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ARCT-032 generally safe and well tolerated
Meaningful trends of clinical activity observed via high resolution CT scans
After only 28 days of treatment with ARCT-032 (10 mg), 4 out of 6 Class I CF participants exhibited encouraging reduction of mucus plug number and mucus volume
12-week study enrolling up to 20 CF participants planned to begin first half of 2026
Arcturus Therapeutics Holdings Inc. ((the "Company", "Arcturus", NASDAQ:ARCT), a commercial messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced interim results from its ongoing Phase 2 clinical trial of ARCT-032, an investigational inhaled mRNA therapy for people with cystic fibrosis.
In the second cohort of the study, six Class I CF adults received inhaled 10 mg doses of ARCT-032 daily over 28 days. The treatment was generally safe and well tolerated. Treatment related AEs that were identified in the single-dose Phase 1 study were also observed in some participants for the first few doses but ceased with continued dosing. One SAE occurred in a participant well after the end of the dosing period. The Data Monitoring Committee found no convincing evidence that the SAE is related to ARCT-032 and approved the study to proceed. The expanded third cohort is ongoing and aims to enroll up to six subjects to determine if there is a dose escalation response at 15 mg and if ARCT-032 continues to be generally safe and well tolerated. The Company intends to initiate a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026.
Posted In: ARCT
