FDA Lifts Clinical Hold On Inovio's COVID-19 Vaccine Trial

• The FDA has lifted a partial clinical hold on a late-stage trial of Inovio Pharmaceuticals Inc's (NASDAQ: INO) COVID-19 vaccine in the U.S.

• Inovio said it now has the authorization to proceed with the trial in the U.S. after 14 months.

• Last year in September, the FDA put the final-stage trial on hold. It sought more information, including details on a delivery device used to inject genetic material into cells.

• Inovio is partnering with Advaccine Biopharmaceuticals Suzhou Co Ltd to conduct the INNOVATE Phase 3 segment in the Americas, Asia, and Africa.

• The Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart.

• The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19.

• Related content: Benzinga's Full FDA Calendar.

• Price Action: INO shares are up 3.56% at $6.98 during the market session on the last check Tuesday.

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