Cellectis: FDA designates alemtuzumab an orphan drug

(CercleFinance.com) - Cellectis announced Thursday evening that alemtuzumab, an experimental treatment for leukemia, had been granted orphan drug designation by U.
S. health authorities.

The Food and Drug Administration (FDA) granted this status to CLLS52 (alemtuzumab), a drug candidate used as part of the lymphodepletion regimen associated with UCART22, another Cellectis candidate being evaluated in a clinical trial in relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

In a press release, Cellectis explains that the addition of this lymphodepleting agent was associated with sustained lymphodepletion, enabling greater clinical activity.

The FDA grants orphan drug status to drugs intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

In particular, this designation could enable the French laboratory to obtain an accelerated regulatory process, reduce its development costs, and reach product approval more quickly.

Despite this good news, Cellectis shares were down 0.7% on Friday on the Paris Bourse, but still posted a gain of over 17% over the past month.

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