Anito-cel (anitocabtagene autoleucel)
BLA accepted by the FDA; action date December 23, 2026. Gilead completed the Arcellx acquisition on April 28, 2026.
What it is
Anito-cel is a BCMA-directed CAR T-cell therapy for multiple myeloma, developed by Arcellx and Kite. The BLA covers fourth-line treatment of relapsed or refractory multiple myeloma. Gilead acquired Arcellx for about $7.8 billion, paying $115 per share in cash plus a $5 per share contingent value right, and now owns the product outright.↗ source
Why it matters to the stock. This is the largest pending FDA decision in Gilead's cell therapy business. The contingent value right pays only if cumulative global anito-cel net sales reach $6.0 billion from launch through 2029.
News
Gilead completes Arcellx acquisition ahead of anito-cel launch
Gilead completed its acquisition of Arcellx on April 28, 2026, so it now owns anito-cel outright.
Gilead agrees to buy Arcellx for $115 per share in cash plus CVR, about $7.8 billion
Gilead agreed to acquire the rest of Arcellx, the partner on anito-cel, a BCMA-directed CAR T-cell therapy for multiple myeloma.