Meiji submits NDA in Japan for ARCT-154, Arcturus' self-amplifying mRNA COVID-19 vaccine

Arcturus Therapeutics Holdings Inc.

Meiji Seika Pharma filed NDA for primary immunization (two doses) of ARCT-154 in Japan.
NDA based on Phase III trial in Vietnam (NCT05012943) with >16,000 subjects; met primary endpoint of COVID-19 prevention.
Meiji holds exclusive Japan distribution rights from CSL Seqirus; Arcturus developed the vaccine.
ARCT-154 uses next-gen mRNA technology for strong immune response and potential lower dosing.
Meiji collaborates with ARCALIS to build mRNA manufacturing in Minami-soma, Fukushima.

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