Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
BEQALZI (Sonrotoclax) was approved by the FDA on May 13, 2026 to treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor, the 14th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
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.
FDA record of the action: the FDA approved on May 13, 2026, per NDA 220711 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding ONC, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was BEQALZI (Sonrotoclax) approved by the FDA?
Yes. The FDA approved the application for BEQALZI (Sonrotoclax) on May 13, 2026, per the FDA's own record. 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 FDA's own record of the decision 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.
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