Aankondiging • Jul 30

ImmunityBio Receives United Arab Emirates Marketing Authorization For ANKTIVA Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer And Metastatic Non-Small Cell Lung Cancer

ImmunityBio, Inc. has granted Marketing Authorization for ANKTIVA® (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. The UAE authorization further expands ANKTIVA’s global regulatory footprint to 34 countries. The BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) authorization is the first worldwide to span the full spectrum of BCG-unresponsive disease: carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS. The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) granted Marketing Authorization for two ANKTIVA presentations, the broadest approval to date for ANKTIVA including papillary disease and CIS in non-muscle invasive bladder cancer and non-small cell lung cancer in patients who failed checkpoint inhibitors and chemotherapy. Each approval covers a distinct indication: ANKTIVA 0.4 mg/0.4 mL (solution for intravesical instillation) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg/0.6 mL (solution for subcutaneous injection) in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). NMIBC evidence (QUILT-3.032): in the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61,80), with duration of complete response extending beyond 54 months; in the papillary-only cohort (N=80), 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a cystectomy free rate at 36-months of 83%. In the NSCLC indication, ANKTIVA plus a checkpoint inhibitor is authorized for adult patients with metastatic disease that progressed on or after standard of care including checkpoint failure. NSCLC evidence (QUILT-3.055): in checkpoint-refractory advanced NSCLC (N=79), median overall survival was 14.6 months (95% CI: 12.0, 19.5), with subjects of mean on-treatment ALC = 1,000 achieving of median OS of 16.2 months (95% CI: 13.8, 22.0). Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS. BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option. Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy. NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825). CIS with or without Papillary Disease (QUILT-3.032, Cohort A): In the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61, 80). Median duration of complete response (DoR), months (95% CI) (n=71) was 26.6 (13.0, 49.9). Range in months was 0.0, 54+ months. % (n) with CR at 12 months was 66% (47/71). % (n) with CR at 24 months was 42% (30/71). Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months. Disease-Free Survival (DFS) Rate at 12 Months (95% CI) was 58.2% (46.6, 68.2). Median Disease-Free Survival (DFS), months (95% CI) was 25.3 (9.8, 33.5). Cystectomy-Free Rate at Month 12 (95% CI) was 92.2% (83.4, 96.4). Rate at Month 18 (95% CI) was 87.9% (78.0, 93.5). Rate at Month 24 (95% CI) was 87.9% (78.0, 93.5). Rate at Month 36 (95% CI) was 83.1% (70.8, 90.5). In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported. NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). Number of deaths was 58 (73%). Median OS (months) was 14.6. 95% CI for the Median OS was 12.0, 19.5. Overall survival (OS) rate at Month 12 was 61.4% (49.5, 71.4). Overall survival (OS) rate at Month 24 was 29.8% (19.8, 40.4). In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%). The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates.

Aankondiging • Mar 10

ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data

ImmunityBio announced that the U.S. Food and Drug Administration has acknowledged receipt of its supplemental Biologics License Application for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing. The long-term safety and efficacy results for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors have been published in The Journal of Urology. The sBLA aims to address the unmet need for patients with papillary-only NMIBC, supported by what is believed to be the longest duration of follow-up and bladder preservation data in this patient population. Approximately 60,000 people are diagnosed with NMIBC annually in the U.S., with approximately 70% presenting with papillary (Ta) disease. Based on the IL-15 mechanism of action and results from the QUILT 3.055 study, the Saudi Food and Drug Authority recently approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer whose disease has progressed after standard therapies, including checkpoint inhibitor treatment. In this setting, multiple randomized studies of investigational agents compared with docetaxel chemotherapy have failed to demonstrate improved outcomes, underscoring the significant unmet need among patients who experience relapse or progression after checkpoint inhibitor therapy. Notably, the recent randomized PRAGMATICA-LUNG (SWOG S2302) trial in the same disease setting, which compared pembrolizumab plus ramucirumab versus docetaxel, did not demonstrate improved survival compared with docetaxel, reporting a median overall survival of approximately nine months with docetaxel chemotherapy. ImmunityBio plans to present the clinical data supporting the SFDA approval of the chemotherapy-free regimen of ANKTIVA plus checkpoint inhibitors, which demonstrated nearly double the median overall survival historically observed with docetaxel chemotherapy. The Company also intends to continue discussions with the FDA and other global regulatory authorities regarding potential treatment options for patients with second line and later metastatic NSCLC who have exhausted currently available standards of care, including checkpoint inhibitors. The sBLA submission for BCG-unresponsive NMIBC papillary disease is supported by long-term results from the QUILT 3.032 Phase 2/3 trial (Cohort B) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival rate of 58.2% (95% confidence interval: 46.6-68.2%). Patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival rate at 36 months, with median disease-specific survival not yet reached. Progression-free survival was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These results highlight the potential of ANKTIVA plus BCG to provide durable bladder-sparing outcomes and a chemotherapy-free immunotherapy alternative for patients with high-risk papillary NMIBC. The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company's BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with carcinoma in situ do not have a complete response to treatment after a second induction course of ANKTIVA with Bacillus Calmette-Guérin, reconsider cystectomy. For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Rente dekkingsratio	n/a
Contant	US$357.37m
Aandelen	-US$1.05b
Totaal verplichtingen	US$1.67b
Totaal activa	US$628.50m

