Moderna’s Flu Vaccine Application Accepted with August 5 PDUFA Date
Moderna’s mRNA-1010 flu vaccine biologics license application was accepted for review, with an FDA PDUFA goal date of August 5. Moderna posted a Q4 loss of $2.11 per share on $678 million sales, exceeding estimates.
1. FDA Review of mRNA-1010
Moderna’s biologics license application for the mRNA-1010 flu vaccine has been accepted by the FDA, with a Prescription Drug User Fee Act goal date set for August 5 to complete the review process.
2. Q4 Financial Performance
In the fourth quarter Moderna reported a loss of $2.11 per share on $678 million in sales, both surpassing analysts’ expectations of a $2.59 loss and $626.1 million in revenue.
3. 2026 Outlook and Growth Targets
The company targets up to 10% revenue growth from 2025’s $1.94 billion and plans additional regulatory submissions in multiple regions with potential approvals in 2026 pending reviews.