secwatch.observer — SEC 8-K summary
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Issuer:     Arcturus Therapeutics Holdings Inc. (ARCT)
CIK:        0001768224
Form:       8-K
Filed at:   2025-08-29T23:59:59+00:00
Accession:  0001193805-25-001247
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Meiji Seika Pharma receives Japan approval for two-dose vial of KOSTAIVE® COVID-19 vaccine
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- Approval granted August 28, 2025 for new two-dose vial presentation of KOSTAIVE® (ARCT-2301) in Japan.
- Vaccine targets SARS-CoV-2 Omicron sub lineage JN.1 variant XEC; induces neutralizing antibodies against multiple variants.
- Meiji Seika Pharma plans to begin supply of the new presentation starting late September 2025.
- Non-clinical data shows neutralizing antibodies against JN.1, XEC, LP.8.1, XFG, and NB.1.8.1 variants.
- Distribution in Japan is under a prior agreement between Meiji and CSL Seqirus, partner of Arcturus.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1768224/000119380525001247/0001193805-25-001247-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1768224/000119380525001247/e664805_8k-arct.htm
  HTML page:      https://secwatch.observer/filing/0001193805-25-001247

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer