RTTNews | Nov 9, 2021 08:30AM EST

08:30 Tuesday, November 9, 2021 (RTTNews.com) - Shares of INOVIO (INO) surged 6% in pre-market trade on Tuesday as the FDA has lifted the partial clinical hold on INNOVATE phase 3 segment. This provides authorization to proceed for INNOVATE phase 3 segment for its COVID-19 vaccine candidate, INO-4800, in the U.S.

The global phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen, administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint is virologically confirmed symptomatic COVID-19.

INOVIO noted that the FDA has lifted the partial clinical hold following review of additional non-clinical, clinical, and device information provided by the company.

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