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 positive long-term results from its QUILT-3.032 study of ANKTIVA® plus BCG for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The study showed:
For CIS with/without papillary disease (N=100):
- 71% complete response rate with responses up to 53+ months
- 84.2% cystectomy avoidance rate at 36 months
- 99% disease-specific survival rate at 36 months
For papillary disease without CIS (N=80):
- 58.2% disease-free survival rate at 12 months
- 82% cystectomy avoidance rate at 36 months
- 96% disease-specific survival rate at 36 months
The treatment was well-tolerated with mostly grade 1-2 adverse events. ImmunityBio has submitted a supplemental BLA to FDA for ANKTIVA plus BCG in BCG-unresponsive NMIBC papillary disease indication.
ImmunityBio (NASDAQ: IBRX) will present new clinical findings for ANKTIVA® in non-muscle invasive bladder cancer at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29. The company will showcase updates from the QUILT-3.032 trial, demonstrating long-term efficacy data for ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS.
Key presentations include an oral session on complete responses to ANKTIVA plus BCG therapy, and keynote events by Dr. Patrick Soon-Shiong discussing innovation in urological cancers. The company has submitted a Supplemental Biologics License Application for BCG unresponsive NMIBC and applied for Expanded Access Authorization of ANKTIVA as a BioShield for patients receiving chemotherapy, radiation, and immunotherapy.
ImmunityBio (NASDAQ: IBRX) has made significant regulatory and commercial progress in Q1 2025. The company submitted a supplemental Biologics License Application (sBLA) for ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for papillary disease indication. Clinical data showed 88% and 82% probability of avoiding bladder removal at 2 and 3 years respectively.
The company also submitted an Expanded Access Protocol (EAP) for ANKTIVA to treat lymphopenia, following a Regenerative Medicine Advanced Therapy (RMAT) designation. Commercially, with a permanent J-code (J9028) awarded in January 2025, Q1 2025 saw strong growth with:
- Net product revenue of $16.5M, up 129% from Q4 2024's $7.2M
- ANKTIVA unit sales volume increased 150% over Q4 2024
- March sales volume grew 69% compared to February 2025
ImmunityBio (NASDAQ: IBRX) has secured a $75 million equity financing through a registered direct offering with a single institutional investor. The agreement includes the issuance of common stock and warrants for additional share purchases. If the warrants are fully exercised, they could generate up to approximately $90 million in additional gross proceeds.
The securities will be offered under the company's automatic shelf registration statement on Form S-3, with a final prospectus supplement to be filed with the SEC. The financing aims to provide working capital and support ongoing business operations.
ImmunityBio (NASDAQ: IBRX) has announced an Investor Day program scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will feature comprehensive updates on:
- Business operations and regulatory advances
- Clinical programs including bladder cancer, non-small cell lung cancer, and metastatic pancreatic cancer trials
- Natural killer (NK) cell therapy program and Lynch syndrome accrual
- Discussions on virally induced cancers and Long-COVID
The event will include fireside chats with distinguished key opinion leaders and a presentation by Dr. Patrick Soon-Shiong on the company's technology platforms. The in-person event will be held in El Segundo, California, with space availability, requiring advance RSVP. A live stream option will be available for remote attendance.
ImmunityBio (NASDAQ: IBRX) has announced an upcoming Investor Day scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will be hosted at their El Segundo, California facilities, offering both in-person attendance and live streaming options.
The program will feature comprehensive updates on business operations and R&D progress, including presentations from CEO Richard Adcock and Founder Dr. Patrick Soon-Shiong. Key highlights will include:
- Discussion of product candidate timelines and ongoing clinical trials
- Detailed overview of the company's technology platforms
- Presentation on ANKTIVA, their initial therapeutic
- Tour of manufacturing facilities demonstrating production capabilities
The company's focus remains on developing a Therapeutic BioShield across multiple tumor types, leveraging their innovative approach to immunology for long-term disease protection and prevention.
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.