Spruce Biosciences, Inc.
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- Spruce Biosciences, Inc. (SPRB) is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical needs. Founded in 2014 and headquartered in South San Francisco, California, the company advances a pipeline centered in neurology, including tralesinidase alfa (TA-ERT), an enzyme replacement therapy comprising recombinant human alpha-N-acetylglucosaminidase (rhNAGLU) fused with modified human insulin-like growth factor 2 for mucopolysaccharidosis type IIIB (MPS IIIB, or Sanfilippo Syndrome Type B), a rare neurodegenerative genetic disorder affecting approximately 1 in 200,000 newborns with no approved treatments; and tildacerfont (Cortibon), a corticotropin-releasing factor type 1 (CRF1) receptor antagonist small molecule partnered with HMNC Brain Health for major depressive disorder (MDD), accompanied by a companion diagnostic to identify responsive patients via genetic markers. TA-ERT holds Rare Pediatric Disease, Fast Track, and Orphan Drug designations from the FDA in the US and EU, with HS-NRE confirmed as a surrogate biomarker for accelerated approval. In a major strategic shift announced in April 2025, Spruce acquired an exclusive worldwide license for TA-ERT and related enzyme replacement therapies from BioMarin Pharmaceutical Inc. via an asset purchase from Allievex, pivoting from its prior emphasis on rare endocrine disorders like congenital adrenal hyperplasia to prioritize this near-term commercial opportunity in neurology; the company implemented a 1-for-75 reverse stock split effective August 2025, completed a $50.0 million private placement financing in October 2025 to support operations into Q4 2026, and received FDA Breakthrough Therapy designation for TA-ERT in October 2025, with a biologics license application (BLA) submission on track for the first half of 2026 and Phase 2 data for tildacerfont in MDD anticipated in the first half of 2026.
Company News
Spruce Biosciences Announces Launch of MPS3BStudy.com
Spruce Biosciences Announces Launch of MPS3BStudy.com
Spruce Biosciences Announces Positive Pre-BLA Meetings with FDA and Confirms BLA Submission for TA-ERT on Track for Q4 2026
Spruce Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates
Cure Sanfilippo Foundation and National MPS Society Make $5.5 Million Strategic Investment in Spruce Biosciences
Cure Sanfilippo Foundation and National MPS Society Make $5.5 Million Strategic Investment in Spruce Biosciences
Spruce Biosciences Appoints Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development
Spruce Biosciences Appoints Adrian Quartel, M.D., FFPM, as Chief Medical Officer
Spruce Biosciences to Participate in the B. Riley Securities 2026 Mind, Muscle & Vision Healthcare Summit
Spruce Biosciences Possibly First In-MPS IIIB Class Enzyme Replacement Therapy
Spruce Biosciences Joins the Russell 3000® Index
Spruce Biosciences Joins the Russell 3000® Index
Spruce Biosciences Appoints Agnieszka Jurecka, M.D., Ph.D., MPH, as Vice President, Medical Affairs
Spruce Biosciences Appoints Eric Jordan as Vice President, Marketing and Tina Gullotta as Vice President, Finance and Corporate Controller
Spruce Biosciences Announces Long-Term Tralesinidase Alfa Enzyme Replacement Therapy Data in Sanfilippo Syndrome Type B (MPS IIIB) Presented at the 18th International MPS Symposium
Spruce Biosciences Announces Data Presentation at the 18th International MPS Symposium
Spruce Biosciences to Participate in Upcoming Conferences in June
Spruce Biosciences Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Spruce Biosciences Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Spruce Biosciences Further Strengthens its Commercial Leadership Team with the Appointments of Brian Walls as Vice President, Market Access and Darren Johnson as Vice President, Commercial Operations