Upcoming FDA decision · October 26, 2026
BIIB080 PDUFA date: FDA decision expected October 26, 2026
8 days to goIonis Pharmaceuticals, Inc. (IONS) →
The FDA is expected to decide on BIIB080 from Ionis Pharmaceuticals, Inc. by the PDUFA target action date of October 26, 2026. Extracted from SEC filing: EXHIBIT 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.
October 26
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for BIIB080?
- The FDA's PDUFA target action date for BIIB080 is October 26, 2026. The FDA can act before that date, and the review can be extended.
- Which company is developing BIIB080?
- Ionis Pharmaceuticals, Inc. (IONS).
- 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).