Spruce Biosciences, Inc.

Spruce Biosciences, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for rare endocrine disorders and neurological conditions with significant unmet medical needs. The company's mission is to advance targeted, first-in-class therapies for serious, underserved neurological conditions, driven by a commitment to patients and their families. Spruce Biosciences is headquartered in South San Francisco, California.

Spruce Biosciences' primary operational focus is the development of Tralesinidase Alfa (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB), an ultra-rare, fatal genetic disease for which there are currently no approved treatments. The company is also developing tildacerfont and Cortibon for Major Depressive Disorder (MDD). Previously, tildacerfont was under development for congenital adrenal hyperplasia (CAH), but that program has been halted.

In October 2025, Spruce Biosciences received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TA-ERT for Sanfilippo Syndrome Type B, a designation that expedites development and regulatory review. The company anticipates submitting a Biologics License Application (BLA) for TA-ERT in the fourth quarter of 2026. Javier Szwarcberg serves as the Chief Executive Officer. In March 2026, Dale Hooks was appointed Chief Commercial Officer to support the planned BLA submission and potential commercial launch of TA-ERT.