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

Rhea-AI Summary

ImmunityBio (NASDAQ: IBRX) resubmitted a supplemental BLA to the FDA on March 9, 2026 for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only tumors. The FDA acknowledged receipt after requesting additional efficacy and long-term follow-up data; no new trials were requested. The company cites published long-term safety and bladder-preservation data and also notes a separate SFDA approval for ANKTIVA combinations in metastatic NSCLC.

Positive

• FDA acknowledged receipt of IBRX sBLA resubmission
• No new clinical trials requested by FDA for resubmission
• Updated long-term follow-up and bladder-preservation data submitted
• Long-term safety/efficacy results published in The Journal of Urology
• SFDA approved ANKTIVA combinations for second-line metastatic NSCLC

Negative

• FDA previously requested additional data and updated efficacy information
• Papillary-only NMIBC indication not yet approved; sBLA remains under review

Key Figures

Annual NMIBC diagnoses (US): 60,000 people Papillary disease share: 70% Docetaxel OS benchmark: approximately nine months +3 more

6 metrics

Annual NMIBC diagnoses (US) 60,000 people BCG-unresponsive non-muscle invasive bladder cancer population in U.S.

Papillary disease share 70% Proportion of NMIBC patients presenting with papillary (Ta) disease

Docetaxel OS benchmark approximately nine months Median overall survival with docetaxel in PRAGMATICA-LUNG trial control arm

IL-15 ranking year 2007 Year IL-15 was ranked top immunotherapy molecule by major agencies

ANKTIVA FDA approval year 2024 Approval for BCG-unresponsive NMIBC with CIS, with or without papillary tumors

SFDA NSCLC line of therapy second-line and later Setting for ANKTIVA plus checkpoint inhibitors in metastatic NSCLC

Market Reality Check

Price: $8.67 Vol: Volume 22,593,971 is 43% ...

low vol

$8.67 Last Close

Volume Volume 22,593,971 is 43% below the 20-day average of 39,688,362 (relative volume 0.57). low

Technical Price $8.67 is trading above the 200-day MA $3.35 and 30.25% below the 52-week high.

Peers on Argus

IBRX is down 3.24% while closely scored peers like APGE, CELC, and CGON show gai...

2 Up

IBRX is down 3.24% while closely scored peers like APGE, CELC, and CGON show gains of about 3–4%. Momentum peers DNLI and XENE are also up, with XENE rising 16.50%, indicating IBRX’s move is stock-specific rather than sector-driven.

Common Catalyst Peer headlines today include clinical trial data releases, such as XENE’s positive Phase 3 epilepsy study.

Historical Context

5 past events · Latest: Feb 27 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 27	Earnings call preview	Positive	+2.4%	Announcement of upcoming FY 2025 results and business update conference call.
Feb 26	Trial enrollment update	Positive	+0.1%	Completion of QUILT 2.005 enrollment with interim data showing improved CR duration.
Feb 23	Conference participation	Neutral	+17.5%	Founder speaking at Cancer 2035 summit on future oncology roadmap and policy.
Feb 23	Revenue and approvals	Positive	+13.0%	Report of 2025 ANKTIVA revenue growth, global approvals, and strong cash balance.
Feb 20	Commercial partnership	Positive	+1.1%	Partnership to launch ANKTIVA in Saudi Arabia and expand across MENA.

Pattern Detected

Recent news and corporate updates have generally coincided with positive price reactions, suggesting sensitivity to catalysts.

Recent Company History

Over recent weeks, ImmunityBio has reported several notable milestones. On Feb 20–23, 2026, it highlighted Saudi and global launches for ANKTIVA, $113M in 2025 net product revenue with about 700% YoY growth, and extensive international approvals, all followed by gains of up to 12.99%. Additional partnership, revenue, and conference updates also saw positive reactions. Against this backdrop, today’s sBLA resubmission for papillary-only NMIBC fits a pattern of frequent regulatory and clinical progress updates.

