The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
* Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
* Have a baseline food challenge before starting omalizumab.
* Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
* Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
* Have skin prick testing and blood tests at study visits.

Start Date19 Oct 2026

Sponsor / Collaborator

The Johns Hopkins University

NCT07816328

/ RecruitingPhase 3

A Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks

The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).

Start Date21 Sep 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Australia Pty Ltd.

ChiCTR2600121053

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Omalizumab in Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA): A Multicenter, Randomized, Single‑Blind, Placebo‑Controlled Clinical Study

Start Date01 Apr 2026

Sponsor / Collaborator

The First Affiliated Hospital of Ningbo University

100 Clinical Results associated with Omalizumab

100 Translational Medicine associated with Omalizumab

100 Patents (Medical) associated with Omalizumab

4,093

Literatures (Medical) associated with Omalizumab

01 Jan 2027·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Arginine regulates intermolecular interactions to stabilize lyophilized high-concentration omalizumab: dry-state characterizations and molecular dynamics insights into reconstitution and viscosity

Article

Author: Ouyang, Jun ; Ye, Cheng-Han ; Lv, Jia-Yi ; Hang, Tongyu ; Fang, Wei-Jie ; Sun, Ziqiao ; Li, Hongwen ; Gao, Han

High-concentration monoclonal antibody formulations (HCMFs) are widely adopted in modern biopharmaceuticals owing to their suitability for subcutaneous administration and superior patient compliance. Nevertheless, lyophilized HCMFs face major technical obstacles, including high solution viscosity, prolonged reconstitution duration, and excessive bubble formation, which impair manufacturability and impede clinical translation. While arginine serves as an effective viscosity-lowering excipient for concentrated protein solutions, its low intrinsic glass transition temperature (T_g') leads to lyophilization instability and cake collapse. These drawbacks limit its applicability in freeze-dried products. In this work, a binary excipient system consisting of trehalose and low-dose arginine was developed to overcome the above limitations. The high T_g' of trehalose synergistically offsets the low-T_g'-associated deficiencies of arginine within concentrated protein matrices, thereby maintaining favorable long-term physical and chemical stability of lyophilized omalizumab. Molecular dynamics simulations of reconstituted high-concentration omalizumab solutions further revealed the underlying viscosity-reduction mechanism. Arginine attenuates attractive protein-protein interactions, enlarges the colloidal radius (R_c) of antibody assemblies, promotes water infiltration into colloidal voids, and intensifies molecular Brownian motion, which fundamentally reduces solution viscosity and improves reconstitution performance. Overall, this study clarifies the incompatibility between arginine and lyophilized omalizumab and provides mechanistic guidance for the molecular modulation of viscosity in high-concentration monoclonal antibody formulations.

31 Dec 2026·mAbs

Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies

Article

Author: Andersen, Nisana ; Luu, Steven ; Stephens, Nicole ; Bol, Karenna ; Mehta, Shrenik ; Heisler, Joel ; Swartz, Trevor ; Kovner, Daniel ; Rude, Erina ; Makowski, Emily ; Ibrahim, Julissa ; Zarzar, Jonathan ; Carter, Paul J. ; Stepurska, Kateryna ; Baginski, Tomasz ; Izadi, Saeed ; Paidi, Santosh Kumar ; O’Connor, Kelly

Predicting high-concentration viscosity of monoclonal antibodies is crucial for their development as therapeutics for subcutaneous delivery, but traditional experimental rheometry methods for assessing viscosity are low-throughput, which limits their utility. This study evaluates self-interaction nanoparticle spectroscopy (SINS) assays - specifically charge-stabilized SINS (CS-SINS) and PEG-stabilized SINS (PS-SINS) - for high-throughput viscosity prediction. We characterized 96 IgG₁ antibodies, assessing SINS against in silico descriptors and dynamic light scattering (DLS) data. CS-SINS showed strong correlation with charge, offering limited additional utility. In contrast, PS-SINS provided orthogonal information; integrating it with in silico data and DLS significantly improved random forest model accuracy for binary viscosity classification. PS-SINS measurements in multiple buffers captured complementary information, achieving comparable accuracy without DLS. Importantly, PS-SINS scores exhibited a strong logarithmic relationship with high-concentration viscosity in Fc variants of clinical antibodies (r = 0.72 and r = 0.85 for trastuzumab and omalizumab variants, respectively), suggesting a direct mechanistic link. Furthermore, PS-SINS performed reliably with one column-purified (protein A) samples, supporting its early-stage application. These findings establish PS-SINS as a high-throughput tool to accelerate the developability assessment of antibody candidates.

