Imugene Gains FDA Orphan Status for Cancer Therapy

Imugene Limited (AU:IMU) has released an update.

Imugene Limited has been granted Orphan Drug Designation by the U.S. FDA for their novel treatment, VAXINIA, aimed at bile tract cancer, specifically cholangiocarcinoma. This status provides incentives and market exclusivity for seven years post-approval, highlighting the treatment’s potential in addressing a rare cancer with limited options. The decision was supported by promising results in Imugene’s ongoing MAST trial, which showed significant clinical responses in patients.

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