Moderna, Inc. (MRNA) announced Friday that the U.S. Food and Drug Administration's review of the Biologics License Application or BLA for mRNA-1345, its investigational respiratory syncytial virus or RSV vaccine, will be delayed.
In pre-market activity on the Nasdaq, Moderna shares were losing around 2.3 percent to trade at $119.91.
The FDA informed the company that it does not expect to complete its review of the BLA by the previously communicated Prescription Drug User Fee Act or PDUFA date of May 12 that due to administrative constraints.
The agency has indicated that it expects to complete the review by end of May.
Meanwhile, the FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345.
Moderna said it remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices or ACIP June 26-27, 2024, meeting, which is necessary prior to commercial launch.
Stephen Hoge, President of Moderna, said, "Moderna is very grateful to the FDA for their continued efforts and diligence. We look forward to helping the agency complete the review of our application, and to the June ACIP meeting."
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