31 Dec 2026·ANNALS OF MEDICINE

Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma

Article

Author: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio

BACKGROUND:

Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .

OBJECTIVE:

To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.

METHODS:

A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.

RESULTS:

Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.

CONCLUSION:

Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.

377

News (Medical) associated with Omalizumab

27 Oct 2026

·www.biospace.com

Novartis delivered sales growth and core margin expansion in Q3; raised FY core operating income guidance

Ad hoc announcement pursuant to Art. 53 LR Third quarter Q3 net sales grew +4% (cc ¹ , +4% USD), with core operating income ¹ +10% (cc, +11% USD) Sales growth driven by priority brands including Kisqali (+37% cc), Kesimpta (+22% cc), Scemblix (+67% cc), Leqvio (+63% cc) and Cosentyx (+9% cc) Core operating income margin ¹ was 41.6%, +2 percentage points (cc) Q3 operating income declined -61% (cc, -59% USD) mainly due to a partial impairment of the del-desiran asset; net income down -71% (cc, -70% USD) Q3 core EPS ¹ grew +8% (cc, +9% USD) to USD 2.46 Q3 free cash flow ¹ was USD 5.1 billion (-18% USD) 9 months net sales (0% cc, +2% USD) and core operating income (-2% cc, -1% USD) broadly in line with PY Q3 selected innovation milestones: Remibrutinib positive PhIII REMODEL-1 and -2 results in RMS Rhapsido FDA approval in most prevalent form of CIndU Pluvicto FDA and CN approvals in mAPMN/S prostate cancer Pelabresib EU submission completed in MF Del-zota FDA priority review granted for DMD44 Full-year 2026 guidance² raised for core operating income Net sales expected to grow low single-digit (unchanged) Core operating income expected to be in line to grow low single-digit (from decline low single-digit) Basel, October 27, 2026 – Commenting on Q3 2026 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered solid sales growth in Q3, as priority brands and launches more than offset generic erosion, demonstrating the replacement power of the business. Combined with productivity efforts, this drove strong bottom-line performance and allowed us to upgrade our full-year guidance. At the same time, we continued to advance our pipeline, with positive Phase III results for remibrutinib in RMS, label expansions for Rhapsido and Pluvicto in the US, and the first submission for pelabresib in the EU. While the del-desiran readout in DM1 was not what we had hoped, we saw evidence of clinical activity in the data and are working through the development path for this medicine. Importantly, our programs in FSHD and DMD continue to progress well. With continued momentum across the business and pipeline, we remain well on track to deliver our mid- and long-term outlook.” Key figures Q3 2026 Q3 2025 % change 9M 2026 9M 2025 % change USD m 3 USD m 3 USD cc USD m 3 USD m 3 USD cc Net sales 14 522 13 909 4 4 42 043 41 196 2 0 Operating income 1 843 4 501 -59 -61 10 828 14 028 -23 -24 Net income 1 196 3 930 -70 -71 7 609 11 563 -34 -35 EPS (USD) 0.63 2.04 -69 -70 4.01 5.94 -32 -33 Free cash flow 5 111 6 217 -18 14 002 15 941 -12 Core operating income 6 036 5 460 11 10 16 873 16 960 -1 -2 Core net income 4 655 4 330 8 6 13 027 13 522 -4 -5 Core EPS (USD) 2.46 2.25 9 8 6.85 6.94 -1 -3 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 45 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. 3. USD millions unless indicated otherwise. Strategy Our focus Novartis is a “pure-play” innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan. Our priorities Accelerate growth : Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas. Deliver returns : Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility. Strengthen foundations : Unleashing the power of our people, scaling data science and technology, and continuing to build trust with society. Financials Third quarter Net sales were USD 14.5 billion (+4%, +4% cc), with volume growth contributing 14 percentage points, partly offset by 9 percentage points from generic competition. Pricing had a