原始出處紀錄
重大申請已送件
Spruce Biosciences：TA-ERT BLA 提交按計劃於 2026 年第四季度進行
在與 FDA 舉行正面 Type B 會議後，FDA 確認整合干預性研究與自然史數據可作為支持加速批准的充分且控制良好的研究。公司現計劃於 2026 年第四季度提交 TA-ERT 的 BLA，並可能符合罕見兒科疾病優先審查憑證的資格。
關鍵事實
- 申報時間
- 2026年3月9日 上午11:23
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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