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 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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In:
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!