negative impact of 1 percentage point, and currency had no impact. Operating income was USD 1.8 billion (-59%, -61% cc), declining mainly due to higher R&D expenses, including a USD 1.9 billion partial impairment charge of the del-desiran IPR&D asset, and higher other expense, partly offset by higher net sales. Net income was USD 1.2 billion (-70%, -71% cc), declining mainly due to lower operating income and higher interest expense. EPS was USD 0.63 (-69%, -70% cc). Core operating income was USD 6.0 billion (+11%, +10% cc), mainly driven by higher net sales. Core operating income margin was 41.6% of net sales, increasing 2.3 percentage points (2.0 percentage points in cc). Core net income was USD 4.7 billion (+8%, +6% cc), driven by higher core operating income, partly offset by higher interest expense. Core EPS was USD 2.46 (+9%, +8% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 5.1 billion (-18%), declining due to lower net cash flows from operating activities. Nine months Net sales were USD 42.0 billion (+2%, 0% cc), with volume growth contributing 14 percentage points, partly offset by 12 percentage points from generic competition. Pricing had a negative impact of 2 percentage points, and currency had a positive impact of 2 percentage points. Operating income was USD 10.8 billion (-23%, -24% cc), declining mainly due to higher R&D expenses, including a USD 1.9 billion partial impairment charge of the del-desiran IPR&D asset, and higher other expense. Net income was USD 7.6 billion (-34%, -35% cc), mainly due to lower operating income, higher interest expense and higher income taxes. EPS was USD 4.01 (-32%, -33% cc). Core operating income was USD 16.9 billion (-1%, -2% cc), declining mainly due to higher R&D expenses and higher other expense, partly offset by lower SG&A expenses. Core operating income margin was 40.1% of net sales, decreasing 1.1 percentage points (0.8 percentage points in cc). Core net income was USD 13.0 billion (-4%, -5% cc), mainly due to lower core operating income and higher interest expense. Core EPS was USD 6.85 (-1%, -3% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 14.0 billion (-12%), declining due to lower net cash flows from operating activities. Q3 priority brands Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including: Kisqali (USD 1 821 million, +37% cc) continued to grow strongly across all regions, with market share growth in early breast cancer and leadership in metastatic breast cancer. Kesimpta (USD 1 484 million, +22% cc) sales showed continued strong momentum globally, driven by increased demand and broad access. Scemblix (USD 593 million, +67% cc) sales grew across all regions, with continued strong momentum in the early-line setting in the US, Japan and Germany. L eqvio (USD 506 million, +63% cc) sales grew across all regions, with continued uptake in China following NRDL inclusion. Cosentyx (USD 1 857 million, +9% cc) sales grew in most markets, driven by the HS and SpA indications. US growth benefited from prior-year revenue deduction adjustments. P luvicto (USD 674 million, +20% cc) sales showed continued strong demand driven by the mAPMR¹ setting, with US and China approvals in mAPMN/S² in Q3, and ongoing access expansion ex-US. Zolgensma Group (USD 404 million, +35% cc) sales grew strongly, reflecting continued launch momentum from Itvisma in the US, Japan and other ex-US countries. R hapsido (USD 101 million) continued to show strong launch uptake in the US, supported by sustained prescription growth and a free drug program facilitating patient access. Ex-US, sales were mainly driven by early launch uptake in Germany and China. F abhalta (USD 237 million, +60% cc) sales grew, with expansion in PNH and renal indications. 