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• Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia • Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint • TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 • FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) • Market access process initiated with UK NICE and EU JCA

The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.

Novartis and Antares Therapeutics are shooting for the stars, launching a joint mission to develop small molecule oncology therapies.