News Releases

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.

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE)-- Spruce 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 that Javier Szwarcberg, M.D.,

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,