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Home › FDA Decisions › RHHBY 2025-03-03

RHHBY FDA Decision Approved · 2025-03-03

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/3/25$42.04$34.249/16/24
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=835)

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 TNKase (tenecteplase) approved by the FDA?

Yes. The FDA approved the application for TNKase (tenecteplase) 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.