Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) is collaborating with Thermo Fisher Scientific Inc. (NYSE:TMO) to support the Phase 3 development and potential commercialization of ARCT-032, the company’s investigational messenger RNA therapy for cystic fibrosis.
Thermo Fisher To Support Phase 3 Development
The collaboration brings together Thermo Fisher’s Accelerator Drug Development solutions, which combine manufacturing and clinical research capabilities, to support ARCT-032 through late-stage development and potential commercialization.
Under the agreement, Thermo Fisher will provide Phase 3 manufacturing, clinical research, and related services while Arcturus continues advancing the ARCT-032 program.
The partnership is designed to streamline development by integrating manufacturing, clinical research, and commercial readiness services as the investigational therapy moves toward its next stage.
Commercial Manufacturing Planned If Therapy Wins Approval
Arcturus said it expects to conduct its Phase 3 clinical program through Thermo Fisher’s PPD clinical research business if its ongoing Phase 2 study produces positive results.
The agreement also outlines a potential commercial relationship beyond clinical development. Subject to regulatory approval of ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement.
ARCT-032 is an inhaled mRNA therapeutic candidate for cystic fibrosis, a rare genetic disease.
Arcturus initiated enrollment of a new cohort in March 2026. The open-label Phase 2 clinical study is currently enrolling up to 20 participants.
The study will monitor 10 mg dosing over 12 weeks for safety and evidence of early clinical benefits, including assessment of lung functional improvements, two validated quality‑of‑life outcome measures, and evaluation of any changes in high-resolution computed tomography imaging.
ARCT Stock Price Activity: Arcturus Therapeutics shares were up 12.19% at $7.73 at the time of publication on Thursday, according to Benzinga Pro data.
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