Arcellx falls on news of FDA clinical hold

The US Food and Drug Administration (FDA) has slapped a clinical hold on US biotech Arcellx’ (Nasdaq: ACLX) CART-ddBCMA investigational new drug (IND) for the treatment of patients with relapsed or refractory multiple myeloma (rrMM).

Arcellx, which is reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, saw its shares fall 8.5% to $32.74 by mid-morning today, the first Nasdaq trading since its announcement.

The clinical hold was received on June 16, following a recent patient death, the company explained. Arcellx believes limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. The FDA has provided clearance to Arcellx to continue to dose patients who have undergone lymphodepletion.