1 Metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), also known as metastatic castration resistant prostate cancer (mCRPC). ² Metastatic androgen pathway modulation-naïve or sensitive prostate cancer (mAPMN/S), also known as metastatic hormone-sensitive prostate cancer (mHSPC). Net sales of the top 20 brands in the third quarter and nine months Q3 2026 % change 9M 2026 % change USD m USD cc USD m USD cc Cosentyx 1 857 9 9 5 247 8 6 Kisqali 1 821 37 37 5 032 45 44 Kesimpta 1 484 21 22 4 072 27 26 Entresto 1 165 -38 -38 3 651 -44 -45 Pluvicto 674 20 20 1 967 42 41 Jakavi 564 5 5 1 697 9 6 Tafinlar + Mekinist 570 4 4 1 644 -2 -4 Ilaris 591 25 26 1 616 18 17 Scemblix 593 66 67 1 588 78 78 Leqvio 506 64 63 1 438 67 63 Zolgensma Group 404 34 35 1 071 16 13 Xolair 331 -25 -25 1 061 -21 -23 Sandostatin Group 311 3 3 900 -2 -4 Lutathera 219 3 3 655 7 6 Fabhalta 237 59 60 631 80 79 Exforge Group 183 4 1 577 6 2 Promacta/Revolade 142 -61 -61 505 -64 -65 Diovan Group 137 -4 -6 447 0 -3 Tasigna 141 -36 -37 438 -53 -54 Piqray/Vijoice 122 36 37 326 8 8 Top 20 brands total 12 052 7 7 34 563 3 1 R&D update – key developments from the third quarter New approvals Rhapsido (remibrutinib) In October, FDA approved Rhapsido as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines, expanding its use beyond chronic spontaneous urticaria (CSU) into chronic inducible urticaria (CIndU). Novartis plans to submit the full RemIND dataset to health authorities globally. Pluvicto (lutetium Lu177 vipivotide tetraxetan) FDA and China’s NMPA approved Pluvicto in combination with an androgen receptor pathway inhibitor (ARPI) for patients with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer¹. Pluvicto is now approved across all stages of PSMA+ metastatic prostate cancer. Fabhalta (iptacopan) Japan’s MHLW approved Fabhalta for the treatment of IgA nephropathy (IgAN), making it the first approved treatment for this indication in Japan. Additionally, FDA granted traditional approval of Fabhalta in IgAN. ¹ Also known as metastatic hormone-sensitive prostate cancer (mHSPC). Regulatory updates Cosentyx (secukinumab) CHMP adopted a positive opinion recommending approval for Cosentyx in polymyalgia rheumatica (PMR), based on positive Phase III REPLENISH data. If approved, Cosentyx will be the first IL-17A inhibitor approved in Europe for PMR. DAK539 (pelabresib) Regulatory submission for pelabresib in myelofibrosis was completed in the EU, based on the positive Phase III MANIFEST-2 study, which showed deep and durable disease control, with a safety pro to ruxolitinib alone, including numerically fewer deaths and disease progressions in the pelabresib arm. KPE179 (del-zota) Del-zota was granted priority review by FDA for people living with Duchenne muscular dystrophy who have a genetic variant that may be amenable to exon 44 skipping (DMD44). Del-zota previously received FDA Breakthrough Therapy designation. Leqvio (inclisiran) FDA updated the Leqvio label to include language recognizing that lowering LDL-C reduces the risk of major adverse cardiovascular events (MACE) in adults at increased cardiovascular risk. This update reflects established evidence from statins and monoclonal antibody PCSK9 inhibitors, supporting LDL-C reduction as a key component of cardiovascular risk management. Vanrafia (atrasentan) Regulatory submissions for Vanrafia in IgAN were completed in Japan and China. KLU156 (ganaplacide + lumefantrine) Regulatory submission for KLU156 in uncomplicated malaria was completed in the US and received priority review. Results from ongoing trials and other highlights LOU064 (remibrutinib) Positive results from the Phase III REMODEL-1 and -2 trials showed oral remibrutinib met its primary endpoint in relapsing multiple sclerosis (RMS), significantly reducing annualized relapse rate (ARR) versus teriflunomide. Remibrutinib also showed superiority on all key secondary endpoints, including MRI lesion reduction, and a clinically meaningful delay in disability progression. The safety pro favorable and consistent with remibrutinib in CSU, with no liver safety signal. Data were presented at MSToronto2026 in October. EWF980 (del-desiran) In the Phase III HARBOR study, del-desiran did not meet its primary endpoint of video hand opening time (vHOT) versus placebo in myotonic dystrophy type 1 (DM1). Evidence of clinical activity was observed in secondary endpoints and exploratory analyses. Novartis is evaluating the full HARBOR dataset and will engage with health authorities to determine the most appropriate development