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Beam Therapeutics Says FDA Puts BEAM-201 IND Application On Clinical Hold

Biotechnology company Beam Therapeutics Inc. (BEAM) announced that on Friday, July 29, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold.

BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June.

The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA.

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