Arcturus and Thermo Fisher form CDMO/CRO pact for cystic fibrosis mRNA drug

Arcturus Therapeutics Holdings Inc. disclosed in an 8-K that its subsidiary entered into a series of agreements with Thermo Fisher Scientific Inc. and certain of its affiliates on June 26, 2026 to establish a strategic collaboration for CDMO and CRO services tied to ARCT-032, its investigational mRNA therapeutic for cystic fibrosis.¹ The arrangement is built from a Master Services Agreement between Thermo Fisher and Arcturus and a Project Addendum for Development Services between Patheon UK Limited, a Thermo Fisher affiliate, and Arcturus.¹

Under the MSA, CRO services will be provided through PPD, Inc. while CDMO services come through Thermo Fisher's Pharma Services division, with Thermo Fisher contributing up to $40 million of clinical manufacturing services and Arcturus engaging PPD for up to $40 million in CRO services.¹ If ARCT-032 wins regulatory approval, Thermo Fisher would receive exclusive commercial manufacturing rights for a specified duration, on terms to be negotiated in a definitive commercial supply agreement.¹ Arcturus retains a limited backup option: it may engage an alternative manufacturer only if Thermo Fisher is unable to supply, and only to the extent needed to cover the shortfall.¹ The MSA carries an initial five-year term that renews automatically in one-year increments unless either side gives at least 90 days' notice of non-renewal.¹

Separately, the Project Agreement covers technical transfer, engineering batches, clinical trial material manufacture, process performance qualification batches, open-label extension batches, fill and finish, product release, and stability studies.¹

The company said if Phase 2 results are positive, Arcturus expects to run its Phase 3 program through Thermo Fisher's PPD clinical research business.¹ Full agreement text is expected to be filed as an exhibit to Arcturus's Quarterly Report on Form 10-Q for the quarter ending June 30, 2026.¹