path. Data will be presented at an upcoming medical congress. TQJ230 (pelacarsen) In the Phase III HORIZON trial, pelacarsen did not meet its primary endpoint of reducing the risk of cardiovascular events versus placebo in patients with elevated Lp(a) and established cardiovascular disease (CVD), despite reducing Lp(a) levels in this study population. The findings provide important new evidence on the relationship between Lp(a) lowering and cardiovascular outcomes and may help inform future approaches to cardiovascular risk management. Data will be presented at an upcoming medical congress. Kisqali (ribociclib) The six-year follow-up analysis of the Phase III NATALEE trial showed a clinically meaningful overall survival (OS) benefit with Kisqali plus endocrine therapy (ET) versus ET alone in the broadest HR+/HER2- early breast cancer (eBC) population at high risk of recurrence, reducing the risk of death by nearly 20%. Patients had been off Kisqali treatment for a median of 38 months, with clinical benefit continuing to deepen after treatment completion. The safety pro consistent with previous analyses. Data were presented at ESMO 2026. LOU064 (remibrutinib) Novartis has discontinued the Phase III study of remibrutinib in generalized myasthenia gravis (gMG) following a futility analysis, which indicated the treatment was unlikely to meet its efficacy objectives. No safety concerns were identified, and there is no impact on remibrutinib studies in other indications. Selected transactions Novartis completed the acquisition of Myricx Bio, strengthening the oncology pipeline with a new class of antibody-drug conjugates (ADCs), including two lead assets targeting B7-H3 and HER2, as well as a broader payload platform with potential impact across multiple solid tumor settings. Novartis exercised its exclusive option to acquire full global rights to Sironax's proprietary Brain Delivery Module (BDM) platform, a next-generation blood-brain barrier crossing technology with the potential to transform the treatment of central nervous system diseases. Novartis entered into an exclusive global licensing agreement with BoomRay Pharmaceuticals for an undisclosed preclinical radioligand therapy asset, further strengthening its radioligand therapy portfolio. In October, Novartis entered into a strategic licensing and option agreement with Abogen Biosciences to advance RNA-encoded therapeutics, including an exclusive worldwide license to ABO2203, a novel mRNA-encoded CD19xCD3 T-cell engager with the potential to transform the treatment landscape for autoimmune diseases. The transaction is subject to the completion of customary closing conditions. Capital structure and net debt Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority. During the first nine months of 2026, Novartis repurchased 30.9 million shares for USD 4.7 billion on the SIX Swiss Exchange second trading line. These repurchases included 18.8 million shares (USD 2.8 billion) under the up-to USD 10 billion share buyback announced in July 2025 (with up to USD 4.9 billion still to be executed). In addition, 12.1 million shares (USD 1.8 billion) were repurchased to mitigate the anticipated full-year dilution related to participation plans of employees. Further, 2.0 million shares (USD 0.3 billion) were repurchased from employees. During the same period, USD 0.9 billion of equity-based compensation plan expenses were recognized to equity and 13.3 million shares were delivered to employees related to equity-based compensation plans from prior years. As a result, the total number of shares outstanding decreased by 19.6 million compared with December 31, 2025. These treasury share transactions resulted in an equity decrease of USD 4.1 billion and a cash outflow of USD 4.8 billion. Net debt increased to USD 37.4 billion at September 30, 2026, compared with USD 21.9 billion at December 31, 2025. The increase was mainly due to the free cash flow of USD 14.0 billion being more than offset by the net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 16.7 billion, the USD 9.1 billion annual dividend payment and cash outflows for treasury share transactions of USD 4.8 billion. As of Q3 2026, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2026 outlook Barring unforeseen events; growth vs. prior year in cc Net sales Expected to grow low single-digit Core operating income Expected to be in line to grow low single-digit (from decline low single-digit) Foreign exchange impact If late-October exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 1 percentage point on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. 