Spruce Biosciences: TA-ERT için BLA başvurusu 2026'nın 4. çeyreği için planlandığı gibi ilerliyor

Following positive Type B meetings, FDA confirmed that integrated study data and natural history data could serve as an adequate and well-controlled study supporting accelerated approval via CSF heparan sulfate non-reducing end as a reasonably likely surrogate endpoint. The company reiterated its plan to submit the BLA for TA-ERT in the fourth quarter of 2026.

Temel olgular

Bildirildi: 20 Mar 2026 21:04
Olay: Başvuru yapıldı
Yön: Olumlu
Şirket: SPRBSpruce Biosciences
Varlık: tralesinidase alfa
Kaynak: SEC 8-K
Güvenilirlik: Kaynaklı

Kaynak alıntısı

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

SEC 8-K