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  • RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer

    RARITAN, N.J., February 18, 2026 – Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head and neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus (HPV)-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. RYBREVANT FASPRO™ is approved in multiple settings for the treatment of locally advanced or metastatic non-small cell lung cancer and is also being evaluated in additional solid tumors, including colorectal cancer.

    HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma is characterized by high rates of epidermal growth factor receptor (EGFR) expression and mesenchymal-epithelial transition (MET) pathway overexpression.1,2,3 Subcutaneous amivantamab is designed to target both pathways, while activating the immune system. The clinical activity observed to date supports further evaluation in this setting, where treatment options remain limited after prior lines of therapy.4

    “Patients with HPV-unrelated recurrent or metastatic head and neck cancer often face rapid disease progression and have limited treatment options,” said Kiran Patel, Vice President, Global Head, Solid Tumor Clinical Development and Diagnostics, Johnson & Johnson. “Receiving Breakthrough Therapy Designation underscores the FDA’s recognition of these early clinical data and the urgent need for new therapies. Dual targeting EGFR and MET has shown meaningful clinical benefit in lung cancer, helping patients live longer by changing disease biology and preventing treatment resistance. We are now applying this same multi-targeted approach in head and neck cancer with the goal of improving outcomes for patients.”

    The BTD is supported by data from the open‑label Phase 1b/2 OrigAMI‑4 study. Results were presented in a mini-oral session at the 2025 European Society for Medical Oncology (ESMO) Congress and demonstrate promising clinical activity, with rapid and durable responses, in a heavily pretreated patient population.5 Based on these findings, subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study (NCT07276399), which is assessing the subcutaneous formulation of amivantamab in combination with pembrolizumab and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) as a first-line treatment in patients with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma, regardless of PD-L1 expression.6

    The FDA grants BTD to expedite the development and regulatory review of investigational medicines intended to treat serious or life-threatening conditions, where preliminary clinical evidence indicates the therapy may demonstrate substantial improvement over available treatment options on at least one clinically meaningful endpoint.7

    About the OrigAMI-4 Study
    OrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO™ in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes five cohorts, including Cohort 1, which studied RYBREVANT FASPRO™ as monotherapy in patients with human papillomavirus (HPV)-unrelated R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with prior anti-EGFR therapy were excluded. RYBREVANT FASPRO™ was administered every three weeks (Q3W) at 2400 mg, or 3360 mg for patients weighing 80 kg or more. The primary endpoint is overall response rate (ORR) assessed by blinded independent central review (BICR) using RECIST v1.1**.8

    About Head and Neck Squamous Cell Carcinoma
    Head and neck squamous cell carcinoma (HNSCC) is the most common type of head and neck cancer, accounting for more than 90 percent of cases and approximately 4.5 percent of all cancers worldwide.9 It develops in the mucosal linings of the oral cavity, oropharynx, hypopharynx, and larynx.9 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).9 Around 75 percent of cases are HPV-negative, which is typically associated with a poorer prognosis and reduced response to treatment.9,10 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease.1,4

    About RYBREVANT FASPRO™ and RYBREVANT®
    In December 2025, the U.S. FDA approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) across all indications of intravenous RYBREVANT® (amivantamab-vmjw). This subcutaneously administered therapy is also approved in Europe, Japan, China, and other markets.

    RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.

    The effectiveness of RYBREVANT FASPRO™ has been established based on adequate and well-controlled studies of RYBREVANT®. Data across multiple Phase 3 studies, including MARIPOSA, have demonstrated the clinical benefit of RYBREVANT® in improving progression-free survival (PFS) and overall survival (OS) in advanced EGFR-mutated non-small cell lung cancer (NSCLC).

    RYBREVANT® is approved in the U.S., Europe and other markets across four indications in EGFR-mutated NSCLC, including two in the first-line setting and two in the second line, for patients with either exon 19 deletions, exon 21 L858R mutations, or exon 20 insertion mutations, as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy.

    RYBREVANT® is a first-in-class, fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity.

    The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)§11 include amivantamab-vmjw (RYBREVANT®) across multiple treatment settings, including its recent inclusion as a NCCN Category 1 preferred option when used with lazertinib (LAZCLUZE®) for first-line treatment of people with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Amivantamab and hyaluronidase-lpuj subcutaneous injection (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®). See the latest NCCN Guidelines® for NSCLC for complete information.†‡

    The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-vmjw (RYBREVANT®)-based regimens, including the combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.†‡

    The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc. For more information, visit: https://www.RYBREVANT.com.

    INDICATIONS

    RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT® (amivantamab-vmjw) are indicated:

    • in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
    • in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
    • in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
    • as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.

    IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO™ AND RYBREVANT® 12,13,14

    CONTRAINDICATIONS

    RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

    WARNINGS AND PRECAUTIONS

    Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™

    RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARRs); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3 (n=206), all Grade ARRs occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARRs, 89% occurred with the initial dose (Week 1, Day 1).

    Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.

    Infusion-Related Reactions with RYBREVANT®

    RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients.

    RYBREVANT® as a Single Agent

    In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients.

    Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®.

    Interstitial Lung Disease/Pneumonitis

    RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis.

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis.

    RYBREVANT® as a Single Agent

    In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis.

    Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

    Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE®

    RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA, VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777).

    Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.
    Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification.

    Dermatologic Adverse Reactions

    RYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed.

    RYBREVANT® as a Single Agent

    In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

    When initiating treatment with RYBREVANT FASPRO™ or RYBREVANT®, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

    If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severity.

    Ocular Toxicity

    RYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT® and continue LAZCLUZE® based on severity.

    RYBREVANT® with Carboplatin and Pemetrexed

    Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

    RYBREVANT® as a Single Agent

    In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.
    Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severity.

    Embryo-Fetal Toxicity

    Based on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®.

    ADVERSE REACTIONS

    RYBREVANT FASPRO™ with LAZCLUZE®

    In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).

    Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

    RYBREVANT® with LAZCLUZE®

    In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

    Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

    RYBREVANT® with Carboplatin and Pemetrexed

    In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

    In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

    In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

    In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

    RYBREVANT® as a Single Agent

    In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

    Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

    LAZCLUZE® DRUG INTERACTIONS

    Avoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

    Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

    Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®.

    cp-491009v1

    About Johnson & Johnson
    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.

    Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

    Footnotes:
    **RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.
    §The NCCN Content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
    †See the NCCN Guidelines for detailed recommendations, including other treatment options.
    ‡The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.

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    9 Barsouk A, et al. Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Medical Sciences. 2023;11(2):42. https://doi.org/10.3390/medsci11020042

    10 Ghiani L, Chiocca S. High Risk-Human Papillomavirus in HNSCC: Present and Future Challenges for Epigenetic Therapies. International Journal of Molecular Sciences. 2022;23(7):3483. https://doi.org/10.3390/ijms23073483

    11 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed February 2026.

    12 RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

    13 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

    14 LAZCLUZE® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.


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  • VIAVI Highlights Importance of Trusted Partner Collaboration in AI Era and Outlines Core Solution Areas for Communications and Networking at MWC Barcelona

    VIAVI Highlights Importance of Trusted Partner Collaboration in AI Era and Outlines Core Solution Areas for Communications and Networking at MWC Barcelona

    Over 30 demonstrations across AI data center, security and quantum safe, mission-critical communications, AIOps, 6G and AI-RAN to be showcased at stand 5B18

    CHANDLER, Ariz., Feb. 18, 2026 /PRNewswire/ — VIAVI Solutions Inc. (VIAVI) (NASDAQ: VIAV) has announced its demonstration lineup for Mobile World Congress (MWC) Barcelona 2026, which takes place March 2-5. At VIAVI’s booth 5B18, VIAVI will showcase its latest network testing, automation and intelligence solutions, with technology demonstrations across security and quantum-safe communications, mission-critical communications, AIOps, the AI data center, and 6G / AI-RAN.

    “Networks, AI, security, wireless, photonics and sensing have all previously been separate domains, but they are now converging into a single, tightly coupled system,” said Sameh Yamany, Chief Technology Officer, VIAVI. “This convergence is redefining how networks and critical infrastructure must be designed, validated and protected in these AI-first environments. At MWC, we reflect this new reality. Testing is shifting from components to validating and optimizing behavior, trust and resilience at scale.”

    VIAVI will also host a live digital twin use case demonstration from the stand each day at 4 PM CET, which will highlight how all solution areas featured at the booth integrate into a complete end-to-end digital twin.

    More than 30 demonstrations across five core solution areas will be featured at the VIAVI booth. These include deep dives into the digital twin technologies required to train AI-RAN algorithms for 6G, AI data center scale up / scale out validation, assured Position, Navigation and Timing (APNT), Non-Terrestrial Network (NTN) testing and performance verification, and optimization for PQC/QKD. VIAVI’s new ePRTC360+™, the only non-Cesium holdover clock to maintain 100 ns accuracy in GNSS-denied environments, will also be on display.

    As technology domains converge, partnerships become even more critical. In collaboration with more than 20 partner organizations, VIAVI will highlight additional demonstrations, including Agentic AI-RAN digital twins, ray-tracing-based lab testing of real-world UE behavior and ISAC applications for disaster monitoring. These collaborators include the AI-RAN Alliance, Amphenol, AWS, Calnex, Ericsson, GlobalLogic, Infosys, ITRI, Nokia, NVIDIA, R Systems, Rohde & Schwarz and more.

    About VIAVI
    VIAVI (NASDAQ: VIAV) is a global leader in test and measurement and optical technologies. Our test, monitoring, assurance, and resilient position, navigation and timing solutions enable and secure critical infrastructure ranging from data center ecosystems and communication networks to military, aerospace, railway and first responder communications. In addition, we develop and advance technologies used in high-volume optical applications across anti-counterfeiting, consumer electronics, aerospace, industrial and automotive end markets.

