Caribou Biosciences Gets FDA Fast-Track Designation for Two Candidates

By Robb M. Stewart

Caribou Biosciences has received Food and Drug Administration fast-track designation for a pair of products under development.

The biopharmaceutical company said the designation, designed to expedite clinical development and regulatory review, has been granted for CB-010 for refractory systemic lupus erythematosus, and to CB-012 for relapsed or refractory acute myeloid leukemia.

CB-010, Caribou's lead clinical-stage product candidate from its allogeneic CAR-T cell-therapy platform, will be evaluated in a Phase 1 clinical trial in patients with lupus nephritis and extrarenal lupus, subcategories of systemic lupus erythematosus. The trial is on track to start by the end of the year, the company said.

CB-012 is being evaluated in the company's ongoing Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia.

In premarket trading, Caribou's shares were up 4.2% after ending last week at $2.16, down 62% so far this year.

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

(END) Dow Jones Newswires

September 03, 2024 08:39 ET (12:39 GMT)

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