This page aggregates MRNA's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.
| Decision | Outcome | T-120 to eve | T-120 to peak |
|---|---|---|---|
| 2026-08-05 | APPROVAL | +35.7% | +94.8% |
| 2025-08-27 | APPROVAL | -29.8% | +2.1% |
| 2025-06-12 | APPROVAL | -33.7% | +13.6% |
| 2025-05-31 | APPROVAL | -36.2% | +14.2% |
| 2024-08-22 | APPROVAL | -6.1% | +80.6% |
| 2024-06-07 | APPROVAL | +96.8% | +112.0% |
| 2024-05-31 | APPROVAL | +88.0% | +106.7% |
| 2023-09-11 | APPROVAL | -28.2% | +7.0% |
| 2022-12-08 | APPROVAL | +47.8% | +60.4% |
| 2022-10-12 | APPROVAL | -19.6% | +29.3% |
| 2022-08-31 | APPROVAL | -4.6% | +36.3% |
| 2022-01-31 | APPROVAL | -67.1% | +0.0% |
mRNA-1010 is a seasonal flu shot built on the same basic technology as Moderna's COVID-19 vaccines. Instead of using grown-and-inactivated flu virus, it carries genetic instructions that tell your own cells to briefly make one protein from the surface of the flu virus, which teaches your immune system to recognise the real thing. It is intended to prevent seasonal flu in adults aged 50 and over.
In clinical terms. Lipid-nanoparticle-formulated messenger RNA vaccine encoding hemagglutinin (HA) glycoproteins from WHO-recommended influenza strains. Trivalent, 37.5 micrograms total (12.5 micrograms per strain). Non-egg-based. Efficacy reported against A/H1N1, A/H3N2 and B/Victoria. Source
Over about six months, 2.0% of people who got mRNA-1010 caught a lab-confirmed flu-like illness, against 2.8% of people who got an ordinary flu shot. That gap of 0.8 percentage points is what the widely quoted "26.6%" describes: it is the difference expressed as a proportion, not the share of people protected. Because the comparison was against another licensed vaccine rather than a dummy injection, the result says this shot did better than an existing shot. It cleared the hardest of three statistical bars that were written down before the trial began, so the win was not a case of moving the goalposts afterwards.
The numbers. Relative vaccine efficacy against RT-PCR-confirmed, protocol-defined influenza-like illness from at least 14 days post-vaccination. Hierarchical testing for non-inferiority, superiority, and higher-level superiority (>9.1%); all three met. rVE 26.6% (95% CI 16.7 to 35.4). 411/20,179 cases against 557/20,124. By strain: A/H1N1 29.6%, A/H3N2 22.2%, B/Victoria 29.1%. Adults 65 and over 27.4%. Median follow-up 181 days. Randomised, active-controlled, 40,703 participants randomised and vaccinated across 11 countries, against a licensed standard-dose seasonal influenza vaccine. Source
Reactions to the shot itself were about twice as frequent as with the standard vaccine: sore arm in 66% against 30%, tiredness in 45% against 20%. These were described as mostly mild to moderate and short-lived. The more serious category of adverse events was similar between the two groups.
The numbers. Solicited adverse reactions, mRNA-1010 against standard-dose comparator: injection-site pain 65.8% / 29.8%, fatigue 45.1% / 20.3%, headache 37.8% / 18.0%, myalgia 35.4% / 11.6%. Serious adverse events 2.2% (3 investigator-assessed as vaccine-related) against 1.9% (2 vaccine-related). Source
In February 2026 the FDA refused even to file Moderna's application. The stated reason was not safety and not the efficacy result: it was the choice of comparison vaccine. Moderna tested against a standard-dose flu shot, while the CDC's advisory committee preferentially recommends stronger vaccines for people over 65, which is a large part of the group this shot is meant for. Moderna's position is that the FDA's own vaccines centre had earlier written that a standard-dose comparator would be acceptable, and that two already-licensed flu vaccines were approved using the same design. The application was refiled and accepted two weeks later. [1] [2]
Closing price on the announcement date against the previous close, measured from daily data when this page was built. Announcements made before the open move that day; announcements after the close move the next session. This records what happened, and does not claim the announcement caused it.
| Date | Event | Move | Close |
|---|---|---|---|
| 2026-08-05 | FDA approval announced | -1.3% | $56.99 to $56.26 |
| 2026-06-18 | FDA advisory committee voted 9-0 in favour | +3.5% | $61.80 to $63.96 |
| 2026-05-06 | NEJM publication of the pivotal data announced | +4.5% | $46.71 to $48.79 |
| 2026-02-10 | Refusal to File letter disclosed | +0.1% | $41.95 to $41.99 |
| 2025-06-30 | Phase 3 topline announced | +1.6% | $27.16 to $27.59 |
Compiled from primary sources and last reviewed 2026-08-06. Every figure above links to the filing, regulator document or journal it came from. This is information, not investment advice, and nothing here forecasts an FDA decision.
Moderna Inc. has no dated FDA catalyst on our calendar right now. That means no scheduled decision or readout date has been published in a source we can point to, not that none exists. We would rather say that than estimate one.
Yes, 4 in our archive: 4 approval(s) and 0 Complete Response Letter(s). The most recent was on August 5, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.
Measured from this company's own daily closing prices: Median across these 14 decisions: -5.3% from T-120 to the eve, +48.3% to the peak. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.
FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.