InvestSMART

Imugene Limited (ASX:IMU)

ALERT: Price-sensitive ASX Announcement for IMU
Current share price for IMU : $0.053 -0.038 (-41.44%)+
Announcement
Release
9 Jun 2026 10:50AM
Price at Release
$0.091
Full Release
download
Summary
Imugene Limited announced that the US FDA has granted Fast Track Designation to their azer-cel (azercabtagene zapreleucel) for the treatment of relapsed or refractory Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma (CLL/SLL) and Marginal Zone Lymphoma (MZL). This designation facilitates the expedited development and review of azer-cel, which has shown significant clinical activity, achieving a 100% overall response rate (ORR) in the CAR T-naive CLL/SLL cohort and an 83% ORR in MZL, including four complete responses. Azer-cel, an off-the-shelf, CD19-directed CAR T-cell therapy, represents a promising approach for patients who have exhausted standard treatment options. The Fast Track Designation will enable more frequent engagement with the FDA and potential eligibility for Accelerated Approval and Priority Review, thereby supporting the advancement of Imugene's program.
Key Points
  • FDA grants Fast Track Designation to azer-cel for CLL/SLL and MZL.
  • Fast Track Designation aids in expedited drug development and review.
  • Azer-cel demonstrates 100% ORR in CLL/SLL and 83% ORR in MZL.
  • Enhanced FDA engagement and eligibility for Accelerated Approval and Priority Review.
  • Azer-cel is an off-the-shelf, CD19-directed CAR T-cell therapy.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.