secwatch.observer — SEC 8-K summary
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Issuer:     Arcturus Therapeutics Holdings Inc. (ARCT)
CIK:        0001768224
Form:       8-K
Filed at:   2023-06-30T23:59:59+00:00
Accession:  0001193805-23-000929
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Meiji submits additional application in Japan for booster dose of Arcturus' COVID-19 vaccine ARCT-154
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1768224/000119380523000929/0001193805-23-000929-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1768224/000119380523000929/e618740_8k-arct.htm
  HTML page:      https://secwatch.observer/filing/0001193805-23-000929

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