Welcome to our dedicated page for Immunitybio news (Ticker: IBRX), a resource for investors and traders seeking the latest updates and insights on Immunitybio stock.
ImmunityBio, Inc. (NASDAQ: IBRX) generates frequent news as a commercial-stage biotechnology company centered on IL‑15–based immunotherapies and cell therapies. Its updates often highlight clinical data, regulatory milestones, and commercial performance for ANKTIVA, an IL‑15 receptor agonist fusion complex that the company describes as a key component of its BioShield platform.
News coverage commonly focuses on bladder cancer and non‑small cell lung cancer (NSCLC). For non‑muscle invasive bladder cancer, ImmunityBio reports results from the QUILT‑3.032 trial of ANKTIVA plus BCG in BCG‑unresponsive disease, including data on disease‑specific survival, progression‑free survival, and cystectomy avoidance. For NSCLC, press releases describe findings from QUILT‑2.023 and QUILT‑3.055, where ANKTIVA combined with checkpoint inhibitors has been associated with immune restoration, measured by absolute lymphocyte count, and linked to survival outcomes in checkpoint‑experienced patients.
Regulatory developments are another major news theme. Recent announcements include a conditional marketing authorization recommendation from the European Medicines Agency for ANKTIVA plus BCG in BCG‑unresponsive NMIBC CIS, as well as Saudi Food and Drug Authority approvals for ANKTIVA plus BCG in NMIBC CIS and for ANKTIVA in combination with checkpoint inhibitors in metastatic NSCLC, including the first approval for subcutaneous administration. These items illustrate how ImmunityBio’s news flow tracks the global expansion of ANKTIVA‑based regimens.
Investors and observers can also expect news on financial results and product revenue, particularly net product revenue and unit growth for ANKTIVA, along with cash position and capital‑raising activities disclosed in earnings releases and related Form 8‑K filings. Additional stories cover early data in glioblastoma using ANKTIVA plus NK cell therapy and the Optune Gio device, initiatives in non‑Hodgkin lymphoma and other cancers, and participation in forums such as the U.S.–Saudi Biotech Alliance Summit.
By following ImmunityBio’s news page, readers can track clinical trial progress, new approvals, and commercial trends that shape the outlook for IBRX and its IL‑15–based immunotherapy programs.
ImmunityBio (NASDAQ: IBRX) announced breakthrough findings from its Phase 2 QUILT-3.055 study of ANKTIVA® in treating advanced non-small cell lung cancer (NSCLC) patients resistant to checkpoint therapy. The study demonstrated that ANKTIVA successfully reversed lymphopenia in 80% of patients, maintaining absolute lymphocyte count (ALC) above 1,000 cells/µL.
Key results showed median overall survival of 21.1 months in patients with ALC counts greater than 1,500 cells/µL, significantly surpassing the historical 7-9 months survival with docetaxel. The company is now conducting a Phase 3 ResQ201A trial evaluating ANKTIVA + tislelizumab versus docetaxel alone in second-line NSCLC patients.
ImmunityBio (NASDAQ: IBRX) has reported promising initial results from its pilot study combining ANKTIVA®, NK cell therapy, and Optune Gio® device in treating recurrent glioblastoma (GBM). The trial showed 100% disease control in all 5 patients, with 3 patients responding to treatment, including 2 achieving near complete response, and 2 maintaining stable disease.
The chemotherapy-free treatment demonstrated significant efficacy in increasing absolute lymphocyte count in all patients who had previously experienced lymphopenia after standard care. Based on these encouraging results, ImmunityBio is planning to initiate a Phase 2 randomized trial for second-line GBM patients.
This development is particularly significant as GBM affects approximately 12,000 Americans annually and has one of the lowest five-year survival rates among brain tumors - just 9% for patients aged 45-54 and 6% for ages 55-64.
ImmunityBio (NASDAQ: IBRX) has launched a new Phase 2 study to evaluate ANKTIVA® in patients with long COVID. The study, dubbed COVID-4.019-Long (NCT07123727), aims to assess the safety and efficacy of ANKTIVA in addressing long COVID symptoms, which affect approximately one in five American adults who had COVID-19.
