PDUFAApproval decision

Anito-cel (anitocabtagene autoleucel)(CART-ddBCMA)

Multiple myeloma

ACLXArcellx Inc

Expected catalystDecember 23, 2026Company guidance: Dec 23, 2026

Catalyst overview

Event details

Drug or asset: Anito-cel (anitocabtagene autoleucel)(CART-ddBCMA)
Development stage: PDUFA
Event type: Approval decision
Indication: Multiple myeloma

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Anito-cel (anitocabtagene autoleucel)(CART-ddBCMA) in Multiple myeloma. The expected timing is based on the latest available company guidance and may change.

Development notes

iMMagine-1 trial. Collab w/ Kite. 6/14/25- Presented new data at EHA'25. 12/6/25- Presented data at ASH'25. 02/23/26:- FDA accepted BLA for anito-cel; PDUFA action date December 23, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source