原始来源记录
重大申请已提交
Spruce Biosciences：MPS IIIB 的 TA-ERT BLA 计划于 2026 年 Q4 提交
该公司宣布，其针对 MPS IIIB 的 TA-ERT BLA 提交现预计于 2026 年 Q4 进行，拟基于 CSF HS-NRE 作为替代终点寻求加速批准。FDA 要求的 TrAnsform 确证性研究也预计于 2026 年 Q4 启动，与 BLA 审评同步进行，扩大使用计划将在同一季度启动。
关键事实
- 申报时间
- 2026年8月12日 13:05
- 事件
- 申请已提交
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 sprb-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Spruce Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates Biologics License Application (BLA) for TA-ERT for the Treatment of MPS IIIB Anticipated in the Fourth Quarter of 2026 TrAnsform Confirmatory Study Required for Potential FDA Accelerated Approval of TA-ERT Expected to Initiate in the Fourth Quarter of 2026 Strengthened Leadership Team with the Appointments of Adrian Quartel, M.D., FFPM, as Chief Medical Officer and Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development South San Francisco, Calif. — August 12, 2026 — Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological dis