Clinical Trials | June 14, 2024
Moderna announces positive Phase 3 efficacy data for next generation COVID-19 vaccine
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
The demand in Africa for COVID-19 vaccines has declined
Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance
Announces changes to commercial organization to prepare for multiple product launches in 2024 and 2025
The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157)
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
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