EGTX
Emcitate (tiratricol)
FDA PDUFA Target Action Date · Egetis Therapeutics AB
Monday, September 28, 2026
Approved
approved Note: Approved 2026-09-28 as EMCITATE (ORIG NDA220963). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Drug Information
- Drug Name
- Emcitate (tiratricol) (CT.gov)
- Application Type
- NDA
- FDA Designations
- Priority ReviewOrphan DrugFast TrackBreakthroughRare Pediatric Disease
- Indication
- MCT8 deficiency (monocarboxylate transporter 8 deficiency)
- Approved As
- Emcitate (tiratricol)
Filing Details
- Company
- Egetis Therapeutics AB
- Stock Ticker
- EGTX
- Source
- company press release →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue