pdufa.bio
HomeDecisions › RHHBY 2026-02-20

RHHBY FDA decision — Feb 20, 2026

✓ APPROVED

Roche Holding AG ADR — CALQUENCE plus venetoclax · Chronic lymphocytic leukemia (CLL) and small lymph.

Run-up into the decision (T-120 → T+5)

PDUFA 2/20/26$60.1$39.599/5/25
Daily close, T-120 (9/5/25) through T+5. Run-up high $60.1 on 2/17/26, low $39.59 on 10/3/25 (T-120 to T-1). FDA decision 2/20/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-20
OutcomeApproved
Drug / candidateCALQUENCE plus venetoclax
CompanyRoche Holding AG ADR
120-day run-up (T-120→T-1)+44.8%