Shares of Arcellx, Inc. (NASDAQ: ACLX) took a nosedive in pre-market trading on Tuesday, dropping by a staggering 16.82%. The sharp decline comes in the wake of a significant setback for the company’s iMMagine-1 Phase 2 clinical program.
Arcellx (ACLX) received distressing news from the U.S. Food and Drug Administration (FDA) regarding its investigational new drug (IND) called CART-ddBCMA. This treatment aims to help patients with relapsed or refractory multiple myeloma (rrMM).
On June 16, Arcellx was informed that the FDA had imposed a clinical hold on the CART-ddBCMA IND. This decision followed the unfortunate death of a patient involved in the study. The company is currently investigating whether limitations on bridging therapy played a role in this tragic event.
In response, Arcellx is actively collaborating with the FDA to modify the protocol and provide expanded treatment options for patients. The goal is to align the study with the latest clinical practices. Encouragingly, the FDA has granted Arcellx clearance to continue administering doses to patients who have undergone lymphodepletion.