Quimilza PDUFA date: FDA decision expected December 12, 2026
The FDA is expected to decide on Quimilza from AnaptysBio, Inc. in generalized pustular psoriasis (GPP) by the PDUFA target action date of December 12, 2026. For generalized pustular psoriasis (GPP). 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 26, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Quimilza?
- The FDA's PDUFA target action date for Quimilza is December 12, 2026. The FDA can act before that date, and the review can be extended.
- What is Quimilza being reviewed for?
- The application under FDA review covers generalized pustular psoriasis (GPP).
- Which company is developing Quimilza?
- AnaptysBio, Inc. (ANAB).
- 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).