GILD · Earnings call · 2026Q3T · Full report

Cell Therapy Manufacturing and Expansion

GILEAD SCIENCES, INC. · 2026-10-29 · Importance 31 · Surprise 24

Gilead is expanding its cell-therapy pipeline beyond multiple myeloma, including KITE-512, a GPC-3-targeted CAR T therapy for advanced hepatocellular carcinoma. The company has begun dosing an investigator-initiated in vivo BCMA CAR-T trial in China in collaboration with Pregene, leveraging Kite’s manufacturing capabilities. Management said PALISADES-1 and -2, which evaluate KITE-753 in diffuse large B-cell lymphoma, were placed on a partial clinical hold while safety differences between Phase 1 and Phase 2 are investigated. Kite described its rapid manufacturing process for that program as three days, distinct from the one-day process used by some competitors.

Key facts

• Gilead's KITE-753 PALISADES-1 and 2 trials were on partial clinical hold while the company investigated safety differences between Phase 1 and Phase 2.
• Gilead's PALISADES program used a 3-day rapid manufacturing process, and the company paused to investigate Grade 3 and Grade 4 ICANS in a small number of patients; there had been no patient deaths or Grade 5 cases.
• Gilead had a December 23, 2026 PDUFA date for anito-cel and targeted activation of 80% of its Authorized Treatment Centers within the first 6 months after launch.
• Gilead said KITE-363's autoimmune program did not use rapid manufacturing and its rheumatology and neurology Phase 1 trials were expected to continue.