Cellectis Gains FDA Orphan Drug Status for ALL Therapy

Cellectis SA (CLLS) has released an update.

Cellectis SA, a clinical-stage biotech company, has been granted Orphan Drug Designation by the FDA for its investigational drug CLLS52, intended for the treatment of B-cell acute lymphoblastic leukemia (ALL). This designation could accelerate the drug’s development and commercialization, and highlights Cellectis’ innovation in combining gene-edited CAR T-cells with a lymphodepleting regimen to enhance clinical effectiveness. The company specializes in gene-editing technologies and CAR-T immunotherapies, aiming to deliver off-the-shelf solutions for cancer patients.

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