Arcturus reports ARCT-032 CF interim data showing mucus reduction; KOSTAIVE BLA submission delayed by FDA

Arcturus Therapeutics Holdings Inc.

ARCT-032 Phase 2 interim: generally safe/tolerated; 4 of 6 Class I CF patients showed mucus plug/volume reduction after 28 days (10 mg).
FDA requested delay of KOSTAIVE BLA submission (Sep 5), then required additional clinical endpoint efficacy study per updated COVID-19 framework.
CSL Seqirus submitted KOSTAIVE MAA to UK MHRA in June 2025; approval expected Q1 2026, but not assured.
Company filed lawsuit Sep 23, 2025 against AbbVie and Capstan Therapeutics for trade secret misappropriation and breach of contract.
12-week safety/efficacy study of ARCT-032 in up to 20 CF participants planned to start first half of 2026.

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