公司资料
Spruce Biosciences 股价、新闻与催化剂
- 股票代码:
- SPRB
- 交易所:
- NASDAQ
- 行业:
- Biopharma
- 所在地:
- United States
股票表现
44.77 USD (-7.84%)
收盘价
最后更新: 2026年10月1日
136M USD
市值
股价为何变动
截至 2026年10月1日，SPRB 下跌 7.84%，收于 $44.77。当前新闻监测窗口内未发现新的同公司新闻。
公司概览
Rare Neurological Disease Company
Spruce Biosciences is developing therapies for serious neurological disorders with high unmet need. Its current strategy is centered on a potential disease-modifying treatment for Sanfilippo syndrome type B.
Tralesinidase Alfa Enzyme Replacement Therapy
Tralesinidase alfa is a recombinant NAGLU enzyme replacement therapy delivered into the cerebrospinal fluid. It is designed to clear accumulated heparan sulfate from the central nervous system in children with MPS IIIB.
Long-Term Clinical Evidence
The clinical package includes years of treatment experience showing sustained biomarker normalization and preservation of cognitive, communication, and motor outcomes relative to natural-history patients. The FDA has recognized the cerebrospinal-fluid biomarker as reasonably likely to predict clinical benefit.
Accelerated-Approval Strategy
Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations support an expedited regulatory pathway. Spruce is preparing a BLA based on the integrated clinical dataset and plans a confirmatory study to support full approval.
Commercial Readiness for a Rare Disease Launch
The company is building medical, market-access, and commercial capabilities for a concentrated pediatric rare-disease population. An expanded-access program is intended to make treatment available to additional eligible patients before a potential approval.
Confirmatory Evidence Plan
Spruce plans a post-approval confirmatory study to verify clinical benefit while continuing collection of long-term natural-history and treated-patient data. This work is central to converting a potential accelerated approval into full approval.
未来催化剂
- Submission of the BLA for tralesinidase alfa in the fourth quarter of 2026.
- Initiation of the tralesinidase alfa expanded-access program in the fourth quarter of 2026.
近期新闻
新闻标题由机器翻译，详情为英文原文。
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