On February 18, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that management will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, taking place virtually from February 25-26, 2026. Management, including Ben Zeskind, Chief Executive Officer, and Brett Hall, Chief Scientific Officer, will discuss the company’s pipeline, platform, and business strategy.

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Format: Company Presentation and 1×1 Investor Meetings

Date/Time: Thursday, February 26, 2026, at 10:00 am ET

The presentation will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, FEB 18, 2026, View Source [SID1234662751])

On February 18, 2026 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2025, as well as key recent clinical and corporate developments.

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"CEL-SCI is focused on two major value-driving milestones in the near term—starting enrollment in our U.S. FDA confirmatory Registration trial of Multikine in head and neck cancer and advancing Multikine globally in markets including Saudi Arabia. We plan to commence enrollment this summer in our confirmatory study of Multikine in head and neck cancer. Data from this study will be submitted as part of registration applications to allow commercialization and sale of Multikine in the U.S. and other key global markets. Prior studies have shown that pre-surgical tumor responses, such as tumor size reduction and downgrading of the disease by a physician, following Multikine treatment predict substantial survival benefit for the patients. We believe that these pre-surgical tumor responses after the three-week treatment with Multikine, before any other treatment has been administered, could be the basis of an accelerated marketing application for Multikine," stated CEL-SCI CEO, Geert Kersten. "Concurrently, we have been active in Saudi Arabia, pursuing the potential for Multikine to be available to patients with head and neck cancer following the filing for Breakthrough Medicine Designation there in the second half of 2025."

Clinical and Corporate Developments:

CEL-SCI, in conjunction with its CRO Ergomed, expects to start patient enrollment in the summer of 2026 for the 212-patient U.S. Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection)* in newly diagnosed locally advanced head and neck cancer patients. Pre-surgical tumor responses, following a very short treatment with Multikine, can be assessed within weeks after full enrollment for rapid confirmation of Multikine’s anti-tumor activity, creating the potential for early accelerated approval in the U.S. CEL-SCI plans to seek accelerated approval based on early tumor response data. Ergomed is providing comprehensive global clinical operations support to ensure the timely and efficient execution of the trial. CEL-SCI and Ergomed are building on their previous successful collaboration for the global Phase 3 trial of Multikine, the largest study ever conducted in head and neck cancer. In the Phase 3 study, Multikine treatment, given right after diagnosis and before any other treatment, significantly increased the 5-year overall survival rate of the treated patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
CEL-SCI is actively engaged with potential partners and investors in Saudi Arabia to advance Multikine to market. A Breakthrough Medicine Designation application for Multikine for the treatment of head and neck cancer was submitted to the Saudi Food and Drug Authority (SFDA). The designation, if granted, will allow patient access to Multikine for the indication, as well as reimbursement/sale in Saudi Arabia.
Financial Results

During the three months ended December 31, 2025, research and development expenses were $3.7 million compared to $4.4 million for the three months ended December 31, 2024. General and administrative expenses for the three months ended December 31, 2025 were $1.7 million compared to $2.5 million for the three months ended December 31, 2024. Net loss was $5.5 million for three months ended December 31, 2025 compared to $7.1 million in the prior year period. Cash used for operating activities during the quarter was $4.0 million. Basic and diluted net loss per common share was $0.68 for the three months ended December 31, 2025, compared to $3.25 for the three months ended December 31, 2024.

(Press release, Cel-Sci, FEB 18, 2026, View Source [SID1234662767])

On February 18, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.

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ANKTIVA in combination with BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS. With this authorization, ANKTIVA is now approved in 33 countries spanning four regulatory jurisdictions, establishing a global commercial footprint in under two years from initial U.S. Food and Drug Administration (FDA) approval.

The conditional marketing authorization follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, which recommended authorization based on its determination that the benefit of making ANKTIVA available to patients—with a complete response rate of 71%, a median duration of complete response of 26.6 months, and individual responses ranging up to 54+ months and ongoing outweighs the risks associated with earlier access from a single-arm trial. The authorization covers all 27 EU member states Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden as well as Iceland, Liechtenstein, and Norway. ANKTIVA plus BCG is the first immunotherapy to receive marketing authorization in Europe for this NMIBC indication.

As part of the conditional authorization, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy data to the EMA.

"The European Commission’s authorization of ANKTIVA in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "With ANKTIVA now authorized in 33 countries from the United States and United Kingdom to the European Union and Saudi Arabia, we have built the broadest global access platform for an immunotherapy in this indication. With more than 80% of treated patients preserving their bladder through three years of follow-up, ANKTIVA represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG."

