Sana Biotechnology (SANA) said Monday that the US Food and Drug Administration has granted fast track designation to its SC291 CAR T cell therapy product candidate for the treatment of relapsed/refractory systemic lupus erythematosus.
The company said the designation is designed to facilitate the development and expedite the regulatory review process of drugs that have the potential to treat serious conditions and "fill an unmet medical need."
Sana said it is enrolling patients for SC291's GLEAM trial and it expects to release initial data from the trial in 2025.
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