Upcoming FDA decision · November 30, 2026
ZL-1310 PDUFA date: FDA decision expected November 30, 2026
43 days to goZai Lab Limited (ZLAB) →
The FDA is expected to decide on ZL-1310 from Zai Lab Limited in schizophrenia in adults by the PDUFA target action date of November 30, 2026. For schizophrenia in adults. bla filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 30
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for ZL-1310?
- The FDA's PDUFA target action date for ZL-1310 is November 30, 2026. The FDA can act before that date, and the review can be extended.
- What is ZL-1310 being reviewed for?
- The application under FDA review covers schizophrenia in adults.
- Which company is developing ZL-1310?
- Zai Lab Limited (ZLAB).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).