Global Regulatory Footprint

ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS is now authorized across four regulatory jurisdictions encompassing 33 countries:

United States: FDA approval, April 2024 (NMIBC CIS with or without papillary tumors)
United Kingdom: MHRA approval, July 2025 (NMIBC CIS with or without papillary tumors)
Kingdom of Saudi Arabia: SFDA accelerated approval, January 2026 (NMIBC CIS with or without papillary tumors; metastatic non-small cell lung cancer)
European Union (30 countries): European Commission conditional marketing authorization, February 2026 (NMIBC CIS with or without papillary tumors). Covers all 27 EU member states plus Iceland, Liechtenstein, and Norway.
The Kingdom of Saudi Arabia remains the only jurisdiction where ANKTIVA has received authorization in two indications, including the first approval globally for ANKTIVA in metastatic non-small cell lung cancer and the first approval for subcutaneous administration.

Unmet Medical Need in Europe

Bladder cancer represents a significant public health burden in the European Union, ranking as the fifth most common cancer overall and the seventh most frequently diagnosed cancer among men.1,2 The European Association of Urology and the World Bladder Cancer Patient Coalition estimate that more than 200,000 new cases of bladder cancer will be diagnosed in 2025.3 Approximately 75% of these cases are NMIBC, the most common form of the disease, which is confined to the bladder lining and has not invaded the underlying muscle layer. For patients whose NMIBC does not respond to BCG therapy, there were no authorized treatment options in the European Union prior to this authorization. The primary alternative has been radical cystectomy, which carries significant morbidity, affects quality of life, and is not suitable for all patients.

Notably, unlike the United States, where only one BCG strain is approved, Europe recognizes and has approved approximately six major BCG strains, making standard-of-care BCG therapy broadly available across the region and supporting a reliable supply for the ANKTIVA plus BCG combination regimen.4

"Reaching 33 countries in under two years from our first regulatory approval is a testament to the strength of the clinical evidence and the urgency of the unmet need in BCG-unresponsive bladder cancer," said Richard Adcock, President and CEO of ImmunityBio. "We are now focused on working with EU member states to ensure timely pricing, reimbursement, and patient access across Europe. Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the U.S. and help ensure that all eligible patients can benefit from this treatment."

Clinical Evidence Supporting Authorization

The conditional marketing authorization was based on results from the QUILT-3.032 study (NCT03022825), a single-arm, open-label, multicenter phase 2/3 clinical trial in 100 adults with BCG-unresponsive NMIBC CIS with or without papillary tumors who received ANKTIVA in combination with BCG administered intravesically.5, 6

Key Efficacy Findings:

Complete response (CR) rate: 71% (95% CI: 61%, 80%), with responses ranging up to 54+ months and ongoing
Median duration of complete response: 26.6 months (95% CI: 13.0, 49.9 months)
Complete response rate among responders at 12 months: 66%; at 24 months: 42%
Cystectomy-free survival among responders: 96% at 12 months, 90% at 24 months, and 84% at 36 months
Disease-specific survival for all patients: 99% at 24 months and 99% at 36 months
Key Safety Findings (Cohorts A and B combined, n=180):

Most treatment-related adverse events were grade 1 to 2
Grade 3 treatment-related adverse events occurred in 3% of patients; no grade 4 or 5 treatment-related adverse events were reported
Most common adverse reactions: dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain, and pyrexia
About ANKTIVA (nogapendekin alfa inbakicept)

ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist (ATC code: L03AC03) consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. In the European Union, ANKTIVA is available as a 400 µg concentrate for intravesical suspension. ANKTIVA binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, ANKTIVA addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced antitumor activity compared to native IL-15 in vivo.

About Conditional Marketing Authorization

A conditional marketing authorization is an EU regulatory mechanism designed to facilitate early access to medicines that address an unmet medical need. This pathway allows the European Commission to grant marketing authorization when the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that additional data are still required. The European Commission’s implementing decision for ANKTIVA (EU marketing authorization number: EU/1/25/2002/001; EMA product number: EMEA/H/C/006622/0000), referenced as C(2026)1197 and dated Brussels, February 16, 2026, was issued by the Director-General for Health and Food Safety under Regulation (EC) No. 726/2004 of the European Parliament and of the Council. As a condition of the authorization, ImmunityBio is required to submit long-term follow-up results from ongoing studies to confirm the efficacy and safety of ANKTIVA. The conditional marketing authorization is subject to annual renewal.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

WARNINGS AND PRECAUTIONS: The possibility of severe systemic BCG-infections with the necessity of anti-tuberculosis therapy should be considered before initiating the BCG-therapy.

Delaying cystectomy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, treated with ANKTIVA therapy in combination with BCG could lead to development of muscle invasive or metastatic bladder cancer.

If patients with CIS that are medically eligible for cystectomy have not achieved a CR (absence of disease or low-grade Ta) to treatment after an induction course of ANKTIVA in combination with BCG at the 12-weeks assessment, cystectomy should be reconsidered as an alternative to re-induction. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.