    Learn more about VIAVI at www.viavisolutions.com. Follow us on VIAVI Perspectives, LinkedIn and YouTube.

    Media Inquiries:
    Grand Bridges
    Emma Jenkins
    [email protected]
    +1 415 800 4529

    SOURCE VIAVI Solutions

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  • Machine learning to reveal more about LHC particle collisions

    The CMS Collaboration demonstrates that machine learning can outperform traditional methods in the full reconstruction of particle collisions at the LHC

    The CMS Collaboration has shown, for the first time, that machine learning can be used to fully reconstruct particle collisions at the LHC. This new approach can reconstruct collisions more quickly and precisely than traditional methods, helping physicists better understand LHC data.

    Each proton–proton collision at the LHC sprays out a complex pattern of particles that must be carefully reconstructed to allow physicists to study what really happened. For more than a decade, CMS has used a particle-flow (PF) algorithm, which combines information from the experiment’s different detectors, to identify each particle produced in a collision. Although this method works remarkably well, it relies on a long chain of hand-crafted rules designed by physicists.

    The new CMS machine-learning-based particle-flow (MLPF) algorithm approaches the task fundamentally differently, replacing much of the rigid hand-crafted logic with a single model trained directly on simulated collisions. Instead of being told how to reconstruct particles, the algorithm learns how particles look in the detectors, like how humans learn to recognise faces without memorising explicit rules.

    When benchmarked using data mimicking that from the current LHC run, the performance of the new machine-learning algorithm matched that of the traditional algorithm and, in some cases, even exceeded it. For example, when tested on simulated events in which top quarks were created, the algorithm improved the precision with which sprays of particles – known as jets – were reconstructed by 10–20% in key particle momentum ranges.

    The new algorithm also allows a collision to be fully reconstructed far more quickly than before, because it can run efficiently on modern electronic chips known as graphics processing units (GPUs). Traditional algorithms typically need to run on central processing units (CPUs), which are often slower than GPUs for such tasks.

    “New uses of machine learning could make data reconstruction more accurate and directly benefit CMS measurements, from precision tests of the Standard Model to searches for new particles,” says Joosep Pata, lead developer of the new MLPF algorithm. “Ultimately, our goal is to get the most information out of the experimental data as efficiently as possible.”

    While the new algorithm was tested under current LHC data conditions, it is predicted to be even more useful for data from the High-Luminosity LHC. Due to start running in 2030, the LHC upgrade will deliver approximately five times more particle collisions, posing a significant challenge to the LHC experiments. By teaching detectors to learn directly from data, physicists are not just improving performance, they are redefining what is possible in experimental particle physics.

    Find out more about the algorithm on the CMS website and more about machine learning in particle physics through this CERN colloquium.

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  • Global NCAP strongly criticises misleading media statements issued by Chery — Global NCAP

    Global NCAP strongly criticises misleading media statements issued by Chery — Global NCAP

     The crash test report noted:

    • The footwell area and bodyshell were found to be unstable and not capable of withstanding further loadings.

    • Side pole impact was not performed as the car does not offer standard side head protection for front and rear rows. The lack of this kind of protection exposes the head to the risk of severe injury even in a low speed side impact with a pole or tree.

    • Electronic Stability Control (ESC) was standard, as were Seat Belt Reminders (SBRs) in all positions, although these did not meet Global NCAP requirements.

    Global NCAP strongly criticises Chery for the recent publication of media statements using NCAP results not relevant to the models available in South Africa. NCAP assessments are market specific. Results should not be used selectively to give consumers a false impression of safety performance. 

     Richard Woods, Chief Executive Officer of Global NCAP, said: 

    “A two star rating for the Tiggo 7 Pro is very disappointing, but this poor result  is seriously compounded by the publication of  misleading information on crash test results from other markets. South African consumers need independent and accurate information to inform their purchasing decisions. Transparency and accountability on vehicle safety, not marketing smoke and mirrors.” 

    Bobby Ramagwede, Chief Executive Officer of the Automobile Association of South Africa, said:

    “We note with concern the recent crash test conducted by Chery SA locally, which we deem as both an unsafe exercise and one misleading based on the principles of the NCAP studies undertaken in this critical area of safety. We further note recent media releases around the Tiggo 7 CSH and its five star Euro NCAP rating, and again find this information one-sided as it does not flag the safety inadequacies of the entry-level models in this very range. Euro NCAP ratings are also specific to that market, for a rating to be recognised locally the vehicle needs to be assessed under the #SaferCarsForAfrica campaign conducted by Global NCAP.

    “We have been asked repeatedly by the local consumer to start testing Chinese vehicle brands for local NCAP safety ratings. These latest results highlight two key areas, a continuing pattern in which vehicles sold in Africa do not offer the same safety performance as in other regions, alongside a heightened campaign to avoid disclosing to the local consumer the broader safety picture across a specific vehicle range.

