Gilead Sciences, Inc.
PDUFA Confirmed
anito-cel
multiple myeloma
Countdown
169days
FDA decision · Dec 23, 2026
What's at stake The FDA's approval decision on anito-cel for multiple myeloma is due Dec 23, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“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 (NCT04155749) and the pivotal Phase 2 iMMagine1 study (NCT05396885) and has been accep”

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