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MRNA PDUFA Date: mRNA-1010

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 5, 2026 on its goal date. Decision page with the source and measured reaction.
FDA decision Approved August 5, 2026 · Moderna Inc. · Seasonal influenza in U.S. adults 50 years of age and older
More Infectious Disease FDA decisions →All August 2026 PDUFA dates →

The story

mRNA-1010 was approved by the FDA on August 5, 2026 to treat seasonal influenza in adults 50 and older (an mRNA flu vaccine).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthGSK-tebipenem-hbr . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)SPRO . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)LNTH-florquinitau . 2026-08-13Same month decision . Florquinitau (MK-6240)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

MRNA run-up into the PDUFA (last ~120 days)

$61.8$45.37
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved August 5, 2026
FDA goal date2026-08-05
Drug / candidatemRNA-1010
IndicationSeasonal influenza in U.S. adults 50 years of age and older
CompanyModerna Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05415462 · completed

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on MRNA's mRNA-1010?
The FDA decided MRNA's (Moderna Inc.) application for mRNA-1010 on August 5, 2026: Approved. The FDA goal date for this application was 2026-08-05. Verify against the linked primary source.
What is MRNA's drug mRNA-1010?
mRNA-1010 is Moderna Inc.'s drug, approved by the FDA on August 5, 2026 for Seasonal influenza in U.S. adults 50 years of age and older.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.