Moderna looks out to R&D ‘horizons’ as 2028 break-even goal looms

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Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.

After running into an FDA-shaped speedbump earlier this year, Moderna appears to have regrouped and is plotting an R&D roadmap for the coming years as the company continues to move toward its goal of breaking even in 2028.

During its Science Day investor event on Thursday, Moderna broke down its pipeline into three waves—or “horizons,” as the company calls them. The first focuses on its most mature assets, including both late-stage candidates and commercial products, designed and developed using the company’s established mRNA modalities.

“By 2027-28, MRNA could be marketing 7+ products” across the respiratory disease, oncology and rare disease spaces, Jefferies told investors in a Thursday note. The company has three marketed products at the moment: the COVID vaccines Spikevax and mNEXSPIKE and the respiratory syncytial virus shot mRESVIA.

Further building out its commercial portfolio will prove critical for Moderna’s goal of hitting its well known break-even target in 2028, especially after recent regulatory roadblocks. The FDA in February refused to review the company’s mRNA flu vaccine mFluvisa (mRNA-1010), citing issues with how the pivotal study was conducted. Faced with strong industry blowback, however, the agency backtracked and days later accepted the application for review.

MFluvisa has since made a triumphant comeback, winning overwhelming support from a panel of independent FDA advisors last week. The agency’s Vaccines and Related Biological Products Advisory Committee unanimously supported the shot’s full approval in adults aged 50 through 64 years, and its accelerated approval in those 65 years and older.

The FDA is expected to make a decision on or before Aug. 5.

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

An approval for mFluvisa would give a boost to another of Moderna’s first-horizon assets, Jefferies said, “enabling MRNA to seek FDA clarity on mCombriax,” the company’s combination shot for flu and COVID. The vaccine won European approval in April, but its U.S. prospects may be dimmer. In May 2025, Moderna pulled its FDA application for mCombriax, saying a resubmission hinged on further data for mFluvisa.

Aside from respiratory vaccines, the first horizon of Moderna’s R&D strategy also includes its personalized cancer shot intismeran autogene, which the company is developing alongside Merck’s Keytruda for high-risk advanced melanoma. Jefferies expects data for this indication to come later this year, with additional readouts continuing through 2027. The shot is also in late-stage development for non-small cell lung cancer and mid-stage assessments for renal cell and bladder cancers.

These products, along with Moderna’s May forecast of a 10% year-on-year revenue growth, could help the biotech “reduce cash burn . . . ensuring 2028 cash breakeven,” Jefferies said.

Moderna on Thursday also looked out to further horizons, presenting its pipeline built on emerging modalities. The company’s second horizon includes assets currently in the clinic, such as cancer antigen therapies, cell therapy enhancers and T cell engagers, plus an investigational asset for multiple sclerosis.

Longer-term, the biotech is also looking to expand into future treatment modalities, with its push powered by AI and other advanced technologies. Modalities under this third horizon include in vivo dual CAR T treatments, in vivo CAR M assets and tolerizing therapies.

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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