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

研报英文原文证据摘录

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

Lukas Shumway, PhD

+1 212 526 7293

THE EXTEL SURVEY IS CLOSING SOON lukas.shumway@barclays.com

BCI, US

Support our industry-leading Etzer Darout, PhD, MBA

+1 212 526 6940 analysts with 5-Star votes in

etzer.darout@barclays.com

BCI, US the 2026 Extel All-America

Research Survey.

Vote Now View Analysts

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