ImmunityBio (IBRX) catalysts

Upcoming FDA decisions and readouts we track for ImmunityBio, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 11 Sep 2026

FreeBioList tracks 1 upcoming catalyst for ImmunityBio (IBRX, listed on Nasdaq). It concerns ANKTIVA (nogapendekin alfa) plus BCG (BCG-unresponsive NMIBC with papillary disease).

First on the list: the PDUFA date for ANKTIVA (nogapendekin alfa) plus BCG (BCG-unresponsive NMIBC with papillary disease), dated 06 Jan 2027.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 11 Sep 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: IBRX
Next catalyst: 06 Jan 2027
Type: PDUFA date
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
ImmunityBio IBRX · Nasdaq	ANKTIVA (nogapendekin alfa) plus BCG	BCG-unresponsive NMIBC with papillary disease	06 Jan 2027 in 91d	PDUFA date	Verified	8-K exhibit 99.1 ↗	Yes
Notes — Filing states the FDA accepted the sBLA and "assigned a PDUFA target action date of January 6, 2027." Source: 8-K exhibit 99.1, filed 04 Aug 2026 · verified 11 Sep 2026

Companies working on related conditions

CG Oncology (CGON)Intermediate-risk non-muscle invasive bladder cancer; High-risk BCG-unresponsive NMIBC

Also due in Q1 2027

Arcutis Biotherapeutics (ARQT)PDUFA date for ZORYVE (roflumilast) cream 0.05%, 23 Feb 2027
Belite Bio (BLTE)PDUFA date for Tinlarebant, 12 Feb 2027
Intellia Therapeutics (NTLA)PDUFA date for Lonvoguran ziclumeran (lonvo-z), 10 Mar 2027
Cullinan Therapeutics (CGEM)PDUFA date for Zipalertinib, 27 Feb 2027
Dyne Therapeutics (DYN)PDUFA date for z-rostudirsen (DYNE-251), 21 Jan 2027
Apnimed (APMD)PDUFA date for AD109 (Oxnimbi), 28 Feb 2027