Imugene (ASX:IMU) obtained fast track designation from the US Food and Drug Administration for azer-cel, a potential treatment for relapsed or refractory diffuse large B-cell lymphoma, according to a Wednesday filing with the Australian bourse.
Azer-cel is in phase 1b clinical trial, per the filing.
The designation will enable the clinical-stage immuno-oncology company to have more frequent meetings with the US FDA for development plans, the option for a rolling review of regulatory submissions, and potential eligibility for accelerated approval and priority review once relevant criteria are met, the filing stated.
The company's shares surged almost 6% in recent Wednesday trade.
Price (AUD): $0.04, Change: $+0.0020, Percent Change: +5.71%
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