n.c.a. 177Lu-edotreotide (ITM-11)

FDA PDUFA Target Action Date · ITM Isotope Technologies Munich SE

Friday, August 28, 2026

51 days away

Drug Information

Drug Name: n.c.a. 177Lu-edotreotide (ITM-11) (CT.gov)
Application Type: NDA
Indication: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Filing Details

Company: ITM Isotope Technologies Munich SE
SEC CIK
Source: Company PR →

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.

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue