RegulatoryCompany release

Spruce Biosciences holds December BLA plan for MPS IIIB therapy, amends loan and spins off antibody unit

🇺🇸 Spruce Biosciences, Inc. (SPRB) · Mon 09 Nov 2026

The company still intends to seek FDA accelerated approval of tralesinidase alfa for MPS IIIB in December, while restructuring its debt and separating its CRHX-101 programme.

Spruce Biosciences said on 9 November, with its third-quarter 2026 results, that it remains on track to submit a Biologics License Application in December 2026. The filing would seek accelerated approval from the US Food and Drug Administration for TA-ERT (tralesinidase alfa) in mucopolysaccharidosis type IIIB (MPS IIIB). It would rest on a surrogate endpoint: cerebrospinal fluid heparan sulfate nonreducing end (CSF HS-NRE).

The company has also begun a US expanded access programme this month. It plans to start the TrAnsform confirmatory study in December. The FDA requested that study.

On 6 November Spruce amended its loan with Avenue. Tranche 2 availability rises to $15 million, and the interest-only period is extended. The summary does not give the new interest-only end date or other terms.

Spruce also moved its CRHX-101 antibody programme into a subsidiary, Adrenyx Biosciences. The subsidiary has issued $5 million under a convertible note facility of up to $10 million.

As general context, accelerated approval in the US allows a drug for a serious condition to be authorised on a surrogate endpoint considered reasonably likely to predict clinical benefit. Confirmatory evidence is then required after approval.

What it means for your team

  • Regulatory teams should watch for the December BLA submission and for any FDA decision on filing acceptance and the review pathway.
  • The reliance on CSF HS-NRE as a surrogate endpoint makes biomarker acceptability a central issue in the application.
  • The planned TrAnsform study and the expanded access programme are relevant to post-approval evidence generation and early patient access.
  • Market-access observers can note the extended financing runway and the separation of CRHX-101, which ring-fences that programme from the MPS IIIB filing.

Company's press release (SEC filing): Spruce Biosciences, Inc. ↗

Article written by VigiEye from the official source (Spruce Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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