Cellectis S.A. (CLLS), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration, or FDA, has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its CAR-T cell therapy candidate Lasmecabtagene timgedleucel, also known as "lasme-cel," for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer caused by the uncontrolled proliferation of immature B-cell lymphoblasts. When lymphoblastic leukemia cells fail to respond to treatment and do not achieve remission, it leads to relapsed or refractory B-ALL. (Source: clevelandclinic)
Lasmecabtagene timgedleucel, or lasme-cel, is an allogeneic CAR-T cell product that targets CD-22 and is currently being evaluated for r/r B-ALL treatment in Cellectis' pivotal phase 2 trial dubbed BALLI-01. The first interim results of the phase 2 trial are expected in the fourth quarter of 2026.
The RMAT designation is supported by encouraging results from Phase 1, dubbed BALLI-01 data, that demonstrated a manageable safety profile and promising efficacy. Additionally, the company noted it will present the final phase 1 data from BALLI-01 of lasme-cel at the Congress of the European Hematology Association (EHA) held on June 13, 2026.
Cellectis has traded between $1.3270 and $5.4800 over the last year.
Cellectis shares closed Tuesday at $2.99, up 2.05%. In the overnight market the shares are trading at $3.08, up 3.01%.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.