    “We’ve said it before and we’ll say it again, South African motorists deserve better, irrespective of source or price point of a vehicle, with this two star rating reinforcing the urgent need for all manufacturers to commit to equal safety for all markets. This result underlines why Africa urgently needs stronger regulatory standards, combined with an independent consumer information programme and greater manufacturer accountability. The AA believes no vehicle should be sold here without side head protection for front and rear rows. Safety should never be an optional extra, and certainly not reserved for markets outside Africa.”

     

     The Chery Tiggo 7 Pro was tested as part of the #SaferCarsForAfrica campaign.

     

    Chery Tiggo 7 Pro

    Read the full crash test report
    Watch the crash test video
    Download the crash test images

     

    Note to editors

    Global NCAP is a UK registered charity working internationally to democratise vehicle safety in support of the UN Global Goals.

    Between 2014 and 2026 Global NCAP has completed more than 100 safety assessments which have acted as an important catalyst in the safety improvement of Indian and African cars.

    Global NCAP has launched a newsletter, IMPACT, to share information about developments across the global road safety community. Subscribe here: https://www.globalncap.org/impact.

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  • UK inflation rate falls to 3% helped by cost of petrol and bread – follow live

    UK inflation rate falls to 3% helped by cost of petrol and bread – follow live

    Airfares, bread, cereal – what’s behind this fall in the inflation rate?

    Mitchell Labiak
    Business reporter

    Meat, motor fuels, and airfares were picked out by the ONS as some of the things that helped the inflation fate fall.

    Drivers at the pump may have noticed the average price of petrol fell by 3.1p per litre between December 2025 and January 2026, compared with a rise of 0.8p per litre the year before.

    Meanwhile, the pattern of airfares rising in December and then falling in January was “less pronounced than in previous years”, the ONS says.

    A change in food prices also helped to push inflation down. Over the month of January, food prices fell – helping to lower the rate of price rises for the year to January. Meat as well as bread and cereals were two of the biggest drivers of this.

    Bread in a supermarketGetty Images

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  • Valeo Accelerates Industrial Footprint and Technologies in India as Part of its Elevate 2028 Strategic Plan

    Valeo Accelerates Industrial Footprint and Technologies in India as Part of its Elevate 2028 Strategic Plan

    18 February 2026 – New Delhi, India – On the occasion of the AI Impact Summit in New Delhi, taking place from February 16 to 20, 2026, Valeo reaffirms its ambition in the world’s rapidly growing automotive market. Anchored in its new “Elevate 2028” strategic plan, Valeo is announcing its plan to invest more than €200 million in the coming years (approx. ₹2,149.20 Cr, subject to prevailing exchange rates), to significantly expand its industrial footprint in India. These investments will enable Valeo as a first step to triple its sales in India to around €700 million by 2028, and second to prepare for the next step of high growth beyond 2028. The Group is leveraging the rapid acceleration of electrification and AI technologies to serve the growing needs of both Indian and global OEMs.

    “India is a key pillar of Valeo’s global growth and innovation roadmap, and we are committed to significantly expanding our engineering centers and industrial footprint,” said Christophe Périllat, CEO of Valeo. “The pace of transformation in the Indian automotive sector is remarkable, driven by a strong focus on electrification, autonomous driving, and sustainable mobility. As India and France deepen their strategic partnership, Valeo continues investments in localization, R&D, and advanced manufacturing to support India’s ambition to become a global hub for next-generation automotive technologies.”

    Jayakumar G, Group President & Managing Director, Valeo India, said: “India continues to be a strategic market for Valeo, both in terms of manufacturing and advanced engineering. Our focus on localisation—including the e-axle, combo unit (integrated Onboard charger, DCDC converter PDU) for electrified vehicles—along with our work in ADAS, enables us to support customer programs while contributing to the growth of India’s xEV ecosystem.”

    Valeo’s Key Focus Areas in India

    Valeo’s Electrification Strategy in India

    Valeo’s strategy is focused on building strong competencies in new-technology products in India while progressively increasing localisation across manufacturing and operations. The Group is addressing the unique needs of both the passenger vehicle and small mobility (two- and three-wheelers) markets.

    Valeo has commissioned a new plant and dedicated e-axle production lines at its Pune facility to support a major electrification program with Mahindra & Mahindra (M&M), India’s leading SUV manufacturer. Valeo has been selected to supply electric powertrains for a range of vehicles under M&M’s ‘Born Electric’ passenger vehicle platform, along with on-board charger combo units for its electric utility vehicles. This strategic partnership represents a total order value close to 1 billion USD and reinforces Valeo’s commitment to localisation and the growth of India’s electric mobility ecosystem.

    In the two- and three-wheelers segment, India being the world’s largest market in two-wheelers, Valeo has entered a partnership with Atul Greentech Private Limited (AGPL) and Honda Power Pack Energy India Private Limited (HEID) in 2024 for three-wheelers.

