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ONC FDA decision: May 13, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

BeOne Medicines Ltd., BEQALZI (Sonrotoclax) · Relapsed or refractory (R/R) mantle cell lymphoma .

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

PDUFA 5/13/26$370.64$274.7311/26/25
Daily close, T-120 (11/26/25) through T+5. Run-up high $370.64 on 2/24/26, low $274.73 on 3/24/26 (T-120 to T-1). FDA decision 5/13/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-13
OutcomeApproved
Drug / candidateBEQALZI (Sonrotoclax)
CompanyBeOne Medicines Ltd.
120-day run-up (T-120→T-1)-13.4%

Questions

Was BEQALZI (Sonrotoclax) approved by the FDA?

Yes. The FDA approved the application for BEQALZI (Sonrotoclax) on May 13, 2026. The primary source is linked on this page.

Which company is behind BEQALZI (Sonrotoclax)?

BEQALZI (Sonrotoclax) is a BeOne Medicines Ltd. (ONC) program. The FDA decision came on May 13, 2026; the company's own announcement is linked on this page.

How did ONC stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), ONC moved -13.4%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.