Moderna Inc (MRNA)

[axelvento]

Last month, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. If approved, mRNA-1345 could be Moderna’s second product launch.

Earlier this month, Moderna announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses againstthe influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end. Given the company’s accelerated timetable for mRNA-1010, we expect mRNA-1010 to be the company’s third product launch, expected in the next year.

Data from the study showed that mRNA-4157combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Merck’s Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival.

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