    Honda’s advanced battery technology, combined with Valeo’s compact Powertrain unit and Atul Greentech’s expertise in three-wheeled electric vehicles, will provide a reliable and sustainable solution for urban transport. This initiative is expected to accelerate the adoption of EVs in India, contribute to emission reduction and promote cleaner and greener mobility solutions in the region.

    Valeo is introducing a new generation small mobility generator which is rare-earth-free magnet motors for the greater two-wheeler electrification market.

    Safety: ADAS and ARAS Solutions

    • ADAS in Passenger and Commercial Vehicles

    Valeo is expanding its Advanced Driver Assistance Systems (ADAS) capabilities to foster safer mobility globally. As AI-driven engineering, simulation, and validation play an increasingly important role in the development of electrification and ADAS technologies, Valeo’s Chennai R&D centre contributes significantly to software development, AI-enabled engineering, and system validation for electrification and ADAS programs worldwide. With a strong focus on high-end engineering and digital capabilities, the Chennai team supports Valeo’s objective of delivering safe, sustainable, and affordable mobility solutions at scale.

    Valeo’s Sanand plant in Gujarat is expanding its operations to support the growing demand for ADAS products. The facility currently supplies ultrasonic sensors to major OEMs in India. As part of this expansion, Valeo is implementing new camera production lines, which are scheduled to commence production by mid-2026. This investment strengthens the company’s local ADAS manufacturing footprint and reinforces its ability to deliver advanced, scalable safety solutions aligned with the evolving needs of the Indian automotive market.

    • Two- and Three-Wheelers: Enhanced Rider Protection

    Deploying electrification solutions and Advanced Rider Assistance Systems to accelerate the adoption of sustainable mobility solutions, and enhance safety. At CES 2026, Valeo and Hero MotoCorp, the world’s largest manufacturer of motorcycles and scooters, announced their strategic partnership on Advanced Rider Assistance Systems. By combining Valeo’s radar and smart camera technologies with Hero’s deep understanding of local traffic conditions, these innovations aim to reduce road accidents, enhance the riding experience, and set new global standards for two-wheeler safety. Several proof-of-concept systems have already been successfully developed to protect both riders and pedestrians.

    Technology and AI in R&D

    Valeo is advancing the use of Artificial Intelligence across its research and development activities to improve efficiency, accelerate innovation, reduce costs and lead time across the value chain. Valeo’s R&D centres in India play an important role in global innovation programs for all the Group’s activities. The Valeo Group Technical Center in Chennai, along with its satellite center in Bangalore, serves as a powerhouse for research, development, and innovation, bringing together over 3,300 top engineering talents. Valeo has also expanded its state-of-the-art lab to become self-reliant in its testing and validation capabilities.

    From Automotive to New Applications, Including Data Center Cooling

    Valeo also strengthens its AI and R&D ecosystem through strategic partnerships, including with 2CRSi, to develop innovative, energy-efficient liquid cooling solutions for edge data centers. Established in November 2025, this collaboration focuses on developing an Autonomous Immersion-cooled edge compute solution engineered to withstand harsh outdoor environments. A primary use case for this technology is supporting 5G deployment in India, where Valeo provides the essential casing and thermal management for the servers.

    Valeo in India

    Valeo has operated in India since 1997. The Group runs 6 production sites across Chennai, Pune, Sanand, and Gurgaon and global R&D Centres in Chennai and Bangalore. Valeo employs over 7,500 people in India, with over 50% engineers contributing to global research, development, and manufacturing activities.

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  • Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU)

    Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU)

    • Statistically significant and clinically meaningful results seen in RemIND trial with complete responses achieved in 3 CIndU types1
    • Remibrutinib, a highly selective oral BTK inhibitor, was well-tolerated and demonstrated a favorable safety profile, including no liver safety concerns1
    • Oral remibrutinib has potential to be first targeted therapy approved for CIndU, which affects estimated 29 million adults worldwide2,3

    Basel, February 18, 2026 – Novartis today announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU)1. The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 121. These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need.

    “The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.”

    Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of CIndU. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented in upcoming medical congresses.

    About remibrutinib
    Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives (wheals) and swelling4–6. By reducing histamine release, remibrutinib helps relieve the symptoms of CIndU1,7. In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido®. Remibrutinib is being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio8–11.

    About RemIND trial
    The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of remibrutinib in adults with CIndU inadequately controlled by H1-antihistamines12. The primary endpoint of RemIND is the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes12.

    About Chronic Inducible Urticaria (CIndU)
    CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide2,3. It is a form of chronic urticaria characterized by hives and/or swelling, with identifiable external triggers, like pressure, sunlight, friction, heat, cold or water13. CIndU differs from chronic spontaneous urticaria (CSU), which has no specific triggers14. CIndU places a significant burden on daily life, with many patients cycling through antihistamines without adequate relief15. With no approved targeted therapies available today, there remains a clear and longstanding gap in effective treatment options for these patients15,16.

