Sana Biotechnology Gets FDA Fast Track Designation for SC291 Cell Therapy

Dow Jones12-02

By Robb M. Stewart

Sana Biotechnology has been granted fast track designation to accelerate development of its proposed treatment for relapsed and refractory systemic lupus erythematosus.

The U.S. Food and Drug Administration gave SC291, a CD19-directed allogeneic CAR T cell therapy developed using Sana's hypoimmune platform, fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

C291 is being evaluated in a trial of patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus and antineutrophil cytoplasmic antibody-associated vasculitis. Sana is enrolling patients in the study and said it expects to share initial data in 2025.

In premarket trading Monday, Sana's shares rose 1.1% after ending last week at $2.78, down 32% so far this year.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

December 02, 2024 09:29 ET (14:29 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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