Gilead Sciences has agreed to acquire Arcellx for an implied equity value of $7.8bn.
Kite, a Gilead company, and Arcellx are working together 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.
Arcellx is a biotechnology company working to develop a new class of innovative immunotherapies for patients with cancer and other incurable diseases.
Despite advancements in treatment, many patients with multiple myeloma eventually relapse and require additional treatment. As disease progresses, patients often experience diminishing responses, increasing toxicity and fewer viable options, especially those who are heavily pretreated or unable to tolerate existing therapies.
The Biologics License Application (BLA) is for the use of anito-cel as a fourth-line treatment for patients with relapsed or refractory multiple myeloma. It is supported by results from the phase 1 study and the pivotal phase 2 iMMagine1 study.
In clinical studies to date, anito-cel has demonstrated positive responses with a manageable safety profile. The BLA has been accepted by the US FDA, with its review expected by 23 December 2026.
Daniel O’Day, Chairman and Chief Executive Officer at Gilead Sciences, said: “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.
“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 vivo cell therapy efforts.
Rami Elghandour, Chairman and Chief Executive Officer at Arcellx, said: “The story of Arcellx is one of innovation, passion, resilience and teamwork. We are fortunate to have found a world-class partner in Gilead, which has the expertise to carry forward Arcellx’s legacy. Kite is well-positioned to maximise access to anito-cel, benefiting more patients.”
The deal is expected to close during the second quarter of 2026.