We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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Questions
When is BEQALZI (Sonrotoclax)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for BEQALZI (Sonrotoclax); 1 FDA decision is on record below.
What happened at BEQALZI (Sonrotoclax)'s most recent FDA decision?
On May 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Has BEQALZI (Sonrotoclax) been approved by the FDA?
Yes. The FDA approved an application for BEQALZI (Sonrotoclax) on May 13, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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