Spruce Biosciences targets Q4 2026 BLA filing for TA-ERT in Sanfilippo syndrome type B after FDA meetings

• Spruce Biosciences reported positive pre-BLA meetings with the FDA for TA-ERT in Sanfilippo syndrome Type B.
• No new clinical trial results were presented; the update focused on regulatory alignment ahead of a planned BLA submission in Q4 2026.
• The FDA discussions supported Spruce’s plan to seek accelerated approval based on biomarker evidence intended to predict clinical benefit.
• Spruce expects to start a confirmatory study during the FDA’s review, positioning TA-ERT for a potential first disease-modifying launch if cleared.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Spruce Biosciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260824589114) on August 24, 2026, and is solely responsible for the information contained therein.