Arcellx's Lead Product Candidate Hit By FDA Clinical Hold For Multiple Myeloma, Stock Falls

The FDA has put a clinical hold on Arcellx Inc's ACLX iMMagine-1 Phase 2 clinical program for CART-ddBCMA investigational new drug for relapsed or refractory multiple myeloma. 

Arcellx's lead product candidate, CART-ddBCMA, has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the FDA.

The clinical hold was received on June 16 following a recent patient death. The company believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients consistent with current clinical practice.

The FDA has provided clearance to Arcellx to continue to dose patients who have undergone lymphodepletion.

In December 2022, Kite, a Gilead Sciences Inc GILD company, announced a global strategic collaboration to co-develop and co-commercialize Arcellx's CART-ddBCMA for relapsed or refractory multiple myeloma. 

Kite and Arcellx will jointly advance the CART-ddBCMA asset.

Arcellx will receive an upfront payment of $225 million, a $100 million equity investment, and other potential contingent payments. 

Last week, 2seventy Bio Inc TSVT announced that the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML), has been paused by Seattle Children's, the company's partner and the regulatory sponsor of the study, after a patient death. 

Price Action: ACLX shares are down 13.70% at $30.90 during the premarket session on the last check Tuesday.