FDA CAR-T decision pending, Gilead buys Arcellx for $7.8B

Gilead Sciences has entered into a definitive agreement to acquire California biotech Arcellx, in a deal with an implied equity value of $7.8 billion, taking full ownership of anito-cel, an investigational BCMA-directed CAR-T cell therapy with a December 23, 2026 PDUFA date.

Arcellx formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed and/or refractory multiple myeloma with Gilead’s Kite in December 2022, expanding it a year later to include the license for Arcellx’s multiple myeloma program and propel treatment of lymphomas.

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, addressing key challenges associated with current CAR T-cell therapies in multiple myeloma. 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 1 study and the pivotal phase 2 iMMagine1 study

Anito-cel is the first BCMA-directed CAR-T cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. According to Arcellx, the small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity.