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.
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
Spruce Biosciences Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants
Spruce Biosciences Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Wall Street Analysts Believe Spruce Biosciences (SPRB) Could Rally 181.21%: Here's is How to Trade
Does Spruce Biosciences (SPRB) Have the Potential to Rally 208.32% as Wall Street Analysts Expect?
Spruce Biosciences Reports Full Year 2025 Financial Results and Provides Corporate Updates
Spruce Biosciences Appoints Dale Hooks, an Accomplished Rare Disease Commercial Leader, as Chief Commercial Officer
Spruce Biosciences Touts MPS IIIB Data, Targets Q4 BLA Submission at Oppenheimer Conference
Spruce Biosciences to Present at Upcoming Investor Conferences in March
Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
Spruce Biosciences to Participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Long-Term Data Presented at the 22nd Annual WORLDSymposium™ Highlights Tralesinidase Alfa Enzyme Replacement Therapy's Potential as the First Disease-Modifying Treatment Option for Sanfilippo Syndrome Type B (MPS IIIB)
Spruce Biosciences Adds Regulatory and Clinical Development Expertise to Leadership Team
Spruce Biosciences Announces Data Presentations at the 22nd Annual WORLDSymposium™
Big-Pharma Partner Harbour BioMed Boosts Stake In Spruce Biosciences
Harbour BioMed Acquires Common Stock in Spruce Biosciences, Deepening Strategic Collaboration