRE), a Surrogate Endpoint