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ReadoutTopline Readoutreported

mRNA-1083 P304 Flu+COVID Phase 3 Topline

MRNA·mRNA-1083·Seasonal Influenza··NCT05955807
reported
APR 15
2026
EXACT
Takeaway

Reported 2026-04-15: combination flu + COVID vaccine met non-inferiority vs. licensed comparators in adults ≥50. mRNA-1083 is Moderna’s first non-COVID respiratory commercial candidate and the basis for a planned BLA filing.

What’s at stake

market · comparables · base rate · prior moves
Market opportunity
company filings
Peer comparables
1 readout
ClinicalTrials.gov
Stage base rate
~58%
BIO Industry Analysis 2023 (2011–2020)
Avg prior-readout move
historical price reactions
Drug
mRNA
mRNA-1083
INN
MoAcombination flu + COVID-19 mRNA vaccine

mRNA-1083 is Moderna's combination influenza and COVID-19 vaccine, designed as a single annual shot protecting against both respiratory viruses simultaneously. The vaccine delivers mRNA instructions encoding influenza hemagglutinin antigens alongside the SARS-CoV-2 spike protein, training the immune system to defend against both pathogens in one dose. A Phase 3 trial in adults aged 50 and older reported positive non-inferiority results versus licensed comparators in April 2026, supporting a planned BLA filing as Moderna's first non-COVID respiratory commercial candidate.

Indication
Vaccines
Seasonal Influenza
MeSH · D007251

No primer in glossary yet.

Trial
completed
NCT05955807
P304: Phase 3 Efficacy Study of mRNA-1083 (Flu+COVID)
Phase
Ph 3
N
8,000
Primary completion
Apr 1, 2026
Glossary · what this readout is measuring
1 term detected in the takeaway
  • BLAregulatory
    Biologics License Application

    FDA submission for approval of a biologic (antibody, gene/cell therapy, vaccine). Same clock as NDA.

Competitive landscape

1 peer in Vaccines · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
mRNA-1647MRNAmRNApentavalent CMV vaccineREADOUT · Dec 26

Prior MRNA reactions to Readout events

1 historical event · base rate, not prediction
Median 1W move
+32.0%
Median 1M move
+43.9%
Positive outcomes
1/ 1
100%
Negative outcomes
0/ 1
0%
DateHeadlineOutcome1W1M6M
Apr 2026mRNA-1083 P304 Flu+COVID Phase 3 Toplinepositive+32.0%+43.9%+28.7%

Historical MRNA stock reaction to past Readout catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 100%.

Disclosure trail

1 observation · sorted by confidence
  1. Apr 15, 2026·15d agopinned · highest confidence
    HIGH conf8-K
    top claim
    APR 152026
    EXACT
    Moderna today announced positive topline results from the Phase 3 P304 trial of mRNA-1083, a combination flu and COVID vaccine, demonstrating non-inferior immune responses versus separate licensed comparators in adults ≥50.
    conf 98%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.

Disclaimer·BioSight aggregates publicly available data (SEC EDGAR, ClinicalTrials.gov, FDA, company press releases) and is provided as is for informational purposes only. Nothing here is investment, financial, legal, tax, or medical advice, or an offer to buy or sell any security. We make no warranty as to accuracy, completeness, or timeliness; dates and filings may contain errors or be superseded without notice; past events do not predict future outcomes. To the maximum extent permitted by law, BioSight, its operators, contributors, and affiliates disclaim all liability for any loss or damage arising from use of or reliance on this site. You are solely responsible for your own investment decisions — consult a licensed professional before acting on any information.

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