Market Pulse Summary

This announcement centers on the FDA’s acknowledgment of ImmunityBio’s resubmitted sBLA for ANKTIVA ...

Analysis

This announcement centers on the FDA’s acknowledgment of ImmunityBio’s resubmitted sBLA for ANKTIVA plus BCG in papillary-only NMIBC, targeting an unmet need among roughly 60,000 U.S. NMIBC patients annually, about 70% of whom present with papillary disease. It also highlights broader momentum, including prior FDA approval in 2024 and SFDA approval in metastatic NSCLC. Investors may focus on upcoming FDA feedback, durability of clinical outcomes, and how these regulatory steps build on recent commercial and pipeline progress.

Key Terms

supplemental biologics license application, carcinoma in situ, il-15, checkpoint inhibitors, +2 more

6 terms

supplemental biologics license application regulatory

"support its supplemental BLA (sBLA) for papillary disease"

A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.

carcinoma in situ medical

"BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors."

Carcinoma in situ is an early-stage abnormal growth where cells look cancerous but remain confined to the tissue surface and have not invaded deeper layers or spread to other parts of the body; think of it like graffiti on a wall that hasn’t cracked the plaster beneath. For investors, it matters because treatments, regulatory pathways, clinical trial outcomes and long-term costs differ greatly between contained lesions and invasive cancer, influencing market value, approval odds and liability for healthcare companies.

il-15 medical

"As far back as 2007, IL-15 was identified by leading scientific and medical organizations"

A naturally produced immune-signaling protein that helps stimulate and sustain certain white blood cells, acting like a text message that tells the body's disease-fighting cells to grow, multiply and stay active. Investors watch IL-15 because therapies that boost or mimic it are being developed to treat cancers and infectious diseases; successful drugs or clinical advances can change a biotech company’s value by opening new treatment markets or improving existing ones.

checkpoint inhibitors medical

"approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer"

Checkpoint inhibitors are drugs that help the immune system recognize and attack cancer cells by blocking certain proteins that normally keep immune responses in check. They act like brakes being released on the immune system, allowing it to target tumors more effectively. These medicines are important for investors because they represent a promising area of cancer treatment with growing research, development, and commercial potential.

non-small cell lung cancer medical

"metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after standard therapies"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

median overall survival medical

"did not demonstrate improved survival compared with docetaxel, reporting a median overall survival of approximately nine months"

Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.

AI-generated analysis. Not financial advice.

• Following multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for papillary disease
• The FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback, the Company resubmitted the sBLA
• The FDA has acknowledged receipt of the resubmitted filing
• 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) disease¹

CULVER CITY, Calif., March 9, 2026 /PRNewswire/ -- ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA^® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) 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 (NMIBC) with papillary tumors have been published in The Journal of Urology.

"As far back as 2007, IL-15 was identified by leading scientific and medical organizations, including the NCI, NIH, FDA, AACR, and ASH, as the number one ranked immunotherapy molecule with the potential to cure cancer," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The mechanism of action of ANKTIVA's IL-15 superagonist activity was affirmed by the FDA's approval of ANKTIVA in 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The long-term data in papillary disease alone demonstrate prolonged disease-free survival and durable bladder preservation, consistent with ANKTIVA's IL-15-based mechanism of action."

Dr. Soon-Shiong added, "We welcome FDA Commissioner Dr. Makary's recent statements in The New England Journal of Medicine highlighting the importance of a "plausible mechanism of action" as an emerging regulatory pathway. The mechanism of action of ANKTIVA, which was recognized in the NCI's 2007 report and reaffirmed in the FDA-approved 2024 package insert, embodies the principles underlying this approach."

Based on the IL-15 mechanism of action and results from the QUILT 3.055 study, the Saudi Food and Drug Authority (SFDA) recently approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer (NSCLC) 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.

About the Papillary Indication: 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 (DFS) 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 (DSS) rate at 36 months, with median DSS not yet reached. Progression-free survival (PFS) 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.

