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mRNA-1647 CMVictory Phase 3 Topline

MRNA·mRNA-1647·Cytomegalovirus Infection··NCT05085366
current best date
DEC
2026
MONTH7 months
Takeaway

First Phase 3 efficacy readout for any cytomegalovirus (CMV) vaccine — no CMV vaccine has ever been approved. Watch: vaccine efficacy against primary CMV infection in seronegative women aged 16–40, primary endpoint pre-specified at p<0.025.

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-1647
INN
MoApentavalent CMV vaccine

mRNA-1647 is Moderna's investigational cytomegalovirus (CMV) vaccine designed to protect against the most common cause of congenital viral infection in the United States. The vaccine encodes six CMV surface proteins — including the gH/gL pentameric complex — to elicit a broader immune response than prior single-antigen approaches that have failed in clinical trials. CMV infects roughly 1 in 200 infants born each year, causing permanent hearing loss and developmental disability; no CMV vaccine has ever been approved, making this the first Phase 3 efficacy trial for any CMV candidate.

Indication
Vaccines
Cytomegalovirus Infection
MeSH · D003586

No primer in glossary yet.

Trial
active
NCT05085366
CMVictory: Phase 3 Efficacy Study of mRNA-1647 in Seronegative Adults
Phase
Ph 3
N
7,300
Primary completion
Dec 30, 2026

Competitive landscape

1 peer in Vaccines · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
mRNA-1083MRNAmRNAcombination flu + COVID-19 mRNA vaccine

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. May 8, 2026·-11247m agopinned · highest confidence
    HIGH conf10-Q
    top claim
    DEC2026
    MONTH
    For our CMV vaccine candidate mRNA-1647, we anticipate primary efficacy data from the Phase 3 CMVictory trial in December 2026.

    contextMD&A — Recent Developments section, Form 10-Q for Q1 2026.

    conf 89%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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