Category IBRX

ImmunityBio Inc

ImmunityBio (IBRX): from the FDA advertising warning to the company’s fix plan, lawsuit noise, and stronger early Q1 revenue

IBRX APRIL

This update picks up the story where the earlier Merlintrader pieces left it: global expansion, label-expansion ambition and clinical momentum were still moving forward, but the market narrative suddenly shifted when the FDA’s Office of Prescription Drug Promotion publicly challenged how ANKTIVA had been promoted. The key question now is not whether the issue existed — it did — but whether the company’s remediation plan is enough to contain the damage while the underlying commercial story keeps improving.

ImmunityBio Inc ( $IBRX ) today’s NK-cell manufacturing milestone is real

Today’s official release from ImmunityBio was about cell-manufacturing execution, not about ANKTIVA sales, not about a fresh FDA approval, and not about a pivotal top-line readout. The company said it has completed manufacturing engineering programs that established a reproducible leukapheresis-to-manufacturing pathway for its autologous M-ceNK platform. In simple English, ImmunityBio is telling the market that it has moved another step from “interesting immunology concept” toward “repeatable cell-therapy process that can be run at scale.”

ImmunityBio (NASDAQ: IBRX) — FDA resubmission

What happened today
Today’s real headline is straightforward: ImmunityBio announced that it has resubmitted the supplemental biologics license application to the FDA for ANKTIVA plus BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

According to the company, it had already submitted information requested by the FDA in February 2026, but in March the agency then requested updated efficacy information based on longer follow-up, which ImmunityBio says has now been included in the resubmitted package.

ImmunityBio Inc ($IBRX) Update Feb 20

ImmunityBio announced a commercial partnership with Biopharma and Cigalah Healthcare to launch ANKTIVA in Saudi Arabia and, over time, across the wider Middle East and North Africa, backed by an SFDA registration certificate with pricing. It’s not a new label approval, but it is a concrete step in the global monetization of the ANKTIVA franchise.

ImmunityBio Inc ($IBRX) ANKTIVA in EU Ok!

European Commission Grants Final Conditional Marketing Authorization for ANKTIVA® in EU
Decision C(2026)1197: Final, binding authorization allowing commercial launch across 27 EU member states + Iceland, Norway, Liechtenstein for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

ImmunityBio Inc $IBRX

Potential resubmission of the supplemental BLA for BCG-unresponsive papillary NMIBC following the January 20 FDA meeting. The company committed to deliver additional analyses within 30 days, without new clinical trials. If the resubmission is accepted, the review clock could define the next major run-up window.

IBRX ImmunityBio Inc Update Jan 31

Since the last Merlintrader pieces on ImmunityBio, the story has accelerated on several fronts. Anktiva net product revenue exploded to a preliminary 113 million dollars for 2025, a roughly 700 percent year-over-year jump with 38.3 million in the fourth quarter alone, backed by strong unit growth and broader coverage in the United States and abroad, as detailed in the company’s mid-January 2026 update and echoed across financial coverage.

IBRX ImmunityBio

Over the last few weeks ImmunityBio has done pretty much everything a biotech can do to light up screens: big revenue jump, new regulatory approvals and sexy cell-therapy data. The stock has reacted exactly the way you would expect in a heavily shorted name – vertical move, news sites still talking about it days later, social media on fire.

In this piece we are going to do something boring but necessary: stack all the verifiable positives (with links), then put them next to the very real risks. Only at the end we’ll talk about the “everybody is still pushing this story” part and why that’s exactly the moment when you want to cool your head.

IBRX – CGON – ENGN – NMIBC bladder-sparing race

igh-risk non-muscle-invasive bladder cancer after failure of BCG has become one of the hottest oncology niches of 2025–2026. ImmunityBio with ANKTIVA is already on the market, while CG Oncology and enGene are coming fast with late-stage programs. This report compares mechanisms, clinical data, timelines and sentiment, so traders can look beyond the single name that is dominating the headlines in these weeks.

IBRX ImmunityBio Inc

On December 12, 2025, the European Medicines Agency recommended granting a conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with CIS, with or without papillary tumors – effectively mirroring the U.S. label in the EU and leveraging the pivotal QUILT-3.032 data set.