Spruce Biosciences reported $48.9 million in cash and cash equivalents as of December 31, 2025, excluding the $15.0 million initial tranche under its Avenue Capital loan. R&D expenses declined to $19.5 million from $46.4 million in 2024, G&A expenses rose to $17.0 million from $14.6 million, and net loss improved to $39.0 million from $53.0 million.

In February 2026 the company completed two Type B meetings with the FDA, which confirmed that its integrated clinical and natural history data may support an accelerated approval pathway for TA-ERT. Spruce intends to submit its biologics license application for TA-ERT in the fourth quarter of 2026, aiming to secure the first approved therapy for MPS IIIB.

In January 2026 Spruce entered a $50 million loan facility with Avenue Capital, featuring a fully funded $15 million initial tranche and up to $35 million in future tranches over a 42-month term. This capital is earmarked to advance TA-ERT development and support a potential commercial launch.

The company appointed Dale Hooks as Chief Commercial Officer to lead TA-ERT commercialization, and added Daven Mody as SVP of Regulatory and Quality, Bruno Gagnon as SVP of Clinical Development Operations, and Keli Walbert to its board, enhancing its commercial, regulatory and clinical expertise.