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.
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.