U.S. FDA lifts clinical hold on Inovio’s COVID-19 vaccine trial

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Inovio said it now has the authorization 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.

Following the decision, the U.S. 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.