Imugene Ltd (ASX: IMU) shares are on the move on Wednesday and avoiding the market weakness after the clinical-stage immuno-oncology company announced a major regulatory milestone in the United States.
At the time of writing, the ASX stock is up 11% to 3.9 cents.
This compares favourably to a 0.4% decline by the All Ordinaries index in early trade.
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Why is this ASX stock surging?
Investors have been buying Imugene shares after it revealed that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA's Fast Track Designation is an important regulatory pathway designed to accelerate the development and review of promising therapies that target serious or life-threatening conditions and meet an unmet medical need.
For Imugene, this designation brings several benefits. This includes more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review if key criteria are met.
What is azer-cel?
Azer-cel is an off-the-shelf CAR T-cell therapy designed to overcome the logistical challenges of traditional autologous CAR T treatments.
The company notes that unlike conventional CAR T therapies, which require a patient's own cells to be collected and modified—a process that can take weeks—azer-cel leverages pre-manufactured donor T-cells for rapid treatment delivery.
Clinical data from an ongoing Phase 1b trial has been promising, particularly in patients who have exhausted multiple prior treatment options.
A critical unmet need
The ASX stock highlights that DLBCL is the most common and aggressive form of non-Hodgkin's lymphoma, and many patients experience relapse or resistance to current treatments. Azer-cel offers a potential breakthrough for these patients by delivering a more accessible and effective alternative to existing therapies.
The ASX stock's managing director and CEO, Leslie Chong, was very pleased with the news. Commenting on today's development, Chong said:
Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL. We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible.
Despite today's gain, the Imugene share price is still down materially on a 12-month basis. Since this time last year, its shares have lost approximately 64% of their value.
