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%.
