Arcellx drops 23% as FDA issues clinical hold on multiple myeloma candidate
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Cell therapy developer Arcellx, Inc. (NASDAQ:ACLX) lost ~23% in the pre-market trading Tuesday after announcing that the FDA placed a clinical hold on its Phase 2 iMMagine-1 trial for multiple myeloma candidate CART-ddBCMA.
FDA notified on June 16 that CART-ddBCMA targeted at relapsed or refractory multiple myeloma had been placed on clinical hold, ACLX noted, adding that the company is working with partner Kite Pharma of Gilead (NASDAQ:GILD) to resolve the issue.

The company assumes that the clinical hold could be due to limitations on bridging therapy and is working with the FDA to amend the trial protocol.
Despite the hold, the FDA has permitted Arcellx (ACLX) to proceed with the dosing in patients who have undergone lymphodepletion. The iMMagine-1 trial continues in 14 sites, with its enrollments on track to meet the companyâs expectations. 


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