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Highlights
- The US FDA awarded Fast Track designation to clinical program studying VAXINIA in bile duct cancer.
- This designation enables enhanced collaboration with the FDA, facilitating the expedited progress of the MAST clinical program and potential approval process.
- The status grants eligibility for Accelerated Approval and Priority Review.
Shares of Imugene Limited (ASX: IMU) have been trading higher on 28 November 2023 as the company announced a key development.
The US Food and Drug Administration (FDA) has granted Fast Track designation to the company’s MAST (Metastatic Advanced Solid Tumours) clinical program, designed to assess the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA).
The company shares were noted trading at AU$0.105 at the time of writing, up more than 15% from the last close. In the last one month, the share price has appreciated by 180%.
What is Fast Track designation?
The FDA Fast Track designation is granted to facilitate easy access to new therapies for patients. It allows swift development as well as accelerates review of drug candidates for treating major health problems and meeting medical needs.
Imugene has been awarded the FDA Fast Track Designation on the basis of its data package that stated Phase 1 efficacy and tolerability data for bile duct cancer patients.
With this designation, IMU will be able to build better communication with the Food and Drug Administration for discussions relating drug development plans. It may also get a Rolling Review of its Biologic License Application and holds chance to be eligible for Accelerated Approval and Priority Review for VAXINIA in bile duct cancer.
Trial details (Data source: company update)