Spruce Biosciences Receives U.S. FDA Breakthrough Therapy Designation for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB) [Yahoo! Finance]
Spruce Biosciences, Inc. (SPRB)
Company Research
Source: Yahoo! Finance
U.S. FDA Confirmed that CSF HS-NRE is a Surrogate Biomarker Reasonably Likely to Predict Clinical Benefit and Could Serve as Basis for Accelerated Approval Biologics License Application Submission of TA-ERT for MPS IIIB Remains on Track for the First Quarter of 2026 SOUTH SAN FRANCISCO, Calif., October 06, 2025 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 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB). "We are pleased to receive U.S. FDA Breakthrough Therapy Designation as we prepare to submit the Biologics License Application of TA-ERT for the treatment of MPS IIIB in the first quarter of 2026. This designation highlights T
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News
- Spruce Biosciences (NASDAQ:SPRB) was upgraded by analysts at Leerink Partnrs from a "hold" rating to a "strong-buy" rating.MarketBeat
- Spruce Biosciences (NASDAQ:SPRB) was upgraded by analysts at Leerink Partners from a "market perform" rating to an "outperform" rating. They now have a $160.00 price target on the stock.MarketBeat
- Spruce Biosciences (NASDAQ:SPRB) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Spruce Biosciences (NASDAQ:SPRB) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=SPRB&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreetMarketBeat
- Spruce Biosciences (NASDAQ:SPRB) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
SPRB
Sec Filings
- 11/28/25 - Form EFFECT
- 11/28/25 - Form EFFECT
- 11/24/25 - Form SCHEDULE
- SPRB's page on the SEC website