Earnings summaries and quarterly performance for ImmunityBio.
Executive leadership at ImmunityBio.
Board of directors at ImmunityBio.
Research analysts covering ImmunityBio.
Recent press releases and 8-K filings for IBRX.
ImmunityBio Provides Update on ANKTIVA FDA Meeting
IBRX
Product Launch
Guidance Update
- ImmunityBio had a productive Type B End-of-Phase meeting with the FDA regarding its supplemental Biologics License Application for ANKTIVA for BCG-unresponsive papillary non-muscle invasive bladder cancer, with the agency requesting additional information but not new clinical trials. The company plans to provide the requested data within 30 days.
- Long-term QUILT trial results support ANKTIVA's potential as a bladder-sparing option, showing approximately 96% bladder cancer–specific survival at three years and cystectomy-free/bladder-preservation rates of roughly 92% at one year and 82% at three years. ANKTIVA is already approved in the U.S. for carcinoma in situ and in other jurisdictions.
- Following the regulatory news, ImmunityBio shares rose approximately 16–20% in premarket trading, and Piper Sandler raised its price target to $7.00 from $5.00 with an Overweight rating.
- Despite the positive regulatory news, ImmunityBio faces steep operating and net losses, with an operating margin of approximately -315.84% and a net margin of approximately -422.28%.
5 hours ago
ImmunityBio Advances Regulatory Discussions for ANKTIVA Resubmission
IBRX
Product Launch
New Projects/Investments
- ImmunityBio held discussions with the U.S. FDA regarding a potential resubmission path for its supplemental Biologics License Application (sBLA) for ANKTIVA® in BCG-unresponsive papillary bladder cancer.
- The FDA recommended the submission of additional information, not requiring new clinical trials, which ImmunityBio will provide within the next 30 days.
- Long-term data for ANKTIVA in papillary disease demonstrates approximately 96% bladder cancer-specific survival and greater than 80% bladder preservation at three years.
- ANKTIVA is currently approved in the U.S., U.K., E.U. (conditional), and Saudi Arabia for BCG-unresponsive NMIBC CIS with or without papillary tumors.
15 hours ago
ImmunityBio Updates on ANKTIVA® Plus BCG Program for NMIBC
IBRX
New Projects/Investments
- ImmunityBio's enrollment for the QUILT-2.005 trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC) is over 85% complete, with full enrollment anticipated by Q2 2026.
- The company expects to submit a Biologics License Application (BLA) to the FDA by year-end 2026.
- An FDA-requested interim analysis demonstrated that ANKTIVA® plus BCG significantly prolonged the duration of complete response compared to BCG alone.
- At nine months, 84% of patients receiving ANKTIVA® plus BCG maintained a complete response, versus 52% for patients receiving BCG alone, a statistically significant difference (p=0.0455).
4 days ago
ImmunityBio Announces Durable Complete Response in Waldenstrom Lymphoma Clinical Study
IBRX
New Projects/Investments
- ImmunityBio announced updated efficacy and safety results from its ongoing QUILT-106 clinical study evaluating an off-the-shelf CD19 CAR-NK cell therapy in combination with rituximab for patients with Waldenström Non-Hodgkin lymphoma.
- The study demonstrated durable complete responses of 7 and 15 months in two evaluable patients, which are ongoing after receiving a total of eight doses of the therapy with no further treatment.
- This represents the first chemotherapy-free and lymphodepletion-free immunotherapy regimen to achieve 100% disease control in the initial four subjects, administered entirely in an outpatient setting.
4 days ago
ImmunityBio Reports Strong Preliminary Q4 and Full-Year 2025 Revenue and Key ANKTIVA® Approvals
IBRX
Earnings
Revenue Acceleration/Inflection
Product Launch
- ImmunityBio announced preliminary net product revenue of approximately $113.0 million for the full year ending December 31, 2025, reflecting a ~700% year-over-year increase.
- For the fourth quarter of 2025, preliminary net product revenue reached approximately $38.3 million, a 20% increase quarter-over-quarter and a 431% increase compared to the prior year's fourth quarter.