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/08/07 17:59
Aandelenkoers aan het einde van de dag	2026/08/07 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Suranjit Mukherjee	BTIG
Justin Zelin	BTIG
Jason Kolbert	D. Boral Capital LLC.

ImmunityBio Balans Gezondheid

Financiële gezondheid criteriumcontroles 1/6

Belangrijke informatie

Recente financiële gezondheidsupdates

Recent updates

ImmunityBio Delivers Record Q2 Revenue and Secures Exclusive US Rights for Tokyo-172 BCG

Second quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind

ImmunityBio Secures UAE Approval for ANKTIVA in Bladder and Lung Cancer Indications

ImmunityBio Receives United Arab Emirates Marketing Authorization For ANKTIVA Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer And Metastatic Non-Small Cell Lung Cancer

IBRX: FDA Review Timeline For Bladder Cancer Will Drive Future Upside

ImmunityBio: Intriguing Progress, If Not (Yet) Commercially - Still A Hold

IBRX: Saudi Rollout And FDA Label Review Will Drive Future Upside

Independent Director notifies of intention to sell stock

ImmunityBio Launches Anktiva in Saudi Arabia With Market Watching July Updates

ImmunityBio, Inc.(NasdaqGS:IBRX) dropped from Russell 2500 Value Benchmark

IBRX: Potential Index Inclusion Will Support Cancer Franchise Expansion

ImmunityBio Presents Positive Phase 3 ANKTIVA Data in Lung and Bladder Cancer at ASCO 2026

Board Member notifies of intention to sell stock

ImmunityBio Presents Phase 3 Data for ANKTIVA in Lung and Bladder Cancer at ASCO 2026

Price target decreased by 17% to US$13.00

ImmunityBio Announces FDA Acceptance Of Supplemental BLA For ANKTIVA Plus BCG In BCG-Unresponsive Non-Muscle Invasive Bladder Cancer With Papillary Disease

Here's What Analysts Are Forecasting For ImmunityBio, Inc. (NASDAQ:IBRX) After Its First-Quarter Results

New major risk - Financial position

Forecast to breakeven in 2028

First quarter 2026 earnings released: US$0.62 loss per share (vs US$0.15 loss in 1Q 2025)

ImmunityBio, Inc., Annual General Meeting, Jun 09, 2026

ImmunityBio Announces Anktiva Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients

ImmunityBio Inc Addresses FDA Correspondence and Implements Enhanced Advertising Compliance Measures

Expanded Immunotherapy Platform And Automation Will Transform Long Term Earnings Power

ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA Plus BCG Versus BCG Alone

ImmunityBio, Inc. Announces Approval For ANKTIVA In Macau Sar China For Bcg-Unresponsive Nmibc With Cis ± Papillary Tumors

Single Asset Dependence And Regulatory Hurdles Will Gradually Give Way To Broader Platform Potential

Immunitybio Announces NCCN Clinical Practice Guidelines in Oncology Have Been Updated to Include Anktiva Plus BCG for Patients with BCG-Unresponsive NMIBC with Papillary-Only Disease

ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from over 60 Healthy and Cancer Donors

ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data

Forecast breakeven date moved forward to 2027

Global Immunotherapy Expansion And AI Automation Will Reshape Long Term Prospects

