Moderna presented its research and development roadmap on June 26 as the company continues to work toward its goal of breaking even in 2028. The announcement came during Moderna's Science Day investor event, where the company described a three-wave pipeline approach, referred to as 'horizons.'
The first horizon focuses on Moderna’s most mature assets, including late-stage candidates and commercial products developed with established mRNA technologies. Currently, Moderna markets three products: the COVID vaccines Spikevax and mNEXSPIKE, along with the respiratory syncytial virus vaccine mRESVIA. Jefferies told investors that “by 2027-28, MRNA could be marketing 7+ products” across respiratory disease, oncology, and rare disease areas.
Expanding its commercial portfolio is seen as critical for achieving the break-even target in 2028. Earlier this year, Moderna faced regulatory challenges when the Food and Drug Administration initially refused to review its mRNA flu vaccine application for mFluvisa (mRNA-1010), citing concerns about how pivotal studies were conducted. After industry feedback, the agency accepted the application days later.
MFluvisa recently received unanimous support from an independent FDA advisory committee for full approval in adults aged 50 through 64 years and accelerated approval for those aged 65 years or older. The FDA is expected to make a decision by August 5.
Jefferies said that an approval for mFluvisa would benefit another first-horizon asset by “enabling MRNA to seek FDA clarity on mCombriax,” a combination flu and COVID shot which won European approval in April but faces delays in U.S. submission pending further data from mFluvisa trials.
Beyond respiratory vaccines, Moderna’s first horizon includes intismeran autogene—a personalized cancer shot being developed with Merck’s Keytruda for high-risk advanced melanoma—with additional studies underway for other cancers. Jefferies said these products and a projected annual revenue growth of ten percent could help reduce cash burn and ensure cash breakeven by 2028.
The second horizon features clinical-stage assets such as cancer antigen therapies, cell therapy enhancers, T cell engagers, and an investigational treatment for multiple sclerosis. Looking further ahead under its third horizon strategy, Moderna aims to develop new modalities powered by artificial intelligence—including in vivo dual CAR T treatments and tolerizing therapies.
