MRNA

Moderna, Inc.

FDA PDUFA Target Action Date

Wednesday, August 5, 2026

71 days away

Drug Information

Drug Name: mRNA-1010 (CT.gov)
Indication: Seasonal flu

Filing Details

Company: Moderna, Inc. →
Stock Ticker: MRNA
SEC CIK: 0001682852
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore Moderna, Inc.

View Moderna, Inc.'s full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue