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LEXX FDA Decision Approved · 2025-01-15

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

Daily close, T-120 (7/31/24) through T+5. Run-up high $4.09 on 8/7/24, low $1.93 on 1/14/25 (T-120 to T-1). FDA decision 1/15/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-15

DrugDehydraTECH-liraglutide - (GLP-1-H25-5). (Pilot Study #5)

IndicationObesity

Outcome✓ Approvedprimary-sourced

Decision-day move-1.6%

T-120 run-up (low→high)+0.0% ($1.9→$3.43)

ValidationVerified 2026-08-12: SEC filing 0001640334-25-000087 of 2025-01-15 containing 'approval of'

Market-cap tierNano

Cohort decision-day move (history)8.0% median (n=122)

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was DehydraTECH-liraglutide - (GLP-1-H25-5). (Pilot Study #5) approved by the FDA?

Yes. The approval of the application for DehydraTECH-liraglutide - (GLP-1-H25-5). (Pilot Study #5) was announced on January 15, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

What was DehydraTECH-liraglutide - (GLP-1-H25-5). (Pilot Study #5) under FDA review for?

The application covered Obesity. The FDA approved the application on January 15, 2025.

How did LEXX stock react to the FDA decision?

On the decision day LEXX moved -1.6%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.