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RHHBY FDA Decision Approved · 2025-03-03

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 (9/16/24) through T+5. Run-up high $42.04 on 2/26/25, low $34.24 on 12/26/24 (T-120 to T-1). FDA decision 3/3/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-03-03

DrugTNKase (tenecteplase)

IndicationAcute ischemic stroke (AIS) in adults

Outcome✓ Approvedprimary-sourced

Decision-day move+0.2%

T-120 run-up (low→high)+9.0% ($34.24→$43.05)

ValidationVerified 2026-08-12: Drugs@FDA, application BLA103909, action date 2025-02-28

Market-cap tierLarge

Cohort decision-day move (history)1.0% median (n=895)

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 TNKase (tenecteplase) approved by the FDA?

Yes. The FDA approved the application for TNKase (tenecteplase) on February 28, 2025, per the FDA's own record. The company announced it on March 3, 2025. The primary source is linked on this page.

What was TNKase (tenecteplase) under FDA review for?

The application covered Acute ischemic stroke (AIS) in adults. The FDA approved the application on March 3, 2025.

How did RHHBY stock react to the FDA decision?

On the decision day RHHBY moved +0.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.