pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › FDA Decisions › GKOS 2026-01-28

GKOS FDA Decision Approved · 2026-01-28

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/28/26$125.9$74.678/13/25
Daily close, T-120 (8/13/25) through T+5. Run-up high $125.9 on 1/22/26, low $74.67 on 10/30/25 (T-120 to T-1). FDA decision 1/28/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-01-28
DrugiDose TR
IndicationGlaucoma
Outcome✓ Approvedprimary-sourced
Decision-day move+4.4%
T-120 run-up (low→high)+58.0% ($74.67→$125.9)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA218010, action date 2026-01-27
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was iDose TR approved by the FDA?

Yes. The FDA approved the application for iDose TR on January 28, 2026. The primary source is linked on this page.

What was iDose TR under FDA review for?

The application covered Glaucoma. The FDA approved the application on January 28, 2026.

How did GKOS stock react to the FDA decision?

On the decision day GKOS moved +4.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.