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ImmunityBio (IBRX)

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Earnings summaries and quarterly performance for ImmunityBio.

Research analysts covering ImmunityBio.

Recent press releases and 8-K filings for IBRX.

ImmunityBio Announces Positive 3-Year Survival Data for ANKTIVA in Bladder Cancer
IBRX
Product Launch
New Projects/Investments
  • ImmunityBio's ANKTIVA® with BCG demonstrated 96% disease-specific survival at three years in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC).
  • The QUILT-3.032 study, involving 80 subjects, also reported 83% progression-free survival and 82% cystectomy avoidance at 36 months.
  • The treatment showed a tolerable safety profile, with only 3% grade 3 treatment-related adverse events and no grade 4 or 5 events.
  • These findings are particularly significant as there are currently no approved therapies for this specific patient population, making radical cystectomy the primary alternative.
Dec 16, 2025, 2:00 PM
ImmunityBio Receives Conditional Marketing Authorization Recommendation from EMA
IBRX
Product Launch
New Projects/Investments
  • ImmunityBio, Inc. announced on December 12, 2025, that the European Medicines Agency (EMA) recommended granting a conditional marketing authorization for ANKTIVA® in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.
  • This marks the first immunotherapy for NMIBC with carcinoma in situ to receive a positive recommendation for marketing authorization in Europe.
  • The recommendation is based on a single-arm clinical trial of 100 adult patients, which demonstrated a 71% complete response rate with responses lasting approximately 27 months on average.
  • The EMA's opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization.
Dec 12, 2025, 12:01 PM
ImmunityBio receives conditional EMA recommendation for ANKTIVA
IBRX
Product Launch
New Projects/Investments
  • ImmunityBio has received a conditional marketing authorization recommendation from the European Medicines Agency (EMA) for its drug ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.
  • This marks the first immunotherapy approved by the EMA for this condition, offering an important alternative to bladder removal surgery.
  • Clinical trial results showed signs of cancer disappearance in over 70% of patients treated with ANKTIVA.
  • Following the EMA recommendation, ImmunityBio's stock price rose 4.6% in premarket trading.
  • The recommendation addresses a significant patient population, with more than 150,000 people in Europe diagnosed with NMIBC annually.
Dec 12, 2025, 11:17 AM
ImmunityBio receives conditional marketing authorization recommendation for ANKTIVA in Europe
IBRX
Product Launch
New Projects/Investments
  • ImmunityBio's ANKTIVA® with BCG received a conditional marketing authorization recommendation from the European Medicines Agency (EMA) for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ in Europe.
  • This marks the first immunotherapy for NMIBC with carcinoma in situ to receive such a recommendation in Europe, addressing an unmet medical need for patients whose disease does not respond to BCG.
  • The recommendation is based on a single-arm clinical trial that demonstrated a 71% complete response rate in 100 adults with BCG-unresponsive NMIBC, with responses lasting approximately 27 months on average.
  • The EMA's opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization.
Dec 12, 2025, 11:10 AM
ImmunityBio Reports Strong Q3 Revenue Growth Amid Continued Losses
IBRX
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
  • ImmunityBio reported approximately $32 million in third-quarter revenue, representing a 424.7% year-over-year increase, primarily driven by sales of its cancer drug ANKTIVA.
  • Despite the significant revenue growth, the company posted a net loss of $67 million due to high research and development expenses, although its GAAP EPS of -$0.07 exceeded analyst expectations by $0.04.
  • The company's cash reserves rose to nearly $258 million, enhancing its financial runway for pipeline development.
  • ANKTIVA has achieved strong institutional adoption, being recognized as the preferred drug by a major medication contracting organization covering approximately 80 million lives, and has seen a surge in enrollment for its Expanded Access Program due to an ongoing BCG shortage.
  • Investor caution is evident with a 1-year total shareholder return of -61.8%, despite optimistic analyst sentiment and price targets significantly above current share prices.
Nov 5, 2025, 11:07 AM
ImmunityBio Reports Strong Q3 2025 Revenue Growth and Increased Cash Position
IBRX
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