- The company reported an estimated $242.8 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
- The Saudi FDA approved ANKTIVA® for metastatic non-small cell lung cancer, marking its first global approval for this indication and for subcutaneous administration, alongside approval for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ.
5 days ago
ImmunityBio Reports Strong Preliminary 2025 Revenue and ANKTIVA Approvals
IBRX
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
- ImmunityBio reported preliminary full-year 2025 net product revenue of approximately $113.0 million, representing a ~700% increase year-over-year.
- For the three-month period ending December 31, 2025, preliminary net product revenue was approximately $38.3 million, a 20% quarter-over-quarter increase and a 431% increase over the same period in 2024.
- The company achieved 750% unit sales volume growth for ANKTIVA in 2025 compared to 2024.
- The Saudi FDA (SFDA) granted approval for ANKTIVA in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC) and in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), marking the first global approval for NSCLC and the first approval for subcutaneous administration.
- ImmunityBio concluded the quarter with an estimated $242.8 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
5 days ago
ImmunityBio Receives Saudi FDA Accelerated Approvals for ANKTIVA
IBRX
Product Launch
New Projects/Investments
- ImmunityBio, Inc. (IBRX) announced that the Saudi Food and Drug Authority (SFDA) granted accelerated approval for ANKTIVA for two indications: BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and metastatic non-small cell lung cancer (NSCLC).
- The NMIBC approval adds to existing approvals in the U.S., U.K., and conditional approval in the E.U.. The NSCLC approval is notable as the first worldwide approval for this indication and for subcutaneous administration.
- ImmunityBio plans to open a regional office in Saudi Arabia and partner with Biopharma Cigalah for commercial and distribution in the Middle East and North Africa region.
- The company anticipates full enrollment by Q2 2026 for the randomized QUILT-2.005 trial in BCG-naïve NMIBC patients, with a BLA submission targeted by year-end.
6 days ago
ImmunityBio's ANKTIVA Receives Saudi FDA Approval
IBRX
Product Launch
New Projects/Investments
- The Saudi Food and Drug Authority (SFDA) has granted accelerated approval for ImmunityBio's ANKTIVA® for BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary disease.
- This approval expands ANKTIVA's global market presence, adding to existing approvals in the U.S. and U.K., and conditional approval in the European Union.
- ImmunityBio plans to establish a regional office in Saudi Arabia and will collaborate with Biopharma Cigalah as its commercial and distribution partner in the Middle East and North Africa.
- Enrollment in the randomized QUILT-2.005 trial for ANKTIVA in BCG-naïve NMIBC patients is ahead of schedule, with full enrollment anticipated by Q2 2026 and a Biologics License Application (BLA) submission targeted by year-end.
6 days ago
ImmunityBio's ANKTIVA Receives Saudi FDA Accelerated Approval for NSCLC
IBRX
Product Launch
New Projects/Investments
- ImmunityBio's ANKTIVA, in combination with immune checkpoint inhibitors, has received accelerated approval from the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard-of-care therapy.
- This approval is the first worldwide for ANKTIVA in this indication and the first for subcutaneous administration.
- The therapy is highlighted as the first approved chemotherapy-free immunotherapy that activates both natural killer cells and killer T cells.
- ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia and will partner with Biopharma Cigalah for commercial and distribution across the Middle East and North Africa.
6 days ago
ImmunityBio Announces Positive Clinical Trial Results for ANKTIVA in NSCLC
IBRX
New Projects/Investments
- ImmunityBio announced positive results from its ANKTIVA clinical program in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration and improved survival across 151 patients.
- In first-line NSCLC, a randomized study showed a statistically significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA plus checkpoint inhibitor therapy compared to checkpoint inhibitor alone.
- In second- and later-line NSCLC, patients receiving ANKTIVA plus checkpoint inhibitors who achieved immune restoration experienced significantly longer overall survival (median OS 16.2 months vs 11.8 months for non-responders).
- Patients achieving higher immune competence demonstrated a median overall survival of 21.1 months, which exceeds the historical 7-9 months for standard chemotherapy.
- A randomized Phase 3 confirmatory trial (ResQ201A) comparing ANKTIVA plus checkpoint inhibitors versus docetaxel in second-line NSCLC is currently ongoing.
7 days ago
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