Evgen Pharma PLC (AIM:EVG, FRA:8EV) said its SFX-01 drug has been granted an orphan drug designation (OD) by the US Food and Drug Administration (FDA) for the treatment of malignant glioma.
The clinical stage drug development company submitted its application for OD designation on 13 July 2021.
Dr Huw Jones, CEO of Evgen, said: "We are delighted that our team and advisors have successfully gained Orphan Drug designation for SFX-01 in the USA in a very short period of time. This is part of a wider strategy to access the US market and positions us well for further investigations of our lead asset in this devastating brain cancer as we continue to optimize SFX-01 for clinical trials and eventually partnering.''