Spruce Biosciences Reports Full Year 2025 Financial Results

Biopharmaceutical company provides updates on TA-ERT program for MPS IIIB

Published on Mar. 9, 2026

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Spruce Biosciences, a late-stage biopharmaceutical company, has reported its financial results for the year ended December 31, 2025 and provided corporate updates. The company's focus is on developing and commercializing novel therapies for neurological disorders, with a key program being TA-ERT for the treatment of MPS IIIB, a rare genetic disorder. Spruce announced positive interactions with the FDA, the appointment of a new Chief Commercial Officer, and securing growth capital to support the advancement and potential commercial launch of TA-ERT.

Why it matters

Spruce's TA-ERT program represents a potential first disease-modifying treatment option for patients with MPS IIIB, a devastating neurological disorder that currently has no approved therapies. The company's progress in advancing TA-ERT through the regulatory process and building its commercial capabilities is significant, as it aims to bring this much-needed therapy to market.

The details

Spruce reported that it held positive Type B meetings with the FDA regarding its planned BLA submission for TA-ERT in the fourth quarter of 2026. The FDA confirmed that the integrated study data could potentially serve as an adequate and well-controlled study to support an accelerated approval. The company also appointed Dale Hooks as Chief Commercial Officer and secured up to $50 million in growth capital from Avenue Capital to support the continued advancement and potential commercial launch of TA-ERT.

  • In February 2026, Spruce announced the successful completion of two Type B meetings with the FDA regarding its planned BLA submission for TA-ERT.
  • The BLA submission for TA-ERT is anticipated in the fourth quarter of 2026.
  • In January 2026, Spruce entered into a loan facility for up to $50 million in growth capital to support the continued advancement and potential commercial launch of TA-ERT.
  • In February 2026, data from two different analyses were presented at the 22nd Annual WORLDSymposium™, highlighting TA-ERT as potentially the first disease-modifying treatment option for MPS IIIB.
  • In February 2026, the Rare Pediatric Disease Priority Review Voucher (PRV) program was reauthorized through September 30, 2029, which allows companies to receive a fast-track review voucher for approved drugs.

The players

Spruce Biosciences, Inc.

A late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need.

Javier Szwarcberg, M.D., M.P.H.

Chief Executive Officer of Spruce Biosciences.

Dale Hooks

An accomplished rare disease commercial leader who was appointed as Chief Commercial Officer of Spruce Biosciences.

Daven Mody, Pharm.D.

Appointed as Senior Vice President, Regulatory and Quality at Spruce Biosciences.

Bruno Gagnon, B.Pharm., M.Sc.

Appointed as Senior Vice President, Clinical Development Operations at Spruce Biosciences.

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What they’re saying

“2025 was a very productive year, and our team continues to execute and drive towards key milestones with our tralesinidase alfa enzyme replacement therapy (TA-ERT) program, especially our planned biologics license application (BLA) submission in the fourth quarter of this year and potential commercial launch in MPS IIIB.”

— Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences (businesswire.com)

What’s next

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

Spruce Biosciences' progress in advancing its TA-ERT program for the treatment of MPS IIIB, a rare neurological disorder, represents a significant step forward in addressing an unmet medical need. The company's efforts to secure regulatory approval, build commercial capabilities, and secure funding demonstrate its commitment to bringing this potential first disease-modifying therapy to patients.