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Opus Genetics, Inc. (IRD) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Opus Genetics, Inc. · 1 upcoming · 0 past FDA decisions

Upcoming FDA catalysts

IRD · Oct 17, 2026Phentolamine ophthalmic solution 0.75%: Presbyopia (sNDA)
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates IRD'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.

IRD 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.

Run-up so far, this catalyst
Since its T-120 baseline on 2026-04-28 ($5.00), IRD is -23.9% to $3.81 at the close on 2026-09-01. The highest close since that baseline is +7.2% above it.
88 of 120 sessions elapsed, 32 to go. Cohort context: across 1,839 past decisions the median peak from T-120 was 17.7% and the median move to the day before the decision was 2.0%.

Common questions

When is the next FDA decision or readout for Opus Genetics, Inc. (IRD)?

October 17, 2026. The next catalyst for Opus Genetics, Inc. is Phentolamine ophthalmic solution 0.75% (PDUFA). That date is a confirmed date. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

How has IRD stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-04-28 ($5.00), IRD is -23.9% to $3.81 at the close on 2026-09-01. The highest close since that baseline is +7.2% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this IRD 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.