Immunitybio Inc Stock Price, News & Analysis

ImmunityBio (NASDAQ: IBRX) has initiated dosing of recombinant BCG (rBCG) in the U.S. through its FDA-authorized Expanded Access Program (EAP). U.S. Urology Partners is among the first providers to offer this alternative BCG treatment, with 60 sites preparing for launch.

The program addresses critical TICE® BCG shortages affecting bladder cancer treatment nationwide. A recent survey of 100 U.S. urologists revealed that 57% couldn't treat patients in the past year due to BCG access issues.

The rBCG, manufactured by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG formulations. The EAP is being managed by Anova Enterprises, Inc., providing an essential alternative source for this standard-of-care treatment in bladder cancer.

ImmunityBio (NASDAQ: IBRX) reported strong growth following its ANKTIVA product's permanent J-code issuance in January 2025. February 2025 unit sales volume increased 97% compared to December 2024, with a 67% month-over-month growth from January 2025.

Key financial highlights include Q4 2024 net product revenue of $7.2 million, a 21% increase from Q3's $6.0 million. The company's cash position stood at $149.8 million as of December 31, 2024. Annual net loss decreased to $413.6 million in 2024 from $583.2 million in 2023.

Notable developments include:

• FDA authorization for expanded access to alternative BCG source with 45,000 doses available
• MHRA and EMA acceptance of marketing authorization applications for ANKTIVA
• RMAT designation for ANKTIVA and CAR-NK combination therapy
• BeOne Medicines collaboration for Phase 3 NSCLC trial

ImmunityBio (NASDAQ: IBRX) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA® and CAR-NK therapy. This designation covers two key applications: reversing lymphopenia in patients receiving standard chemotherapy/radiotherapy, and treating multiply relapsed locally advanced or metastatic pancreatic cancer.

The designation follows clinical data from QUILT trials showing significant correlations between Absolute Lymphocyte Count (ALC) and Overall Survival (OS) across multiple tumor types. ANKTIVA has demonstrated ability to proliferate and activate NK cells, CD4+ T cells, CD8+ T cells, and memory T cells without increasing suppressive T regulatory cells.

The company plans to submit a Biologic License Application (BLA) for both indications and will provide data from fully enrolled clinical trials in metastatic pancreatic cancer (QUILT-88) and checkpoint relapsed NSCLC (QUILT-3.055). Additionally, ImmunityBio will file an Expanded Access Policy (EAP) for ANKTIVA and PD-L1 t-haNK in combination with standard care within 15 days.

ImmunityBio (NASDAQ: IBRX) has received FDA authorization for an expanded access program (EAP) to provide recombinant BCG (rBCG), addressing the critical shortage of TICE® BCG for bladder cancer treatment in the US. The alternative BCG source, developed by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity and improved safety compared to earlier BCG strains.

A recent Sermo survey revealed that 57% of US urologists were unable to treat patients in the last 12 months due to TICE® BCG shortage. The company has thousands of vials ready for immediate shipment, potentially resolving this significant treatment impediment. The rBCG has completed Phase 2 clinical trials in Europe for non-muscle invasive bladder cancer (NMIBC).

ImmunityBio (NASDAQ: IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA®. The application is for ANKTIVA® in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

This acceptance follows the European Medicines Agency's recent review acceptance for 30 EU countries and comes 10 months after FDA approval in the United States. The MHRA will now begin assessing the marketing authorization application for potential approval in the UK market.

ImmunityBio (NASDAQ: IBRX) has partnered with BeiGene to conduct a confirmatory Phase 3 trial combining BeiGene's tislelizumab (PD-1 checkpoint inhibitor) with ImmunityBio's ANKTIVA in non-small cell lung cancer (NSCLC). The trial builds on the QUILT 3.055 Phase 2 results, which showed prolonged overall survival in second and third-line NSCLC patients who progressed on checkpoint inhibitor therapies.

The Phase 3 ResQ201A-NSCLC study will include 462 participants and aims to confirm the efficacy demonstrated in QUILT 3.055, where median overall survival reached 14.1 months. ANKTIVA, an IL-15 superagonist, has shown the ability to rescue T cells and restore checkpoint inhibitor efficacy through its unique mechanism of action. ImmunityBio plans to submit a biologics license application (BLA) in 2025 for this indication.

ImmunityBio (NASDAQ: IBRX) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application for ANKTIVA® in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

The application covers 30 European countries and is based on the ongoing QUILT 3.032 study, which demonstrated a 71% complete response rate in 100 patients. The duration of response ranges up to 54 months and is ongoing, surpassing the duration of response of all approved products for this indication. This milestone comes nine months after FDA approval in the United States.

The company has also submitted an application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The study results exceed the International Bladder Cancer Group's benchmark of 18 months for meaningful clinical results.

ImmunityBio (NASDAQ: IBRX) has submitted marketing authorization applications for ANKTIVA® plus BCG treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ to both the European Medicines Agency (EMA) and UK's Medicines and Healthcare products Regulatory Agency (MHRA).

The submissions were completed in December 2024 for EMA and November 2024 for MHRA, with assessments expected to be completed by Q4 2025. The EMA application covers 27 EU countries plus Iceland, Norway, and Liechtenstein. Potential approval in both regions could come by 2026.

In the US, ANKTIVA's launch has progressed well, with the treatment now widely accessible through commercial and government insurance programs covering over 240 million lives. The product has received a permanent HCPCS J-code (J9028) from CMS for intravesical use.

ImmunityBio (NASDAQ: IBRX) announces plans for three FDA submissions in 2025: a supplemental BLA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in papillary indication, a regulatory submission for an alternative BCG source in partnership with Serum Institute of India, and a BLA for second- and third-line non-small cell lung cancer (NSCLC) treatment.

For NMIBC, clinical data showed a 55% disease-free rate at 12 months and 93% cystectomy avoidance. The QUILT-3.055 Phase 2b study for NSCLC (N=86) demonstrated 14.1 months median overall survival for all patients, extending to 15.8 months in PD-L1 negative subjects, comparing favorably to standard docetaxel treatment's 7-10 months survival rate.