Nogapendekin alfa inbakicept PDUFA date: FDA decision expected January 6, 2027
The FDA is expected to decide on Nogapendekin alfa inbakicept from ImmunityBio, Inc. in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without CIS by the PDUFA target action date of January 6, 2027. For BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without CIS. sNDA filing. Extracted from SEC filing: EX-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.
Questions about this FDA decision
- When is the PDUFA date for Nogapendekin alfa inbakicept?
- The FDA's PDUFA target action date for Nogapendekin alfa inbakicept is January 6, 2027. The FDA can act before that date, and the review can be extended.
- What is Nogapendekin alfa inbakicept being reviewed for?
- The application under FDA review covers BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without CIS.
- Which company is developing Nogapendekin alfa inbakicept?
- ImmunityBio, Inc. (IBRX).
- 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).