原始来源记录
重大申请已提交
Spruce Biosciences：TA-ERT BLA 提交计划按 Q4 2026 推进
在与 FDA 举行积极的 B 类会议后，FDA 确认整合研究数据和自然病史数据可作为充分且对照良好的研究，支持通过 CSF 硫酸乙酰肝素非还原端作为合理可能的替代终点加速批准。公司重申计划于 2026 年第四季度提交 TA-ERT 的 BLA。
关键事实
- 申报时间
- 2026年3月20日 21:04
- 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 Full Year 2025 Financial Results and Provides Corporate Updates Following Positive Type B Meetings with the FDA, BLA Submission for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) on Track for the Fourth Quarter of 2026 Appoints Dale Hooks as Chief Commercial Officer, Strengthening the Company’s Commercial Capabilities in Preparation for a Potential Launch of TA-ERT Secured up to $50 Million in Growth Capital from Avenue Capital Group South San Francisco, Calif. – March 9, 2026 – 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