Arcellx Inc ACLX shares are trading lower by 8.50% to $32.76 Tuesday morning after the FDA on Monday put a clinical hold on the company's multiple myeloma phase 2 trial.
On June 16, a clinical hold was placed after a patient death. Arcellx believes limitations on bridging therapy are a factor and is working with the FDA to expand patient options. Arcellx has FDA clearance to continue dosing lymphodepleted patients.
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Arcellx says it prioritizes patient safety and is collaborating with investigators, DSMB, and Kite Pharma to address the hold. They are confident in CART-ddBCMA as a potential leading therapy for rrMM. Manufacturing and enrollment are progressing well. They aim to resolve the issue quickly and advance the therapy for rrMM patients.
According to data from Benzinga Pro, ACLX has a 52-week high of $48.92 and a 52-week low of $14.85.
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