ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA decision on Anito‑cel for multiple myeloma set for Dec 23 2026
The FDA’s target decision date for Gilead’s Anito‑cel CAR‑T therapy in relapsed/refractory multiple myeloma is Dec 23 2026. Follow updates on OdinSignal.
At a glance
- Date
- 2026-12-23
The U.S. Food and Drug Administration has a PDUFA target date of 23 December 2026 for anitocabtagene autoleucel (Anito‑cel), Gilead Sciences’ BCMA‑directed CAR‑T therapy for relapsed or refractory multiple myeloma in the fourth‑line setting. The agency’s calendar lists the drug as due to decide on that day, though the decision could be made earlier or extended beyond the goal date. [[PDUFA calendar](https://www.pdufa.bio/fda-this-month)\]
This date marks the next regulatory milestone for a therapy that could expand options for patients with limited treatment alternatives. Stakeholders can track the outcome through the FDA’s official records and the dedicated OdinSignal page.
FOLLOW THE EVENT
What happens next?
Explore the event, review its rules, and share your prediction on OdinSignal.
Explore the prediction market →Virtual credits only. No cash value.More from the Journal
Summit Therapeutics’ ivonescimab receives FDA PDUFA goal date of Nov 14 2026
Summit Therapeutics’ ivonescimab (HARMONi) BLA has a FDA PDUFA goal action date of November 14 2026 for non‑small cell lung cancer.
Read article →OPEC to Hold 42nd Ministerial Meeting on 29 November 2026
OPEC and non‑OPEC participating countries will convene on 29 Nov 2026 for the 42nd Ministerial Meeting, reaffirming the current crude‑oil production framework.
Read article →U2’s 16th Studio Album ‘Carnaval De Luz’ Set for November 13, 2026 Release
Island Records confirms U2’s new album ‘Carnaval De Luz’ will drop on November 13, 2026, marking their first studio album of new material in nine years.
Read article →Prediction markets express uncertainty, not established outcomes. OdinSignal uses virtual credits with no cash value.