FDA Grants RMAT Designation to Cellectis's Lead CAR-T Therapy lasme-cel for r/r B-ALL
CLLS has more than doubled off its 52-week low of $1.327.
Summary
Cellectis's lead allogeneic CAR-T therapy, lasme-cel, received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This marks the first allogeneic CAR-T in a pivotal trial to achieve this status, signaling the FDA's recognition of its potential to address a critical unmet medical need. The RMAT designation is a significant positive for the clinical-stage biotech, as it can accelerate the development and regulatory review process, potentially speeding up market access. This news follows a 6-K filing earlier today and precedes the presentation of final Phase 1 data for lasme-cel at the EHA Congress on June 13.
At the time of this announcement, CLLS was trading at $3.33 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $217.9M. The 52-week trading range was $1.33 to $5.48. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.