regulatory
confidence high
sentiment negative
materiality 0.85
FDA places clinical hold on Beam's BEAM-201 IND for T-ALL/T-LL
Beam Therapeutics Inc.
- FDA clinical hold on BEAM-201 IND for relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
- Beam informed via FDA email on July 29, 2022; IND submitted end of June.
- BEAM-201 is an anti-CD7, multiplex-edited allogeneic CAR-T candidate.
- FDA to provide official clinical hold letter within 30 days; Beam plans updates after discussions.