Yeji

$ARCT

Arcturus Therapeutics Holdings Inc.

Runway:33 mo
NasdaqMarket cap: —CIK 0001768224

Upcoming catalysts

1 surfaced
NDA/BLA filedDate TBD~ low confidence
$ARCTArcturus Therapeutics Holdings Inc.
“On September 5, 2025, the week prior to the planned Biologics License Application ("BLA") submission related to KOSTAIVE, the U.S. Food and Drug Administration requested that the Company delay its submission of the BLA filing based on the FDA's expectation of providing additional advice.”

Drug pipeline

ARCT-032
Cystic Fibrosis
ARCT-2138
Influenza, Human
ARCT-2303
COVID-19
ARCT-165
COVID-19
ARCT-021 Dose 1
SARS-CoV-2
ARCT-2304
Influenza, Human
ARCT-810
OTC Deficiency
ARCT-021
SARS-CoV-2
ARCT-021 single dose priming
Covid19
kostaive
COVID-19 vaccine

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT06747858ARCT-032Phase 2Recruiting2027-06-01
NCT06488313ARCT-810Phase 2Recruiting2026-06-01
NCT06602531ARCT-2304Phase 1Completed2025-06-13
NCT05526066ARCT-810Phase 2Terminated2024-10-31
NCT06279871ARCT-2303Phase 3Completed2024-10-09
NCT06125691ARCT-2138Phase 1Completed2024-08-10
NCT05712538ARCT-032Phase 1Completed2024-07-29
NCT05037097ARCT-165Phase 2Completed2023-12-19
NCT04442347ARCT-810Phase 1Completed2023-08-30
NCT04668339ARCT-021 single dose primingPhase 2Terminated2022-03-01
NCT04728347ARCT-021Phase 2Terminated2021-12-28
NCT04480957ARCT-021 Dose 1Phase 2Completed2021-01-29
NCT04416126ARCT-810Phase 1Completed2020-12-09

Recent catalysts

CRLOct 14, 2025· 235d ago
$ARCTArcturus Therapeutics Holdings Inc.
kostaive · COVID-19 vaccine
“On October 14, 2025, the FDA informed the Company that, although the FDA had previously agreed that the Company's proposed data package could support a single-dose indication, upon further consideration it finds that additional data from a clinical endpoint efficacy study will be needed to align with the current COVID-19 vaccine regulatory framework requirements published in The New England Journal of Medicine in May 2025.”