08:04 AM EDT, 05/10/2024 (MT Newswires) -- (Updates with more details in the second and third paragraphs.)

The US Food and Drug Administration has informed Moderna ( MRNA ) that it has pushed back approval of the company's Biologics License Application for its investigational respiratory syncytial virus vaccine to the end of May from the previously communicated Prescription Drug User Fee Act date of May 12 due to "administrative constraints," Moderna ( MRNA ) said Friday.

Moderna ( MRNA ) said the FDA has not raised any vaccine safety, efficacy, or quality issues that might prevent approval of the drug, also called mRNA-1345.

Moderna ( MRNA ) also said it remains on track for a June 26-27 Centers for Disease Control advisory committee review of mRNA-1345 ahead of a possible commercial launch.

Moderna ( MRNA ) shares were 2.4% lower in premarket trading.

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