Caribou Biosciences Gets FDA RMAT, Fast-Track Designations for CB-101

By Colin Kellaher

Caribou Biosciences Inc. on Tuesday said the U.S. Food and Drug Administration granted a pair of key designations to CB-101, the lead product candidate from the clinical-stage biopharmaceutical company's allogeneic CAR-T cell- therapy platform.

The Berkeley, Calif., company said the FDA granted CB-010 regenerative-medicine-advanced-therapy, or RMAT, designation for relapsed or refractory large B cell lymphoma and fast-track designation for relapsed or refractory B cell non-Hodgkin lymphoma.

The FDA's RMAT designation offers eligibility for expedited development and regulatory review of product candidates, including earlier and more frequent consultation with the agency, and the potential for accelerated approval, while the agency's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Caribou is currently studying CB-010 in an open-label, multicenter Phase 1 U.S. clinical trial in adults with relapsed or refractory B cell non-Hodgkin lymphoma.

Caribou shares, which closed Monday at $8.54, rose 4.8% to $8.95 in premarket trading Tuesday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 29, 2022 09:35 ET (14:35 GMT)

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