Moderna says FDA will not complete review of RSV vaccine by May 12 deadline

By Ciara Linnane

Regulator has told the biotech it expects the review will be done by the end of May

Moderna Inc.'s stock fell 2.6% Friday, after the company said the Food and Drug Administration will not complete its review of the company's respiratory syncytial virus, or RSV, vaccine by the original deadline of May 12.

The FDA cited administrative constraints for the delay, Cambridge, Mass.-based Moderna said in a statement. The regulator has told the company it expects to conclude the review by the end of the month.

"The FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345," as the vaccine is called, said the statement.

Moderna (MRNA) said it's still on track for the vaccine to be reviewed at the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices meeting scheduled for June 26 to 27. That's a necessary step before a commercial launch.

William Blair analysts said that while regulatory delays are disappointing and typically create "noise" around the probability of approval, "given the "administrative constraints" information currently available and known FDA backlogs, today's news does not alter our expectation that mRNA-1345 will receive approval under the current BLA review cycle," referring to the Biologics License Application process.

Analysts Myles Minter and Sarah Schram noted the company has said it believes the total addressable market for the vaccine is $10 billion. Protein-based vaccines developed by GlaxoSmithKline and Pfizer Inc. already generated $1.5 billion and $890 million respectively in 2023 revenue early in their product launch cycles, said the note.

William Blair is expecting Moderna to generate $1.46 billion in peak U.S. sales of mRNA-1345, which will make it an important return to growth for 2025 and a 2026 breakeven story.

The analysts have a market perform rating on the stock.

Moderna did not comment on whether the delay will impact its guidance for 2024, which it reiterated in early May when it reported first-quarter earnings. The company guided for $4 billion in product sales for the year, including sales of its COVID-19 vaccine, as well as the RSV vaccine, which it was hoping to launch in time for the fall vaccination season.

The COVID vaccine is Moderna's first-and for now only-FDA-approved product. The company is developing a range of vaccines to treat other respiratory illnesses, such as flu, and is developing a combination flu/COVID vaccine, as well as vaccines for cancer and rare diseases.

The company has 10 late-stage products in its pipeline.

The stock has gained 20.6% in the year to date, while the S&P 500 SPX has gained 9.3%.

-Ciara Linnane

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05-10-24 0952ET

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