SAN DIEGO, Calif., July 2, 2026
Arcturus Therapeutics Holdings Inc. announced a strategic collaboration with Thermo Fisher Scientific to support the Phase 3 development and potential commercialization of ARCT-032, the company’s investigational messenger RNA (mRNA) therapy for cystic fibrosis. The agreement combines Thermo Fisher’s Accelerator™ Drug Development platform with integrated manufacturing, clinical research, and commercialization capabilities to accelerate late-stage development while strengthening future commercial readiness. Under the collaboration, Thermo Fisher will provide Phase 3 manufacturing, clinical research services, and commercial preparedness, enabling Arcturus to focus on advancing ARCT-032 toward regulatory approval.
If ongoing Phase 2 clinical studies deliver positive outcomes, the Phase 3 program is expected to be conducted through Thermo Fisher’s PPD™ clinical research business, while a separate agreement grants Thermo Fisher exclusive commercial manufacturing rights following regulatory approval. The collaboration represents a major milestone for Arcturus as it advances one of its most promising RNA therapeutic candidates for patients living with cystic fibrosis, a serious inherited respiratory disease with significant unmet medical need.
Thermo Fisher Brings End-to-End Development and Manufacturing Expertise
The strategic partnership leverages Thermo Fisher Scientific’s global CDMO infrastructure and integrated drug development capabilities to simplify the transition from late-stage clinical development to commercial manufacturing. Through its Accelerator™ Drug Development solutions, Thermo Fisher will combine manufacturing, clinical research, and commercialization services into a unified development program designed to reduce operational complexity and improve development timelines.
According to Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics, Thermo Fisher’s expertise in supporting complex mRNA development programs aligns closely with the company’s objective of efficiently progressing ARCT-032 into Phase 3 while preparing for long-term commercial supply. The collaboration also reflects the growing trend of biotechnology companies partnering with experienced contract development and manufacturing organizations to improve scalability, regulatory readiness, and commercialization efficiency for advanced biologic therapies.
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ARCT-032 Advances Arcturus’ RNA Therapeutics Pipeline
ARCT-032 is an investigational mRNA therapeutic being developed to treat cystic fibrosis, one of several rare disease programs within Arcturus’ expanding RNA medicines portfolio. The company has developed multiple proprietary technologies, including LUNAR® lipid-mediated delivery and STARR® self-amplifying mRNA technology, which support the design and delivery of next-generation RNA therapeutics. These platforms have already contributed to the development of KOSTAIVE®, the world’s first approved self-amplifying mRNA COVID-19 vaccine, demonstrating Arcturus’ capabilities in advancing innovative RNA medicines from research through commercialization. Beyond cystic fibrosis, the company’s pipeline includes therapies targeting ornithine transcarbamylase (OTC) deficiency, pandemic influenza, and other respiratory and liver diseases, highlighting the broad potential of its proprietary RNA technology platforms.
Strategic Collaboration Positions ARCT-032 for Commercial Success
The collaboration with Thermo Fisher Scientific extends beyond clinical development by establishing a long-term commercial manufacturing pathway for ARCT-032. Subject to regulatory approval, Thermo Fisher will become the exclusive commercial manufacturing partner, ensuring reliable production capacity for future global commercialization. The agreement also reinforces Arcturus’ strategy of combining innovative RNA therapeutic platforms with experienced manufacturing and clinical development partners to accelerate product launches while maintaining high-quality production standards. Backed by a global intellectual property portfolio of more than 500 patents and patent applications, Arcturus continues to strengthen its leadership in mRNA therapeutics, positioning ARCT-032 as a key pipeline asset with the potential to deliver a new treatment option for patients with cystic fibrosis while expanding the commercial reach of the company’s next-generation RNA medicine platform.
Source: Arcturus Therapeutics press release