2027 Annual General Meeting Nomination for election to the Board of Directors The Novartis Board of Directors announced today that it is nominating Rajesh Jha for election to the Board. During a 36-year career at Microsoft, Mr. Jha held a series of senior leadership roles across software engineering, productivity platforms and enterprise technologies, and served on the company's Senior Leadership Team from 2016 until his retirement. Most recently, he served as Executive Vice President, Experiences + Devices, where he led the product teams for Microsoft 365, Office, Teams, Windows + Devices, and Dynamics, and played a key role in the integration of artificial intelligence across Microsoft's product portfolio. His extensive experience in technology, AI and large-scale digital platforms would add significantly to the Novartis Board of Directors. Key figures¹ Q3 2026 Q3 2025 % change 9M 2026 9M 2025 % change USD m² USD m² USD cc USD m² USD m² USD cc Net sales 14 522 13 909 4 4 42 043 41 196 2 0 Operating income 1 843 4 501 -59 -61 10 828 14 028 -23 -24 As a % of sales 12.7 32.4 25.8 34.1 Net income 1 196 3 930 -70 -71 7 609 11 563 -34 -35 EPS (USD) 0.63 2.04 -69 -70 4.01 5.94 -32 -33 Net cash flows from operating activities 5 503 6 571 -16 15 061 16 880 -11 Non-IFRS measures Free cash flow 5 111 6 217 -18 14 002 15 941 -12 Core operating income 6 036 5 460 11 10 16 873 16 960 -1 -2 As a % of sales 41.6 39.3 40.1 41.2 Core net income 4 655 4 330 8 6 13 027 13 522 -4 -5 Core EPS (USD) 2.46 2.25 9 8 6.85 6.94 -1 -3 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 45 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. USD millions unless indicated otherwise. Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below: Disclaimer This communication contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “expected,” “anticipated,” “can,” “will,” “continue,” “ongoing,” “growth,” “launch,” “expanding,” “deliver,” “accelerate,” “guidance,” “outlook,” “priority,” “potential,” “momentum,” “on track,” “pipeline,” “evidence,” “progress,” “emerging,” or similar expressions, or by express or implied discussions regarding: potential new products, potential new indications for existing products, potential product launches or potential future revenues from any such products; or results of ongoing clinical trials; potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 communication 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. Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this communication will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of key products, commercial priorities and strategy; the research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; the implementation of our new IT projects and systems; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this communication; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis. 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 and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . Novartis will conduct a conference call with investors to discuss this news release today at 13:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting . Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at . Important dates November 18-19, 2026 Meet Novartis Management 2026 (London, UK) February 3, 2027 Fourth quarter & full year 2026 results March 5, 2027 Annual General Meeting # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com Please find full media release in English attached and on the following link: Media release (PDF) Further language versions are available through the following links: German version is available through the following link: Medienmitteilung (PDF)

