This event is archived. Final snapshot from when the story concluded. View on Dashboard
Events / Regulatory / Cellectis lasme-cel receives FDA RMAT
Regulatory regulatory approval

Cellectis lasme-cel receives FDA RMAT

Analysis based on 6 articles · First reported Jun 09, 2026 · Last updated Jun 09, 2026

Sentiment
70
Attention
4
Articles
6
Market Impact
General
Live prominence charts, article sentiment distribution, and event development timeline available on the Ergen Dashboard
Market Impact

The RMAT designation for Cellectis>>>'s lasme-cel is a significant positive for the biotechnology sector, particularly for companies developing cell and gene therapies. This designation could accelerate the development and regulatory review process, potentially bringing a new treatment option to market faster and increasing investor confidence in Cellectis>>>'s stock.

biotechnology pharmaceuticals
Event Summary

Cellectis>>>, a clinical-stage biotechnology company, announced that the United States — Food and Drug Administration>>> granted Regenerative Medicine Advanced Therapy (RMAT) designation to its CD22-targeting allogeneic CAR-T cell therapy product candidate, lasmecabtagene timgedleucel (lasme-cel). This designation is for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The RMAT designation acknowledges the potential of lasme-cel to address a significant unmet medical need, supported by promising efficacy and a manageable safety profile from Phase 1 BALLI-01 data. André Choulika>>>, Co-founder and CEO of Cellectis>>>, highlighted the importance of this recognition for off-the-shelf CAR-T options. Final Phase 1 data will be presented by Nitin Jain>>> at the 2026 Congress of the European Hematology Association>>>. The BALLI-01 trial's Pivotal Phase 2 is currently open for enrollment.

Entities Involved
stock
Cellectis
Cellectis received Regenerative Medicine Advanced Therapy (RMAT) designation from the United States — Food and Drug Administration>>> for its product candidate, lasme-cel, which is a significant positive development for the company's clinical program and market position.
Importance 100.0 Sentiment 75.0
govactor
United States — Food and Drug Administration
The United States — Food and Drug Administration>>> granted RMAT designation to Cellectis>>>'s lasme-cel, recognizing its potential to address unmet medical needs for patients with r/r B-ALL.
Importance 90.0 Sentiment 0.0
per
André Choulika
André Choulika, Co-founder and CEO of Cellectis>>>, commented on the significance of the RMAT designation for Cellectis>>>'s pioneering work in allogeneic CAR-T therapies.
Importance 60.0 Sentiment 0.0
per
Nitin Jain
Nitin Jain, a Professor of Medicine at MD Anderson Cancer Center, will present final Phase 1 data from the BALLI-01 trial of lasme-cel at the 2026 Congress of the European Hematology Association.
Importance 30.0 Sentiment 0.0
ngo
European Hematology Association
The European Hematology Association>>> will host its 2026 Congress where final Phase 1 data for lasme-cel will be presented.
Importance 10.0 Sentiment 0.0
ERGEN INTELLIGENCE
Track this event live

Set up alerts, explore entity relationships, search across thousands of events, and build custom intelligence feeds.

Open Dashboard

About Ergen

Ergen is a news intelligence platform that converts raw news articles into structured data. It tracks events, entities, and the relationships between them, with sentiment and attention metrics derived from thousands of articles. Pages on this site are daily static snapshots from the platform's live database. For real-time tracking, search, and alerts, the full dashboard is at app.ergen.ai.