Cellectis S.A.: Lasme-cel Granted FDA RMAT Designation, An Incremental Positive In Our View

Research evidence excerpt

Cellectis S.A.: Lasme-cel Granted FDA RMAT Designation, An Incremental Positive In Our View

Equity Research

U.S. Small & Mid Cap Biotechnology

9 June 2026

Cellectis S.A.

Lasme-cel Granted FDA RMAT

Designation, An Incremental First Look

CLLS OVERWEIGHTPositive In Our View

U.S. Small & Mid Cap POSITIVE

RMAT designation allows for potential accelerated approval Biotechnology Price Target USD 9.00

and priority review timelines, which could be supported by Price (09-Jun-26) USD 2.99

the ongoing pivotal trial in B-ALL. Potential Upside/Downside +201.0% Source: Bloomberg, Barclays Research

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CLLS announced via press release that FDA has granted Lasme-cel (CD22 allogenic CAR-T)

Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of patients with

relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The designation is supported

by data from the Phase 1 BALLI-01 trial where patients in the Phase 2 target population

achieved an ORR of 100% and all patients were eligible or had moved on to receive stem cell

transplant. Final Phase 1 data from BALLI-01 will be presented in an oral presentation at the

European Hematology Association (EHA) congress this Saturday.

RMAT designation allows for potential accelerated approval

The FDA RMAT designation allows for potential accelerated approval for Lasme-cel based on

data from the ongoing pivotal Phase 2 trial in relapsed/refractory B-ALL patients. RMAT allows