Spruce Biosciences (SPRB) News Today

Spruce Biosciences, Inc. (NASDAQ: SPRB) shares have risen sharply on FDA Breakthrough Therapy Designation for its lead tralesinidase alfa enzyme replacement therapy (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB), setting the stage for a potential rolling BLA submission, Priority Review and Accelerated Approval pathway.

• Positive Sentiment: The FDA awarded Breakthrough Therapy Designation to TA-ERT for MPS IIIB, backed by robust 5-year biomarker and clinical data, enabling an expedited development and review pathway.Business Wire: BTD Announcement
• Positive Sentiment: Company plans to file a BLA for TA-ERT in Q1 2026, aiming to deliver the first disease-modifying therapy for MPS IIIB patients.Seeking Alpha: BLA Submission Outlook
• Positive Sentiment: Shares hit a 52-week high amid widespread coverage of the FDA designation and analysts raising price targets, including one setting a $131.25 target.MarketWatch: 52-Week High Analyst Price Target
• Positive Sentiment: Media outlets report a roughly 1,300–1,600% intraday jump on the FDA news, driving trading volume well above its average.IBTimes: 1,300% Jump
• Neutral Sentiment: Spruce is highlighted among seven small-cap stocks to watch by MarketBeat’s stock screener, reflecting increased investor interest in its sector.MarketBeat: Small Cap Stocks
• Neutral Sentiment: A series of Limit Up/Limit Down (LULD) trading halts occurred due to extreme volatility, underscoring rapid share-price swings but not indicating fundamental issues.