Phase 3Clinical ResultDrug ApprovalBreakthrough TherapyLicense out/in

26 Oct 2026

·www.fiercebiotech.com

Lycia leaps onto Nasdaq with upsized $318M IPO as Windward breezes toward listing

Lycia Therapeutics went public with an upsized $317.5 million IPO on Friday, while immunology-focused Windward Bio has also seen which way the public markets are blowing. South San Francisco-based Lycia offered 17.6 million shares as part of its Friday listing —above the 14.7 million shares that the company had previously expected . At $18 apiece, the shares also came in at the top end of the anticipated range. That means Lycia raised $317.5 million in gross proceeds from the IPO, well above the roughly $250 million it had initially targeted. The haul could rise by another $47.6 million if underwriters fully exercise their 30-day option to buy an additional 2.6 million shares at the same price. Lycia's stock began trading under the ticker symbol “LYCA,” ending its first day up nearly 67% at $30 per share. The company explained last week that it needs around $80 million to take its lead asset, LCA-0061, through a phase 2 study. LCA-0061 is a catalytic lysosomal targeting chimera (cataLYTAC) degrader designed to deplete immunoglobulin E (IgE) to treat food allergies and other allergic diseases. A further $70 million is due to be set aside to take a “fast follower” cataLYTAC degrader called LCA-0062 into its own phase 2 study for food allergies. The hope is that LCA-0062 will offer “additional flexibility in dosing and duration of response” compared with its predecessor, LCA-0061. In a filing last week, Lycia noted that IgE blockers like Novartis and Genentech’s Xolair have benefited patients with food allergies, but suggested these therapies “remain constrained by weight-based and often cumbersome dosing schedules, as well as limitations in patients with high circulating IgE levels.” Xolair and its ilk only inhibit IgE, rather than removing it entirely, Lycia pointed out in the filing. In contrast, LCA-0061 is “designed with an aim to eliminate total and free IgE by targeting extracellular IgE for lysosomal degradation.” Preliminary data from an ongoing phase 1 trial of LCA-0061 have backed up this theory, according to Lycia, demonstrating “rapid, deep and sustained reduction in total and free IgE, with no safety signals or dose-limiting toxicities observed.” Beyond food allergies, Lycia said it needs $90 million for a midstage study of LCA-0321, a LYTAC degrader for Graves’ disease. The therapy is designed to selectively degrade TRAbs, the pathogenic drivers of Graves’ disease. Lycia’s workforce of 31 full-time employees is headed up by CEO Aetna Wun Trombley, Ph.D., a former chief operating officer of liver disease-focused NGM Biopharmaceuticals. Having launched with $50 million in 2020 before raising a $70 million series B in 2021, a $106.6 million series C in 2024 and a $75 million fundraise in June, the company entered the second half of this year with $148.1 million in cash, cash equivalents and marketable securities. As Lycia leaped onto the Nasdaq, Windward disclosed that it’s mulling a similar move. The Swiss biotech has yet to set out exactly how many shares it expects to offer or at what price, but explained in its filing that its top spending priority will be WIN378. Windward acquired the rights to the anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody from Kelun-Biotech and Harbour BioMed in a $970 million biobucks deal last year. Since then, the biotech has taken the candidate into a phase 2 trial in chronic obstructive pulmonary disease (COPD) and a phase 2/3 trial in asthma. Cash is also needed for another phase 3 asthma trial that's expected to begin enrolling patients in the first half of 2027. Meanwhile, more money is required to fund a planned phase 2b study of WIN027 in COPD, as well as take that drug into a global midstage trial for atopic dermatitis. Windward also acquired that asset from China last year, penning a $700 million deal with Qyuns Therapeutics for the IgG1 bispecific monoclonal antibody that targets both human thymic stromal lymphopoietin (TSLP) and human interleukin-13 (IL-13). Some of the IPO cash is also due to be set aside to advance the company’s preclinical bispecific programs. These are headed up by a next-gen bispecific targeting both type 2 (T2) and non-T2 inflammatory pathways. The Basel-based biotech is headed up by CEO Luca Santarelli, M.D., who previously ran VectivBio and Therachon. VectivBio was bought by Ironwood Pharmaceuticals, while Therachon was acquired by Pfizer. Windward hasn’t had any problems bringing in funds in the past, having secured a $200 million series A in 2025 backed by the likes of Novo Holdings. The company followed that up with a $165 million series B earlier this year and still had $207.3 million in cash, cash equivalents and marketable securities at the end of June. The state of biotech funding is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

