Moderna (NASDAQ:MRNA) shares are down just over 1% in early Friday trading after the company said the FDA has informed it that it will not be able to meet the May 12 PDUFA for their RSV vaccine due to "administrative constraints."
However, they remain on track for a decision by the end of May, which analysts at Jefferies note is imperative for the company to be on the June 26 to 27 ACIP agenda for a recommendation ahead of the launch in August.
In the Moderna press release, Stephen Hoge, the company's president, 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."
Analysts at Jefferies believe the update removes the Street's worst-case scenario of a complete response letter (CRL) or three-month delay for a major amendment. The investment firm added that the next key update is the second season efficacy data at June ACIP.