    The most prevalent CIndU subtypes are symptomatic dermographism, cold urticaria, and cholinergic urticaria17. Symptomatic dermographism manifests with itchy hives caused by shear force on skin, such as friction or light scratching, which appear in less than 5 minutes after contact and usually last 30 minutes13. Cold urticaria occurs after skin exposure to cold, leading to wheals or angioedema that develop within minutes after exposure and are usually limited to exposed areas13. Cholinergic urticaria manifests with characteristic small, punctate hives triggered by active or passive heating of the body, including exercise, strong emotions, or bathing in hot water 13. 

    About Novartis Immunology
    At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.

    Disclaimer
    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

    About Novartis
    Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

    Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

    References

    1. Data on files
    2. Maurer M, et al. How to approach Chronic Inducible Urticaria, The Journal of Allergy and Clinical Immunology, 2018, Volume 6, Issue 4, Pages 1119-1130
    3. World Population Prospects, Department of Economic and Social Affairs Population Division, United Nations. Available from: https://population.un.org/wpp/downloads?folder=Standard%20Projections&group=Population [Last accessed: February 2026]
    4. Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022; 150: 1498-1506. 
    5. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (remibrutinib), a potent and highly selective covalent inhibitor of Bruton’s Tyrosine Kinase. J Med Chem 2020; 63: 5102-5118. 
    6. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565.
    7. Patient. Antihistamines. Last updated 12 October 2022. Available from: https://patient.info/allergies-blood-immune/allergies/antihistamines [Last accessed: February 2026].  
    8. ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from: https://clinicaltrials.gov/ct2/show/NCT03827798. [Last accessed: February 2026]
    9. ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from: https://clinicaltrials.gov/study/NCT05432388 [Last accessed: February 2026].
    10. ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from: https://clinicaltrials.gov/study/NCT05147220 [Last accessed: February 2026].
    11. ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from: https://clinicaltrials.gov/study/NCT05156281 [Last accessed: February 2026].
    12. ClinicalTrials.gov. NCT05976243. A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines. Available from: https://clinicaltrials.gov/study/NCT05976243 [Last accessed: February 2026].
    13. Pozderac I, et al. Chronic inducible urticaria: classification and prominent features of physical and non-physical types. Acta Dermatovenerol Alp Pannonica Adriat. 2020;29(3):141–8
    14. Zuberbier et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis and management of urticaria. Allergy.2022;77(3):734–66
    15. M Kern B, et al. Physician estimation of the prevalence and clinical impact of chronic urticaria: results of the global, multicenter UCARE CU-PAPER study, Frontiers in allergy, 2026, volume 6:1732893
    16. Munoz M, et al. New insights into chronic inducible urticaria. Current Allergy and Asthma Reports, 2024 volume 24, 457-469
    17. Kolkhir P, et al. Urticaria. Nat Rev Dis Primers. 2022;8(61)

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  • Ericsson and Mastercard enhance global digital money movement and accelerate digital financial inclusion

    • Collaboration simplifies access to advanced money movement solutions for telecom service providers, fintechs and banks
    • Strengthens digital ecosystems across emerging and developed markets
    • Increases financial digital inclusion for unbanked and underbanked communities

    STOCKHOLM, Feb. 18, 2026 /PRNewswire/ — Ericsson (NASDAQ: ERIC) and Mastercard today announce a collaboration to reshape how money moves across the world. By integrating the Ericsson Fintech Platform (Mobile Financial Services) with Mastercard Move – Mastercard’s portfolio of money movement solutions – the collaboration will empower telecom service providers, banks, and fintechs to expand digital wallet capabilities, launch new payment services, and reach unbanked or underbanked communities.

    Ericsson’s pre-integrated application programming interfaces (APIs), cloud-native deployment and compliance-ready infrastructure simplifies fintech connectivity to Mastercard Move.

    These capabilities reduce technology complexity, lower operational barriers (by simplifying integration, deployment and compliance) and accelerate time to market for new payment services – all aimed at catalyzing innovation and growth in the sector.

    The Ericsson-Mastercard collaboration transforms how financial services are built, delivered and scaled. It creates new revenue streams and strengthens digital ecosystems across emerging and developed markets.

    Financial inclusion and accessibility are key focuses of the collaboration. Mastercard Move enables money movement across 200 countries and territories, connecting more than 17 billion endpoints, and supporting transactions in 150 currencies.

    Ericsson’s fintech platform operates in 22 countries, serving more than 120 million active users and processing more than four billion transactions every month across digital wallets, payments, remittances, lending, and loyalty services – all backed by enterprise-grade security.

    Mastercard Move’s integration into Ericsson’s Fintech Platform aims to accelerate the adoption of digital payments and expand participation in the digital economy. The global rollout will begin in the Middle East and Africa, where demand for mobile money, remittances and interoperable payment services is particularly strong.

