This page aggregates HRMY'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 |
|---|---|---|---|
| 2026-02-17 | APPROVAL | -4.9% | +7.0% |
| 2025-02-19 | CRL | +7.5% | +14.1% |
| 2024-06-24 | APPROVAL | -9.6% | +5.2% |
Harmony Biosciences Holdings, 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, 2 in our archive: 1 approval(s) and 1 Complete Response Letter(s). The most recent was on February 17, 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 3 decisions: -4.9% from T-120 to the eve, +7.0% 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.