US FDA lifts clinical hold on Inovio's Covid-19 vaccine trial
Inovio said it now has the authorisation to proceed with the trial after 14 months, sending its shares up 4.6% before the bell
Inovio Pharmaceuticals Inc said on Tuesday the US Food and Drug Administration (FDA) had lifted a partial clinical hold on late-stage trial of its Covid-19 vaccine within the country.
Inovio said it now has the authorisation to proceed with the trial after 14 months, sending its shares up 4.6% before the bell.
The FDA last year in September put the final-stage trial on hold as it sought more information from the company, including details on a delivery device used to inject genetic material into cells.
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Following the decision, the US government pulled funding for the late-stage study for Inovio's vaccine as other Covid-19 vaccines were already available in the country.
Inovio then started late-stage trials outside the United States in partnership with China's Advaccine Biopharmaceuticals.
The company is currently conducting the Phase 3 portion of its mid-to-late-stage trial in several regions including Latin America, Asia Pacific and Africa.