    Pratik Khowala, Global Head of Transfer Solutions, Mastercard, says: “Mastercard Move empowers payment service providers to shape the future of money movement – delivering fast, secure and transparent transfers for individuals and businesses worldwide. By integrating with Ericsson’s fintech platform, we’re opening new pathways for telecom operators, financial institutions and fintechs to scale innovative payment services, reach underserved communities and unlock fresh revenue streams. This collaboration not only meets the rising demand for digital cross-border payments, but also accelerates progress toward a more connected, inclusive and dynamic global digital economy.”

    Pavan Bachwal, Head of Mobile Financial Services, Ericsson, says: “Joining forces with Mastercard marks a bold step toward the future of money movement. Combining Ericsson’s trusted, scalable platform with Mastercard Move enables our customers to launch secure and efficient payment solutions faster than we ever have before. Together, we are driving financial inclusion, accelerating innovation, and creating new growth opportunities across the globe.”

    Related link:

    Ericsson Mobile Financial Services

    NOTES TO EDITORS:

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    Ericsson’s high-performing, programmable networks provide connectivity for billions of people every day. For 150 years, we’ve been pioneers in creating technology for communication. We offer mobile communication and connectivity solutions for service providers and enterprises. Together with our customers and partners, we make the digital world of tomorrow a reality. www.ericsson.com

    ABOUT MASTERCARD:

    Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we’re building a resilient economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential. www.mastercard.com

    Media Contact: Giang Nguyen, Mastercard, [email protected]

    This information was brought to you by Cision http://news.cision.com

    https://news.cision.com/ericsson/r/ericsson-and-mastercard-enhance-global-digital-money-movement-and-accelerate-digital-financial-inclu,c4308787

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  • AIO Trial: Nintedanib Plus Nivolumab in Previously Treated Advanced or Metastatic Lung Cancer

    AIO Trial: Nintedanib Plus Nivolumab in Previously Treated Advanced or Metastatic Lung Cancer

    Patients with previously treated metastatic lung adenocarcinoma face a well-recognized therapeutic limitation once platinum-based chemotherapy and immune checkpoint inhibitors (ICIs) have been exhausted.
    Beyond these standards, available options historically provide:

    • Modest response rates
    • Short disease control
    • Limited survival extension

    As a result, there has been increasing interest in microenvironment-directed combination strategies, particularly those integrating:

    • Immune checkpoint blockade, which restores antitumor T-cell activity
    • Anti-angiogenic therapy, which can reduce VEGF-mediated immune suppression, normalize tumor vasculature, and potentially re-sensitize tumors to immunotherapy

    Within this evolving framework, combining nivolumab with the multitarget anti-angiogenic tyrosine kinase inhibitor nintedanib represents a biologically rational attempt to overcome acquired resistance after prior systemic therapy.

    Metastatic Lung Cancer: Causes, Symptoms, Treatment, and 2025 Advances in Therapy

    Study Design

    This investigation was conducted as a multicenter, open-label, single-arm phase Ib/II trial enrolling patients with advanced (stage IIIB/IV) lung adenocarcinoma who had already received one or two prior systemic treatment lines, including platinum-based chemotherapy with or without previous exposure to immune checkpoint inhibitors.

    A conventional 3+3 dose-escalation strategy was used to determine the recommended phase II dose of the nivolumab–nintedanib combination.
    Beyond dose finding, the study was designed to characterize three core clinical dimensions:

    • Safety and tolerability of the combined immune–antiangiogenic approach
    • Disease control durability, assessed through progression-free survival at 6 and 9 months
    • Biomarker-associated survival patterns, with particular attention to PD-L1 expression and FGFR1 signaling status, both of which may influence responsiveness to therapy

    Together, this framework aimed not only to establish feasibility, but also to explore whether biologic stratification could identify patients most likely to benefit from this combination strategy.

    Recommended Dose and Safety

    The combination proved clinically feasible at:

    • Nintedanib 200 mg twice daily
    • Nivolumab 240 mg every two weeks

    Importantly, no new safety signals were observed, confirming that dual immune-angiogenic targeting can be delivered without unexpected toxicity in pretreated patients.

    AIO Trial

    Opdivo (Nivolumab): Uses in Cancer, Side Effects, Dosages, Expectations, and More

    Clinical Activity

    Disease Control

    At the recommended phase II dose, the nivolumab–nintedanib combination demonstrated measurable but limited disease stabilization in this heavily pretreated population.
    Approximately one quarter of patients remained progression-free at six months, while around 10% maintained progression-free status at nine months, indicating that a subset of tumors achieved meaningful short-term control despite prior treatment exposure.

    Overall Survival

    Median overall survival was approximately 12 months, though outcomes varied markedly according to underlying tumor biology.
    Long-term survival at 36 months reached nearly 70% in tumors with high PD-L1 expression, compared with about 40% in tumors characterized by both low PD-L1 and low FGFR1 expression.
    In contrast, low PD-L1 tumors with high FGFR1 signaling were associated with distinctly poorer survival outcomes.