  • ImmunityBio reported $33.7 million in total revenue and other income for Q3 2025, an increase from $26.4 million in Q2 2025. Product revenue for Q3 2025 was $31.8 million, representing a 434% increase from Q3 2024, with year-to-date sales reaching $74.7 million.
  • ANKTIVA unit sales volume grew 467% year-to-date 2025 compared to fiscal year 2024, reflecting strong demand in NMIBC CIS.
  • The company's cash, cash equivalents, and marketable securities increased to $257.8 million as of September 30, 2025, up from $153.7 million on June 30, 2025.
  • ImmunityBio is initiating a randomized registration trial for second-line Glioblastoma patients and has initiated enrollment in a Phase 3 study for Non-Small Cell Lung Cancer. ANKTIVA was also selected as the preferred drug of choice for NMIBC patients with CIS by a large medication contracting organization.
  • Net loss attributable to ImmunityBio common stockholders was $67.3 million for Q3 2025, compared to $85.7 million in Q3 2024, and $289.5 million for the nine months ended September 30, 2025, compared to $354.4 million in the prior year nine months.
Nov 5, 2025, 3:12 AM
ImmunityBio Reports Strong Q3 2025 Revenue Growth and ANKTIVA Demand
IBRX
Earnings
Revenue Acceleration/Inflection
Product Launch
  • ImmunityBio reported Q3 2025 product revenue of $31.8 million, representing a 434% increase from Q3 2024, with year-to-date sales totaling $74.7 million.
  • The company achieved 467% year-to-date unit sales volume growth for ANKTIVA in 2025 compared to fiscal year 2024.
  • As of September 30, 2025, ImmunityBio's cash, cash equivalents, and marketable securities stood at $257.8 million.
  • The net loss attributable to common stockholders for Q3 2025 was $67.3 million, a reduction from $85.7 million in Q3 2024.
  • ANKTIVA was selected as the preferred drug of choice for NMIBC patients with CIS by a large medication contracting organization covering approximately 80 million lives.
Nov 5, 2025, 2:48 AM
ImmunityBio Announces Initial Glioblastoma Trial Data
IBRX
New Projects/Investments
  • ImmunityBio announced early findings from a pilot study (NCT06061809) for recurrent glioblastoma patients treated with a chemotherapy-free regimen combining ANKTIVA, NK cell therapy, and Optune Gio Tumor Treating Fields.
  • The study demonstrated 100% disease control in 5 out of 5 patients, with 3 patients responding (including 2 in near complete response) and 2 with ongoing stable disease.
  • This is significant given that glioblastoma is a devastating brain cancer with a low five-year survival rate (9% for ages 45-54 and 6% for ages 55-64).
  • Based on these encouraging early results, ImmunityBio plans to initiate a randomized trial targeting second-line GBM patients.
Aug 26, 2025, 12:30 PM
ImmunityBio Reports Positive Clinical Trial Results for CD19 CAR-NK Immunotherapy
IBRX
New Projects/Investments
  • ImmunityBio announced early findings from its QUILT-106 Phase I trial, demonstrating highly promising complete responses in the first two patients treated with late-stage Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma, using its CD19 CAR-NK cell therapy.
  • The study showed that an entirely chemotherapy-free immunotherapy regimen induced encouraging responses in heavily pretreated WM patients.
  • One patient achieved a complete response with CD19 CAR-NK monotherapy, while the second patient achieved a complete response with CD19 CAR-NK in combination with rituximab, with remission maintained and ongoing for six months to date.
  • Both patients tolerated the regimen with no significant toxicities, and all infusions were administered in an outpatient setting.
Aug 13, 2025, 12:30 PM
ImmunityBio Reports Q2 2025 Financial Results and Clinical Progress
IBRX
Earnings
Revenue Acceleration/Inflection
New Projects/Investments
  • ImmunityBio reported Q2 2025 revenue of $26.4 million, representing a 60% increase from Q1 2025, with year-to-date sales reaching approximately $43 million.
  • The company's ANKTIVA product experienced 246% unit sales volume growth in the first half of 2025 compared to the second half of 2024, and ImmunityBio held $153.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025.
  • ImmunityBio is actively engaged in discussions with the FDA regarding the filing status of its supplemental Biologics License Application (BLA) for Papillary NMIBC, following a Refuse-to-File decision, and has applied to the National Comprehensive Cancer Network (NCCN) to expand guidelines to include papillary-only disease.
  • Clinical progress includes the initiation of a randomized clinical trial (ResQ201A) for Non-Small Cell Lung Cancer (NSCLC) in the US, with applications submitted in the EU and UK, and supportive feedback from the FDA for its lymphopenia program.
Jul 25, 2025, 10:00 AM