The single-arm study will recruit up to 40 participants and evaluate ANKTIVA's ability to improve natural killer (NK) cell and CD8+ T cell counts. The drug is currently FDA-approved for bladder cancer treatment and is being studied across multiple cancer indications, HIV, and lymphopenia.
ImmunityBio (NASDAQ: IBRX) reported promising results from its QUILT-106 Phase I trial evaluating CD19 CAR-NK cell therapy in patients with Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma. The study demonstrated complete responses in the first two treated patients with late-stage WM using a chemotherapy-free immunotherapy approach.
The trial, conducted across three sites in South Africa, has enrolled 13 NHL patients, including three with WM. One patient achieved complete response with CD19 CAR-NK monotherapy, while another maintained complete response for six months using CD19 CAR-NK combined with rituximab. Notably, all treatments were administered in an outpatient setting with no significant toxicities reported.
ImmunityBio (NASDAQ: IBRX) announced that Houston's Michael E. DeBakey VA Medical Center has become one of the first VA hospitals in the United States to administer ANKTIVA® to veterans with bladder cancer. The treatment, recently FDA-approved, combines ANKTIVA with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
This development is particularly significant as a 2024 study revealed veterans face higher bladder cancer risks due to military exposure to carcinogenic agents. The initiative was led by urologic oncologists Dr. Jeffrey Jones and Dr. Jennifer Taylor, who were instrumental in bringing this treatment to veterans and enrolling the facility in ImmunityBio's Expanded Access Program for rBCG.
ImmunityBio (NASDAQ: IBRX) reported strong Q2 2025 financial results, with revenue reaching $26.4 million, a 60% increase from Q1 2025. Year-to-date sales reached $43 million, with ANKTIVA unit sales volume growing 246% in 1H 2025 compared to 2H 2024.
The company's financial position shows $153.7 million in cash and equivalents as of June 30, 2025, bolstered by an additional $80 million equity financing in July 2025. Despite revenue growth, the company reported a net loss of $92.6 million in Q2 2025, an improvement from the $134.6 million loss in Q2 2024.
Key developments include the launch of ResQ201A trial for non-small cell lung cancer, progress in the lymphopenia program, and UK MHRA approval for ANKTIVA in bladder cancer treatment. The company is addressing FDA requirements regarding its papillary NMIBC program and evaluating regulatory strategy options.
ImmunityBio (NASDAQ: IBRX) has secured an $80 million registered direct offering through a securities purchase agreement with two institutional investors. The offering includes common stock and warrants for additional share purchases.
The warrants, if fully exercised, could generate up to $96 million in additional gross proceeds. Piper Sandler & Co. is serving as the exclusive placement agent for this offering, which is being conducted under ImmunityBio's automatic shelf registration statement on Form S-3.
ImmunityBio (NASDAQ: IBRX) reported strong Q2 2025 financial results and clinical progress. The company achieved revenue of $26.4 million, a 60% increase from Q1 2025, with year-to-date sales reaching $43 million. ANKTIVA® unit sales volume grew 246% in 1H 2025 compared to 2H 2024. The company maintained a solid cash position of $153.7 million.
Key developments include initiating the ResQ201A trial for lung cancer, receiving MHRA marketing authorization for ANKTIVA, and ongoing FDA discussions regarding papillary NMIBC following a Refuse-to-File decision. The company is evaluating regulatory strategies for papillary-only NMIBC and has applied to NCCN for guideline expansion. Additionally, the FDA showed support for the lymphopenia program with an active Expanded Access Program.
ImmunityBio (NASDAQ: IBRX) has received UK MHRA approval for ANKTIVA® in combination with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. This marks ANKTIVA's first marketing authorization outside the United States.
ANKTIVA, a first-in-class IL-15 agonist, works by activating and proliferating natural killer (NK) and T cells. The therapy demonstrated impressive clinical results, with some patients showing complete response duration exceeding 47 months in a trial of 77 evaluable patients. The treatment offers new hope for the 16,400 to 18,000 people diagnosed with NMIBC annually in the UK.
The company is also pursuing regulatory approval with the European Medicines Agency (EMA) to expand ANKTIVA's availability across the EU member states, Iceland, Norway, and Liechtenstein.