Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
Spruce Biosciences, Inc. (SPRB)
Company Research
Source: Business Wire
Based on FDA Feedback, Company Continues to Advance BLA Submission for TA-ERT Using CSF HS-NRE as Reasonably Likely Surrogate Endpoint for Accelerated ApprovalBLA Submission for TA-ERT is Now Anticipated in the Fourth Quarter to Accommodate Drug Product PPQ Requirement SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the successful completion of Type B meetings with the U.S. Food and Drug Administration (FDA or the Agency) regarding its planned upcoming biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy (TA-ERT).The company held two Type B meetings with the FDA ahead of its anticipated BLA submission for TA-ERT; the first in December 2025 to discuss the company’s clinical data and regulatory strategy, and the second in Januar
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News
- Spruce Biosciences to Participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference [Yahoo! Finance]Yahoo! Finance
- Spruce Biosciences to Participate in the Oppenheimer 36th Annual Healthcare Life Sciences ConferenceBusiness Wire
- Long-Term Data Presented at the 22nd Annual WORLDSymposium™ Highlights Tralesinidase Alfa Enzyme Replacement Therapy’s Potential as the First Disease-Modifying Treatment Option for Sanfilippo Syndrome Type B (MPS IIIB)Business Wire
- Spruce Biosciences Adds Regulatory and Clinical Development Expertise to Leadership Team [Yahoo! Finance]Yahoo! Finance
- Spruce Biosciences Adds Regulatory and Clinical Development Expertise to Leadership TeamBusiness Wire
SPRB
Sec Filings
- 2/18/26 - Form SCHEDULE
- 2/17/26 - Form SCHEDULE
- 2/17/26 - Form SCHEDULE
- SPRB's page on the SEC website