企業プロフィール
Spruce Biosciences 株価・ニュース・カタリスト
- ティッカー:
- SPRB
- 取引所:
- NASDAQ
- セクター:
- Biopharma
- 所在地:
- United States
株価パフォーマンス
44.77 USD (-7.84%)
終値
最終更新: 2026年10月1日
136M USD
時価総額
株価変動の要因
2026年10月1日 時点で SPRB は 7.84% 下落し、$44.77 で取引を終えました。現在のニュース監視期間内に同社の新しいニュースは確認されませんでした。
企業概要
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.
今後のカタリスト
- 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.
最近のニュース
ニュースタイトルは機械翻訳です。詳細は英語の原文をご覧ください。
類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。