Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus

Sana Biotechnology

2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025.

Sana Biotechnology today announced that the US FDA granted fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus, which includes extra-renal lupus and lupus nephritis.

Read Sana Biotechnology press release

Michael Wonder

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Michael Wonder

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US , Cellular therapy , Fast track