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Home › FDA Decisions › RHHBY 2025-10-02

RHHBY FDA Decision Approved · 2025-10-02

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/2/25$44.83$36.864/17/25
Daily close, T-120 (4/17/25) through T+5. Run-up high $44.83 on 10/1/25, low $36.86 on 4/17/25 (T-120 to T-1). FDA decision 10/2/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-10-02
DrugZepzelca (lurbinectedin) and Atezolizumab (Tecentriq)
IndicationFirst-line, Small Cell Lung Cancer (SCLC)
Outcome✓ Approvedprimary-sourced
Decision-day move-0.3%
T-120 run-up (low→high)+11.0% ($37.57→$45.3)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA213702, action date 2025-10-02
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 Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) approved by the FDA?

Yes. The FDA approved the application for Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) on October 2, 2025. The primary source is linked on this page.

What was Zepzelca (lurbinectedin) and Atezolizumab (Tecentriq) under FDA review for?

The application covered First-line, Small Cell Lung Cancer (SCLC). The FDA approved the application on October 2, 2025.

How did RHHBY stock react to the FDA decision?

On the decision day RHHBY moved -0.3%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.