07:33 AM EDT, 05/21/2025 (MT Newswires) -- Moderna ( MRNA ) said Wednesday that it has voluntarily withdrawn its Biologics License Application for mRNA-1083, its flu and COVID combination vaccine candidate for adults aged 50 and older.
The biotech firm said it will resubmit the BLA after vaccine efficacy data from a late-stage trial of its investigational seasonal influenza vaccine mRNA-1010 are available.
Moderna ( MRNA ) said it expects interim data from the mRNA-1010 trial to be available this summer.
The decision to withdraw the license was made in consultation with the US Food and Drug Administration, the company said.
Shares of Moderna ( MRNA ) were down 1.4% in recent Wednesday premarket activity.