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Disc Medicine, Inc. (IRON) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Disc Medicine, Inc. · no upcoming catalyst on file · 3 past FDA decisions

FDA decision history (3)

Feb 15, 2026✕ CRLFDA decisionFeb 13, 2026✕ CRLFDA decisionJan 21, 2025✓ ApprovedFDA decision

Clinical readouts (1)

2026-09DISC-3405 readout
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This page aggregates IRON'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.

IRON run-up, measured

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.

IRON's past FDA decisions (n=3)
DecisionOutcomeT-120 to eveT-120 to peak
2026-02-15CRL-7.3%+55.9%
2026-02-13CRL+19.9%+57.5%
2025-01-21APPROVAL+27.5%+47.7%
Median across these 3 decisions: +19.9% from T-120 to the eve, +55.9% to the peak. A median over 3 events describes this stock's past only. It is not a forecast, and the cohort figures on the run-up study are the larger statistical base.

Common questions

When is the next FDA decision or readout for Disc Medicine, Inc. (IRON)?

Q3 2026. The next catalyst for Disc Medicine, Inc. is DISC-3405 readout. That date is known to the quarter only. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has Disc Medicine, Inc. (IRON) had an FDA decision before?

Yes, 3 in our archive: 1 approval(s) and 2 Complete Response Letter(s). The most recent was on February 15, 2026 and was a Complete Response Letter. Each one has its own page with the source document and the share-price reaction we measured.

How has IRON stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 3 decisions: +19.9% from T-120 to the eve, +55.9% to the peak. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this IRON data come from?

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.