IBRX

ANKTIVA (nogapendekin alfa inbakicept-pmln) + BCG

FDA PDUFA Target Action Date · ImmunityBio, Inc.

Wednesday, January 6, 2027

182 days away

Drug Information

Drug Name: ANKTIVA (nogapendekin alfa inbakicept-pmln) + BCG (CT.gov)
Application Type: sBLA
Indication: BCG-unresponsive NMIBC with papillary disease (no CIS)

Filing Details

Company: ImmunityBio, Inc.
Stock Ticker: IBRX
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.

View FDA Calendar →

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