ImmunityBio, Inc. Completes Enrollment in Pivotal Randomized Trial Evaluating ANKTIVA®? Plus BCG Versus BCG Alone in BCG-Naive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

President exercised options and sold US$675k worth of stock

New major risk - Financial position

Full year 2025 earnings: EPS exceeds analyst expectations

ImmunityBio Receives Authorization from the European Commission for ANKTIVA with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 Countries

ImmunityBio, Inc. Reports Productive Regulatory Engagement with Saudi Food and Drug Authority At USA -Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia

President exercised options and sold US$971k worth of stock

ImmunityBio, Inc. Launches Phase 2 Chemotherapy-FreeCAR-NK Cell Therapy Trial with Anktiva (ResQ215B) in Indolent Lymphomas

ImmunityBio, Inc. Reports Median Overall Survival Not Yet Reached and Lymphopenia Reversed in Recurrent Glioblastoma Patients Receiving ANKTIVA Plus CAR-NK, Chemo-Free Therapy

Price target increased by 9.6% to US$11.40

Board Member notifies of intention to sell stock

Immunitybio Advances Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer

Consensus estimates of losses per share improve by 10%

ImmunityBio Advances First-Line BCG Naive NMIBC Program with Enrollment Exceeding Expectations and Positive Interim Analysis for ANKTIVA® Plus BCG

New minor risk - Share price stability

Saudi Fda Grants Accelerated Approval to ImmunityBio , Inc.'s Anktiva for Non-Muscle Invasive Bladder Cancer Witharcinoma In-Situ

ImmunityBio, Inc. Announces Positive Results Demonstrating ANKTIVA as a Lymphocyte Stimulating Agent in Combination with Checkpoint Inhibitors in Non-Small Cell Lung Cancer

Forecast to breakeven in 2028

ImmiBio, Inc. Announces Treatment with ANKTIVA®? (nogapendekin Alfa Inbakicept-pmln) Plus Bacillus Calmette-Guerin

ImmunityBio, Inc. Appoints Bruce Wendel to the Board, Effective December 12, 2025

Immunitybio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for Anktiva with Bcg for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

New minor risk - Financial position

Third quarter 2025 earnings: EPS exceeds analyst expectations

New minor risk - Profitability

ImmunityBio, Inc. Announces its ANKTIVA Reverses Lymphopenia and Extends Overall Survival in Patients with Advanced Non-Small Cell Lung Cancer Resistant to Checkpoint Therapy

ImmunityBio, Inc. Announces Initial Data Shows 100% Disease Control in 5 Out of 5 Patients with Recurrent Glioblastoma with Two Patients in Near Complete Response Treated with Immunotherapy's ANKTIVA®?, NK Cell Therapy Plus Optune Gio®? Device

ImmunityBio, Inc. Announces Phase 2 Study of ANKTIVA®? in Patients with Long COVID

Price target decreased by 16% to US$10.20

Immunitybio Reports Complete Responses in Non-Hodgkin Waldenstrom Lymphoma Patients with Chemotherapy-Free

ImmunityBio, Inc. Announces Houston's Michael E. DeBakey Department of Veterans Affairs Medical Center Is Among the First VA Hospitals to Helpister ANKTIVA to Bladder Cancer Patients

No longer forecast to breakeven

Second quarter 2025 earnings: EPS and revenues exceed analyst expectations

ImmunityBio, Inc. has filed a Follow-on Equity Offering in the amount of $80 million.

UK MHRA Approves ImmunityBio’s ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Immunitybio, Inc. Receives Fda Expanded Access Authorization for Landmark Treatment of Lymphopenia with Anktiva, the Cancer Bioshield™ Platform, in Patients with Solid Tumors

First quarter 2025 earnings: EPS misses analyst expectations

ImmunityBio, Inc. Receives Refusal to File Letter from the U.S. Food and Drug Administration for the Supplemental Biologics License Application

ImmunityBio, Inc., Annual General Meeting, Jun 18, 2025

ImmunityBio Q1 Earnings Preview: I Fear A Selloff, But Am Long-Term Bullish

ImmunityBio, Inc. Announces Positive Long-Term Results from Its Quilt-3.032 Study of Anktiva® (Nogapendekin Alfa Inbakicept-Guerin) Plus BCG

New major risk - Shareholder dilution

ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA to Treat Lymphopenia

ImmunityBio, Inc. has filed a Follow-on Equity Offering in the amount of $75.000001 million.