Spruce Biosciences:TA-ERTのBLA提出は2026年第4四半期に向けて予定通り進行

Following positive Type B meetings, the FDA confirmed that integrated interventional and natural history data could serve as an adequate and well-controlled study supporting accelerated approval. The company now plans to submit the BLA for TA-ERT in Q4 2026, with potential eligibility for a Rare Pediatric Disease Priority Review Voucher.

主要事実

提出: 2026年3月9日 11:23
イベント: 申請提出
方向: 中立
企業: SPRBSpruce Bio
アセット: tralesinidase alfa
出典: SEC 8-K
信頼度: 出典あり

出典の抜粋

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

SEC 8-K