ImmunityBio Faces Class Action Lawsuit

Written by Emily J. Thompson, Senior Investment Analyst

Source: PRnewswire

Updated: May 08 2026

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IBRX-3.85%

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Source: PRnewswire

Class Action Initiation: Purchasers of ImmunityBio, Inc. securities between January 19 and March 24, 2026, have until May 26, 2026, to seek lead plaintiff status in a class action lawsuit alleging violations of the Securities Exchange Act of 1934, potentially exposing investors to significant losses.
False Statement Allegations: The lawsuit claims that ImmunityBio made false and misleading statements regarding its lead biologics product Anktiva, asserting it could make all NMIBC patients cancer-free long-term, a claim that has not been substantiated, which may undermine investor confidence.
FDA Warning Impact: On March 24, 2026, the FDA issued a warning letter to ImmunityBio's CEO, stating that promotional materials misbranded Anktiva, violating the Federal Food, Drug, and Cosmetic Act, leading to a 21% drop in stock price, directly impacting the company's financial health.
Law Firm Background: Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud and shareholder rights litigation, having recovered over $916 million for investors in 2025, demonstrating its significant strength and influence in securities class action lawsuits.

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Analyst Views on IBRX

Wall Street analysts forecast IBRX stock price to fall

3 Analyst Rating

3 Buy

0 Hold

0 Sell

Strong Buy

Current: 8.050

Low

5.00

Averages

7.33

High

9.00

Current: 8.050

Low

5.00

Averages

7.33

High

9.00

BTIG

Buy

downgrade

$13 -> $12

2026-05-08

Reason

BTIG

Price Target

$13 -> $12

AI Analysis

2026-05-08

downgrade

Buy

Reason

BTIG lowered the firm's price target on ImmunityBio to $12 from $13 and keeps a Buy rating on the shares after its Q1 results, reaffirming the $44.2M in ANKTIVA sales pre-announced last month - up 15% q/q and 168% y/y.

BTIG

Buy

initiated

$13

2026-03-11

Reason

BTIG

Price Target

$13

2026-03-11

initiated

Buy

Reason

BTIG assumed coverage of ImmunityBio with a Buy rating and $13 price target. The stock has had a strong start to 2026, rising 318% year-to-date driven by 700% y/y growth for ANKTIVA in the US, EU conditional marketing approval, and approval for NSCLC in Saudi Arabia, and the firm believes further share appreciation from here will be led by continued ANKTIVA commercial execution and label expansion, the analyst tells investors in a research note.

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About IBRX

Immunitybio, Inc. is a vertically integrated, clinical-stage biotechnology company developing therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. Using its applied science and platforms to treat cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies to reduce or eliminate the need for standard high-dose chemotherapy. Its platforms and their associated product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including NK cells, dendritic cells, and macrophages, as well as the adaptive immune system comprising B and T cells, in an orchestrated manner. Its platforms for the development of biologic product candidates include antibody-cytokine fusion proteins, vaccine vectors, and cell therapies. Its biologic commercial product candidate, Anktiva, is an IL-15 superagonist antibody-cytokine fusion protein.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

ImmunityBio's Bladder Cancer Therapy Application Accepted by FDA

1 day agoseekingalpha

FDA Application Acceptance: ImmunityBio's marketing application for its bladder cancer therapy Anktiva has been accepted by the FDA, marking a significant advancement in the company's efforts to expand its product label, which is expected to enhance its market competitiveness.
Target Action Date: The FDA has set January 6, 2027, as the target action date for this application, providing the company with a clear market timeline that could bolster investor confidence.
Patient Population Size: Approximately 80% of bladder cancer cases diagnosed annually in the U.S. are non-muscle-invasive bladder cancer (NMIBC), with about 85% of those patients having papillary disease, indicating a substantial potential market for this therapy.
Clinical Trial Results: The sBLA is supported by data from the QUILT 3.032 Phase 2/3 trial, which showed a 12-month disease-free survival rate of approximately 58% for patients with papillary-only NMIBC, providing strong backing for the FDA's acceptance.

ImmunityBio Seeks ANKTIVA Label Expansion for NMIBC

2 days agoNewsfilter

FDA Review Progress: The U.S. FDA has accepted ImmunityBio's supplemental Biologics License Application (sBLA) for ANKTIVA, aiming to expand its indication to include patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), with a decision expected by January 6, 2027, which could significantly increase treatment options.
Clinical Data Support: The sBLA submission is based on data from the QUILT-3.032 trial, showing a 12-month disease-free survival rate of 58.2% in 80 high-risk patients treated with ANKTIVA plus BCG, providing scientific justification for the indication expansion that may improve patient outcomes.
Expert Consensus Reinforcement: At the FDA workshop in May 2026, experts unanimously agreed that CIS and papillary disease are biologically the same, supporting the inclusion of papillary disease in existing treatment protocols, highlighting the urgent treatment needs for BCG-unresponsive patients and furthering the sBLA review.
Significant Market Potential: The expanded indication for ANKTIVA positions it as a crucial immunotherapy option for BCG-unresponsive patients, likely enhancing ImmunityBio's competitiveness in the bladder cancer treatment market and addressing the urgent needs of approximately 64,000 NMIBC patients diagnosed annually.