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RHHBY FDA Decision Approved · 2025-12-22

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 (7/7/25) through T+5. Run-up high $51.22 on 12/15/25, low $37.57 on 8/13/25 (T-120 to T-1). FDA decision 12/22/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-12-22

DrugLunsumio VELO (mosunetuzumab-axgb)

IndicationFollicular Lymphoma

Outcome✓ Approvedprimary-sourced

Decision-day move+0.4%

T-120 run-up (low→high)+29.0% ($39.58→$52.59)

ValidationVerified 2026-08-12: Drugs@FDA, application BLA761263, action date 2025-12-19

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 Lunsumio VELO (mosunetuzumab-axgb) approved by the FDA?

Yes. The FDA approved the application for Lunsumio VELO (mosunetuzumab-axgb) on December 19, 2025, per the FDA's own record. The company announced it on December 22, 2025. The primary source is linked on this page.

What was Lunsumio VELO (mosunetuzumab-axgb) under FDA review for?

The application covered Follicular Lymphoma. The FDA approved the application on December 22, 2025.

How did RHHBY stock react to the FDA decision?

On the decision day RHHBY moved +0.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.