About ANKTIVA^® (nogapendekin alfa inbakicept-pmln)
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.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA^® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA^® with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA^® at Anktiva.com.

References:

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC3357503/#:~:text=Among%20NMIBCs%2C%20around%2070%25%20present,NMIBC%20and%20often%20go%20underutilized.

About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield^™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA^® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release are forward-looking statements, including, without limitation, statements regarding the potential approval of this supplemental biologics license application (sBLA) for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors; the anticipated regulatory review process and timing thereof; the potential clinical benefit, durability of response, and safety associated with ANKTIVA; the potential to address unmet medical needs in patients with papillary-only NMIBC; the potential mechanism of action and therapeutic impact of ANKTIVA; The Company's plans to present additional clinical data; and the Company's plans to pursue regulatory discussions and potential approvals for ANKTIVA in additional indications, including non-small cell lung cancer (NSCLC).

These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management, and are subject to various risks and uncertainties. Actual results may differ materially from those expressed or implied by such forward-looking statements due to a variety of factors, including, but not limited to: the risk that the U.S. Food and Drug Administration (FDA) may determine that the data and information included in the sBLA resubmission are insufficient to support approval; the risk that the FDA may require additional information, analysis, or clinical studies prior to making a determination; the possibility that the FDA may determine that the resubmitted application constitutes a complete response or may issue a complete response letter; uncertainties regarding the timing, outcome, and conduct of the regulatory review process; the possibility that regulatory authorities may not agree with the Company's interpretation of clinical data or assessments of the mechanism of action of ANKTIVA; the possibility that feedback or comments received from the FDA in meetings, written correspondence, or other regulatory interactions may not be predictive of the Agency's ultimate regulatory decision; the risk that information submitted following regulatory meetings may not adequately address FDA questions or concerns; the possibility that additional regulatory interactions may result in new or additional requirements; and uncertainties regarding evolving regulatory standards, policies, or guidance applicable to biologics or oncology therapies; the possibility that clinical trial results may not be replicated in additional studies or real world settings; the potential for delays in regulatory interactions, submissions, or approvals; uncertainties related to the Company's ability to obtain or maintain regulatory approvals in the United States or other jurisdictions; the Company's ability to successfully develop and expand indications for ANKTIVA; competition from other therapies; changes in regulatory requirements standards; and other risks related to the Company's business, operations, and financial condition.

More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

ImmunityBio Contacts:
Investors	Media
Hemanth Ramaprakash, PhD, MBA	Sarah Singleton
ImmunityBio, Inc.	ImmunityBio, Inc.
+1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com	+1 415-290-8045 Sarah.Singleton@ImmunityBio.com

 

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SOURCE ImmunityBio

FAQ

What did ImmunityBio (IBRX) resubmit to the FDA on March 9, 2026?

The company resubmitted a supplemental BLA for ANKTIVA plus BCG in papillary-only NMIBC. According to the company, the filing includes updated long-term follow-up and bladder-preservation efficacy data requested by the FDA.

Did the FDA ask ImmunityBio to run new clinical trials for the IBRX sBLA?

No, the FDA did not request new clinical trials for the resubmission. According to the company, the Agency asked for additional data and updated efficacy results but did not require initiation or redesign of trials.

What clinical evidence did ImmunityBio include in the IBRX sBLA resubmission?

The resubmission included updated long-term follow-up showing durable bladder preservation and safety. According to the company, the data represent extended follow-up and were published in The Journal of Urology.

How does the March 2026 IBRX filing affect patients with papillary-only NMIBC?

The filing aims to expand treatment options for papillary-only NMIBC by seeking approval of ANKTIVA plus BCG. According to the company, the sBLA targets unmet need using long-term efficacy and bladder-preservation data.

Has ANKTIVA received any other recent regulatory approvals relevant to investors in IBRX?

Yes, ANKTIVA gained SFDA approval for combination use in second-line metastatic NSCLC. According to the company, that approval covers ANKTIVA plus checkpoint inhibitors and showed improved median overall survival versus historical chemotherapy.