Upcoming FDA decision · March 10, 2027
NTLA-2002 PDUFA date: FDA decision expected March 10, 2027
145 days to goIntellia Therapeutics, Inc. (NTLA) →
The FDA is expected to decide on NTLA-2002 from Intellia Therapeutics, Inc. in hereditary angioedema (“HAE”) by the PDUFA target action date of March 10, 2027. For hereditary angioedema (“HAE”). 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 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
March 10
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for NTLA-2002?
- The FDA's PDUFA target action date for NTLA-2002 is March 10, 2027. The FDA can act before that date, and the review can be extended.
- What is NTLA-2002 being reviewed for?
- The application under FDA review covers hereditary angioedema (“HAE”).
- Which company is developing NTLA-2002?
- Intellia Therapeutics, Inc. (NTLA).
- 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).