secwatch.observer — SEC 8-K summary
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Issuer:     Arcturus Therapeutics Holdings Inc. (ARCT)
CIK:        0001768224
Form:       8-K
Filed at:   2024-03-19T23:59:59+00:00
Accession:  0001193805-24-000392
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1768224/000119380524000392/0001193805-24-000392-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1768224/000119380524000392/e619378_8k-arct.htm
  HTML page:      https://secwatch.observer/filing/0001193805-24-000392

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