    Taken together, these findings emphasize that clinical benefit from combined immune checkpoint inhibition and anti-angiogenic therapy is strongly shaped by the interaction between immune activation and angiogenic signaling pathways, rather than by PD-L1 status alone.

    Immune Checkpoint Rechallenge

    A particularly interesting signal emerged in patients previously treated with checkpoint inhibitors.
    These individuals showed longer survival than checkpoint-naïve patients, suggesting that:

    • Resistance to immunotherapy may not be permanent
    • Anti-angiogenic therapy could help restore immune sensitivity

    This concept is becoming increasingly relevant across modern immunotherapy sequencing strategies.

    Biological Interpretation

    Several important biological insights emerge from this study.

    First, immune–angiogenic combinations do not appear to generate uniform benefit across all patients, yet carefully defined biological subgroups may achieve clinically meaningful long-term survival. This reinforces the growing recognition that treatment efficacy in advanced lung cancer is increasingly context-dependent rather than universal.

    Second, the data suggest that FGFR-driven tumor biology may contribute to immune resistance, highlighting FGFR signaling as a potential mechanistic barrier to effective checkpoint inhibition. In this context, FGFR blockade through agents such as nintedanib may function as a rational partner to immunotherapy, particularly in tumors characterized by angiogenic or growth-factor–mediated immune suppression.

    Third, the observation that patients previously exposed to checkpoint inhibitors derived improved outcomes upon rechallenge supports the evolving concept that tumor microenvironmental state—rather than prior treatment exposure alone—determines renewed immunotherapy sensitivity. This aligns with broader evidence that immune resistance can be dynamic and potentially reversible.

    Clinical Meaning

    Taken together, these findings position the combination of nivolumab plus nintedanib as a strategy that is clinically feasible and safe in pretreated lung adenocarcinoma, with modest overall activity but meaningful potential in biomarker-defined subgroups.

    Importantly, the regimen may offer a mechanism-based opportunity to re-sensitize tumors to immunotherapy, particularly in patients with prior checkpoint exposure. Rather than serving as a universal treatment approach, this combination is better understood as a precision-oriented therapeutic option that may benefit carefully selected patients defined by immune and angiogenic biology.

    Key Takeaway Messages

    • The nivolumab–nintedanib combination is feasible and well tolerated in previously treated lung adenocarcinoma.
    • Overall efficacy is limited, but durable survival emerges in biologically defined subgroups.
    • High PD-L1 expression and prior checkpoint exposure appear to predict the greatest benefit.
    • FGFR signaling may represent an important resistance pathway influencing outcomes.
    • Future development should focus on biomarker-driven patient selection and immunotherapy rechallenge strategies rather than broad, unselected use.

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  • Perplexity drops advertising as it warns it will hurt trust in AI

    Perplexity drops advertising as it warns it will hurt trust in AI

    Stay informed with free updates

    AI start-up Perplexity has abandoned advertising over fears that it will erode user trust, despite rivals pushing ahead with introducing ads as they seek strategies to make money from the technology.

    San Francisco-based Perplexity was one of the first generative AI companies to introduce ads in 2024, running tests in which sponsored answers were displayed under the chatbot’s answers.

    However, the company — which also offers paid subscriptions — began phasing out the ads late last year. On Tuesday, executives at the company said it had no plans to pursue advertising further.

    “A user needs to believe this is the best possible answer, to keep using the product and be willing to pay for it,” a Perplexity executive said.

    Perplexity’s ads were labelled and the company said they had no bearing on the chatbot’s responses.

    But the executive said in general “the challenge with ads is that a user would just start doubting everything . . . which is why we don’t see it as a fruitful thing to focus on right now”.

    It comes as leading AI groups have followed Perplexity in introducing advertising to start making money from free users and appease investors as they burn through cash to train and sustain the large language models that underpin popular products.

    OpenAI last week began testing advertising on its core product, ChatGPT, for users who do not pay for a subscription. It has a similar model, where labelled ads appear below answers. It has emphasised that ChatGPT’s answers are not influenced by these sponsors.

    Google has advertising in AI mode, as well as in its AI Overviews summaries on traditional search. But the search giant has so far held off introducing ads into its Gemini chatbot.

    In contrast, Anthropic this month committed to keeping its chatbot Claude free from ads.

    Perplexity was also one of the first to introduce shopping features on its platform, followed by Google and OpenAI. Unlike its competitors, however, executives said Perplexity did not make money from this feature or a cut of sales.

    Valued at $18bn, with a reported $200mn in annualised revenues, Perplexity makes the majority of its money from subscriptions. It offers free services, as well as tiers ranging from $20 to $200 a month. It has more than 100mn users, according to executives.

    Ads on Perplexity have been wound down, and executives said it is primarily focused on ensuring answers are accurate.

    “We are in the accuracy business, and the business is giving the truth, the right answers,” said another Perplexity executive. Although it could revisit advertising in the future, the executive said it was “misaligned with what the users want” and it might “never ever need to do ads”.

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