The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Beam Therapeutics’ BEAM Investigational New Drug (IND) application for the candidate BEAM-201 in the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL).
The regulatory agency has indicated that they will provide an official clinical hold letter to Beam within 30 days.
The Investigational New Drug (IND) application was submitted by the company in the month of June, 2022.
The company plans to provide additional updates pending discussion with the agency.
BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate.
Price Action : Beam Therapeutics shares are trading around 10 percent down on Monday during pre-market session.
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
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