Shares of Evgen Pharma are surging on Thursday after the clinical-stage drug development company announces the grant of an Orphan Drug Designation (OD) by the US Food and Drug Administration (FDA) for the use of SFX-01 to treat malignant glioma.
Evgen submitted an Orphan Drug application to the FDA on 13 July. OD is usually granted when there are fewer than 200,000 patients with a given disease in the United States and there is a scientific rationale for the potential use of the product in that condition.
OD also awards intellectual property cover to an investigational drug in the form of data protection, which is additional to any patent cover in force. Tax credits are also possible on eventual US sales of an approved orphan drug.
Dr Huw Jones, CEO of Evgen, commented: “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.”
The company's shares are trading at 8.02p after a 25.47% rise from Wednesday's close.
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