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 确认整合的干预性数据和自然史数据可作为支持加速批准的充分且对照良好的研究。公司现计划于 2026 年第四季度提交 TA-ERT 的 BLA，并可能获得罕见儿科疾病优先审评凭证的资格。
关键事实
- 申报时间
- 2026年3月9日 11:23
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 6 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