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RHHBY FDA decision: Feb 20, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

CALQUENCE plus venetoclax was approved by the FDA; the approval was announced on February 20, 2026.

Roche Holding AG ADR, CALQUENCE plus venetoclax.

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%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.