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Allogene Therapeutics' Cemacabtagene Ansegedleucel Receives FDA RMAT, Fast Track Designations

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Allogene Therapeutics (ALLO) said Wednesday that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy, or RMAT, and Fast Track designations for cemacabtagene ansegedleucel, or cema-cel, to treat adult patients with large B-cell lymphoma.

The company said the drug is an investigational allogeneic CAR T product being studied in the pivotal ALPHA3 trial as a first-line consolidation treatment for patients with large B-cell lymphoma who are at high risk of relapse.

The investigational drug is intended for patients who, at the completion of first-line therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease.

"Together, the designations enable more frequent FDA engagement and support an efficient development and review process," the company said in a statement.

Shares of Allogene were up 3%.

Price: $1.71, Change: $+0.05, Percent Change: +2.77%

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