DOSAGE AND ADMINISTRATION: For intravesical use only. ANKTIVA should NOT be administered by subcutaneous or intravenous or intramuscular use.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

ANKTIVA is administered intravesically as a mixture with BCG.

USE IN SPECIFIC POPULATIONS: Pregnancy: Treatment is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

Please see the Summary of Product Characteristics for ANKTIVA available on the European Medicines Agency website at www.ema.europa.eu.

(Press release, ImmunityBio, FEB 18, 2026, View Source [SID1234662752])

On February 18, 2026 Flatiron Health, a leading healthtech company dedicated to improving cancer care and advancing research using real-world data, reported their first Panoramic datasets in the UK and Germany for patients with prostate cancer. Globally, prostate cancer affects nearly 1.5 million patients annually and has a rapidly evolving treatment landscape, yet real-world evidence remains limited and infeasible to study across international borders.

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Flatiron is the first and only company to deliver global real-world data in this key oncology indication, leveraging proprietary AI and large language model capabilities to build on their Global Evidence Platform. The prostate cancer Panoramic datasets, which encompass the records of nearly 400,000 patients, unlock high-quality, source-level unstructured and structured EHR data across Germany, the UK, and the US. Built on a common data model across all regions, these datasets enable unprecedented interoperability—allowing researchers to seamlessly analyze patient outcomes and treatment patterns across markets to inform global evidence strategies.

"Flatiron is not just adding more data; we are building the singular destination for global oncology intelligence." said Kate Estep, Chief Product Officer at Flatiron Health. "By unifying fragmented global records into a single evidence platform, we are fundamentally changing how our customers develop therapies and—most importantly—when patients can access them."

This launch delivers immediate value to Flatiron’s life science customers. The prostate Panoramic dataset builds on already available offerings to create a full scope of understanding for genitourinary cancers, specifically:

The rich data provides all Prostate-Specific Membrane Antigen (PSMA) PET scan data, all prostate-specific antigen (PSA) values across the patient journey, and 19 Homologous Recombination Repair (HRR) genes, plus recurrence and progression details, enabling answers to key questions like how novel therapies are being used and which patients are benefiting most.
Proprietary AI and large language model capabilities that unlock the full scale of the company’s network, with continuous recency to reflect the evolving treatment landscape and capture newly approved treatments as they enter the market.
Unique patient-level EHR data captured through established site partnerships across Germany, the UK, and the US enable multiregional insights spanning early to late-stage disease and variations across markets.
All Flatiron datasets are validated against the company’s rigorous quality standards, reflect real-world clinical practice, and built by expert teams local to each geography, equipping researchers with the depth needed to answer oncology’s most pressing questions. Combined with the company’s bladder Panoramic dataset—now spanning the full disease spectrum from early-stage through advanced and metastatic disease—these offerings are a clear answer to persistent evidence gaps across genitourinary cancers.

"The field of prostate cancer is evolving at a rapid pace, changing how care is sequenced from early-stage disease through metastatic CRPC and improving outcomes for patients. Yet critical evidence gaps remain, as we see significant regional variation in how novel therapies are used, and in how uneven access to advanced diagnostics differentially influences treatment decisions," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "From a clinical perspective, Flatiron’s global Panoramic datasets directly address these evidence gaps, enabling life science companies to increase confidence in decision-making earlier and accelerate development timelines across diseases and geographies, thereby bringing the next generation of precision medicine to all patients sooner."

This launch marks the first in a series of global dataset expansions, with longitudinal breast cancer and non-small cell lung cancer (NSCLC) datasets planned for 2027. These expansions reinforce Flatiron Health as the gold standard in oncology data, intelligence, and technology. For over a decade, Flatiron has powered the highest-stakes decisions in cancer care and drug development with insights the industry did not have before—shaping what regulators, researchers, clinicians, and biopharma expect from oncology evidence and continuing to redefine that standard. By integrating rigorous real-world data with AI-driven intelligence, Flatiron is doing more than delivering datasets, it is transforming real-world patient experiences into decision-shaping insights that define the future of global cancer care.

(Press release, Flatiron Health, FEB 18, 2026, View Source [SID1234662768])

On February 18, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), a clinical-stage biotechnology company developing immunotherapies for cancer patients, reported that members of its executive team will participate in a fireside chat and one-on-one investor meetings at the following conference:

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Leerink Partners Global Healthcare Conference 2026
• Dates: March 8–11, 2026
• Location: Miami, Florida, United States

Fireside chat:
• Date: March 9, 2026
• Time: 3:40 PM ET / 20:40 CET
• To enter the live webcast, please click here

The link to access the live webcast of the presentation will be available on the Events page of the Investors section of Innate Pharma’s website. A replay of the presentation will be available following the event.

(Press release, Innate Pharma, FEB 18, 2026, View Source [SID1234662753])