regulatory
confidence high
sentiment positive
materiality 0.65
Meiji submits additional application in Japan for booster dose of Arcturus' COVID-19 vaccine ARCT-154
Arcturus Therapeutics Holdings Inc.
- Meiji Seika Pharma submitted a booster dose application for ARCT-154 in Japan based on Phase III data meeting primary endpoint.
- This follows the April 28 NDA for primary immunization; ARCT-154 is a self-amplifying mRNA vaccine developed by Arcturus.
- The Phase III trial (jRCT2071220080) compared ARCT-154 to COMIRNATY booster; no clinically significant safety concerns.
- If approved, ARCT-154 would be a new COVID-19 vaccination option in Japan; distribution via CSL Seqirus agreement.