ONC FDA decision — May 13, 2026
✓ 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 $274.73 11/26/25 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 date 2026-05-13
Outcome Approved
Drug / candidate BEQALZI (Sonrotoclax)
Company BeOne Medicines Ltd.
120-day run-up (T-120→T-1) -13.4%
Not affiliated with or endorsed by the FDA. Informational and educational only — not investment advice. Verify against primary FDA / SEC / company filings. © 2026 pdufa.bio