Upcoming FDA decision · November 25, 2026
Venglustat PDUFA date: FDA decision expected November 25, 2026
40 days to goSanofi (SNY) →
The FDA is expected to decide on Venglustat from Sanofi in Type 3 Gaucher disease by the PDUFA target action date of November 25, 2026. For Type 3 Gaucher disease. NDA, Priority Review. Verified against the company announcement on 2026-10-16.
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: biospace.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 25
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 Venglustat?
- The FDA's PDUFA target action date for Venglustat is November 25, 2026. The FDA can act before that date, and the review can be extended.
- What is Venglustat being reviewed for?
- The application under FDA review covers Type 3 Gaucher disease.
- Which company is developing Venglustat?
- Sanofi (SNY).
- 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).