Arcturus partner Meiji reports Phase III success for bivalent COVID-19 booster in Japan

Arcturus Therapeutics Holdings Inc.

Bivalent ARCT-2301 (Kostaive) met primary endpoint of non-inferiority vs COMIRNATY bivalent in GMT ratio and SRR difference.
Superiority against Omicron BA.4/5 and Wuhan strain also confirmed in the phase III study in healthy Japanese adults.
No causally-related severe or serious adverse events reported; safety profile supports platform.
Study conducted by Meiji under distribution agreement with CSL Seqirus for Japan market.

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