Autolus publishes UK Annual Report; provides obe-cel BLA status, PDUFA date Nov 16, 2024

Autolus Therapeutics plc

BLA for obe-cel accepted by FDA; PDUFA target action date set for 16 November 2024.
Phase 2 FELIX study data: 78% CR/CRi rate in evaluable r/r adult B-ALL patients; median follow-up 16.6 months.
First two patients enrolled in CARLYSLE Phase 1 trial of obe-cel for SLE; initial data expected by end of 2024.
In Phase 1 ALLCAR19 trial, 41% of patients in ongoing remission at 3-year median follow-up without transplant.
AUTO1/22 dual-targeting CAR T showed 83% MRD-negative complete remission in paediatric r/r B-ALL.

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