Gilead Sciences has entered into a definitive agreement to acquire Arcellx for an equity value of $7.8 billion.  

Arcellx is a biotechnology company focused on delivering a new class of immunotherapies for patients with cancer and other incurable diseases. 

The companies have an existing collaboration to co-develop and co-commercialise Arcellx’s lead pipeline candidate, anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for patients with multiple myeloma. 

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile. 

The BLA for anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma is supported by results from the Phase I study (NCT04155749) and the pivotal Phase II iMMagine1 study (NCT05396885). It has been accepted by the US Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of 23 December 2026. 

“This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy. In addition, the anito-cel D-domain BCMA binder could be important to our work in in vivo cell therapy, further strengthening our potential in oncology and inflammation.” 

In addition to anito-cel, Arcellx’s D-Domain CAR technology platform has generated proprietary, target-binding domains with improved specificity and enhanced binding affinity that could potentially be used for next-generation CAR T-cell and bispecific therapies. There is potential to leverage the D‑domain BCMA binder in in vivo cell therapy efforts.