Moderna stock toppled Friday after the Food and Drug Administration delayed an approval decision on its RSV vaccine until the end of the month.
The news pushes back the potential approval of the vaccine for respiratory syncytial virus by roughly two weeks. The FDA was due to make a decision by May 12. Moderna emphasized the FDA has not said it found any issues related to vaccine effectiveness, safety or quality that would prevent approval.
William Blair analyst Myles Minter cited "administration constraints" at the FDA for the delay.
"Although regulatory delays are disappointing and usually 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 (Moderna's RSV vaccine) will receive approval under the current (biologics license agreement) review cycle," he said in a report.
On today's stock market, Moderna stock 4.4% to close at 117.31. Shares recently broke out of a cup-with-handle base, topping a buy point at 115.89, according to MarketSurge.
Moderna Stock: Trailing Pfizer, GSK
If approved, Moderna's RSV vaccine would be the third to hit the market this fall, behind shots from Pfizer and GSK. Pfizer and GSK gained their approvals last year and launched in the fall.
RSV, the shorthand name for respiratory syncytial virus, typically causes cold-like symptoms in most people. But it can cause serious or even deadly lung infections in babies and older adults. Arexvy and Abrysvo, from GSK and Pfizer, are approved for people age 60 and older.
Importantly, the delay won't jeopardize Moderna's ability to participate in an Advisory Committee on Immunization Practices meeting scheduled for June 26 to June 28. The ACIP makes recommendations on which vaccines should be included in the U.S. fall vaccine campaign.
William Blair's Minter kept his market perform rating on Moderna stock.
He notes Moderna has estimated a $10 billion total addressable market for RSV vaccines. Arexvy and Abrysvo generated $1.5 billion and $890 million, respectively, in their first year on the market. He sees a peak of $1.46 billion for Moderna's shot in the U.S.
Still, the product "remains an important contributor to Moderna's return to growth in 2025 and 2026 break-even story," he said.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
