Arcturus Gets FDA OK for Phase 2 of Covid-19 Vaccine Candidate

 Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants

Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021

Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study.

https://finance.yahoo.com/news/arcturus-therapeutics-receives-fda-allowance-120100689.html