Vietnam's Health Ministry Approves Phase 2, Phase 3 Cohorts Of Arcturus' COVID-19 Vaccine Trial

Arcturus Therapeutics Holdings Inc ARCT has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 trial, which consisted of a two-dose regimen with injections 28 days apart.
The Vietnam Ministry of Health has reviewed the safety data in the Phase 1 part of the study and has permitted Phase 2 and Phase 3a cohorts.
The Phase 2 and Phase 3a studies will evaluate safety and immunogenicity in an additional 900 subjects. Recruitment of these cohorts is now progressing.
The subsequent Phase 3b will assess safety and efficacy in approximately 20,000 subjects. Dosing is planned for the first week of October.
Emergency Use Authorization filing in Vietnam could be as soon as December 2021.
The tolerability profile of ARCT-154 in the Phase 1 study was favorable.
Related: Arcturus Therapeutics Stock Jumps On mRNA COVID-19 Vaccine Update.
Price Action: ARCT stock is up 3.81% at $53.79 during the market session on the last check Wednesday.