ANKTIVA (N-803) is a ImmunityBio, Inc. program in BCG-unresponsive papillary NMIBC. Its PDUFA date is Jan 6, 2027, the FDA's goal date to complete review of the application. 1 FDA decision on record below. Every date links its source.
Indication under review: BCG-unresponsive papillary NMIBC. Sponsor: ImmunityBio, Inc. (IBRX). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is ANKTIVA (N-803)'s next FDA decision or readout?
ANKTIVA (N-803)'s PDUFA date is Jan 6, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at ANKTIVA (N-803)'s most recent FDA decision?
On Feb 19, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is ANKTIVA (N-803) used for?
In our records ANKTIVA (N-803) is under review or in development for BCG-unresponsive papillary NMIBC.
Who makes ANKTIVA (N-803)?
ImmunityBio, Inc. (IBRX).
Has ANKTIVA (N-803) been approved by the FDA?
Yes. The FDA approved an application for ANKTIVA (N-803) on Feb 19, 2025; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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