Phase 1Phase 2IPOAcquisitionImmunotherapy

26 Oct 2026

·www.fiercebiotech.com

Lycia aims for $228M IPO to generate data on food allergy rival to Xolair

Lycia Therapeutics is banking on a $227.8 million IPO as the biotech seeks to finance its pipeline of protein degraders for autoimmune, inflammatory and allergic diseases. The South San Francisco-based biotech already disclosed earlier this month that it is hoping to go public. In a Tuesday filing , Lycia explained it is aiming to sell 14.7 million shares priced between $16 and $18 apiece. Assuming the final price falls in the middle of this range, the biotech expects to rake in $227.8 million in net proceeds—rising to $262.7 million if underwriters take up their option to buy an additional 2.2 million shares at the same price. Lycia expects it will need around $80 million to take its lead asset LCA-0061 through a phase 2 study. LCA-0061 is a catalytic lysosomal targeting chimera (cataLYTAC) degrader designed to deplete immunoglobulin E (IgE) in order to treat food allergy and other allergic diseases. A further $70 million will be set aside to take a “fast follower” cataLYTAC degrader called LCA-0062 into its own phase 2 study for food allergy. The hope is that LCA-0062 will offer “additional flexibility in dosing and duration of response” to its predecessor, LCA-0061. In its filing, Lycia noted that IgE blockers like Novartis and Genentech’s Xolair have benefited patients with food allergy, but suggested these therapies “remain constrained by weight-based and often cumbersome dosing schedules, as well as limitations in patients with high circulating IgE levels.” Xolair and its ilk only inhibit IgE, rather than removing it entirely, Lycia pointed out in the filing. In contrast, LCA-0061 is “designed with an aim to eliminate total and free IgE by targeting extracellular IgE for lysosomal degradation.” Preliminary data from an ongoing phase 1 trial of LCA-0061 has backed up this theory, according to Lycia, demonstrating “rapid, deep and sustained reduction in total and free IgE, with no safety signals or dose-limiting toxicities observed.” Beyond food allergy, Lycia said it needs $90 million for a mid-stage study of LCA-0321, a LYTAC degrader for Graves’ disease. The therapy is designed to selectively degrade TRAbs, the pathogenic drivers of Graves’ disease. Lycia’s workforce of 31 full-time employees is headed up by CEO Aetna Wun Trombley, Ph.D., a former chief operating officer of liver disease-focused NGM Biopharmaceuticals. Having launched with $50 million in 2020 before raising a $70 million series B in 2021, a $106.6 million series C in 2024 and a $75 million fundraise in June, the company entered the second half of this year with $148.1 million still in the bank. The state of biotech funding is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

Phase 1IPOPROTACs

100 Deals associated with Omalizumab

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KEGG	Wiki	ATC	Drug Bank
D05251	Omalizumab	R03DX05	DB00043

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Food Hypersensitivity	United States	Genentech, Inc.	16 Feb 2024
Nasal Polyps	United States	Genentech, Inc.	30 Nov 2020
Rhinitis, Allergic, Seasonal	Japan	Novartis Pharmaceuticals KK	11 Dec 2019
Asthma	United States	Genentech, Inc.	20 Jun 2003
Allergic asthma	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic rhinosinusitis with nasal polyps	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002
Chronic Urticaria	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Jun 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lung Diseases, Obstructive	NDA/BLA	Canada	Advanz Pharma Corp.	01 Apr 2026
Chronic sinusitis	NDA/BLA	China	Beijing Novartis Pharma Co., Ltd.	19 Jul 2022
Chronic sinusitis	NDA/BLA	China	Novartis Europharm Ltd.	19 Jul 2022
Peanut Hypersensitivity	Phase 3	United States	Genentech, Inc.	22 Jul 2019
Peanut Hypersensitivity	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Jul 2019
Bronchitis	Phase 3	Canada	Novartis AG	01 Mar 2014
Angioedema	Phase 3	Germany	Novartis Pharmaceuticals Corp.	23 Jan 2013
Severe persistent asthma	Phase 3	France	Novartis Pharmaceuticals Corp.	01 Sep 2009
Seasonal allergic conjunctivitis	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Feb 2006
Persistent asthma	Phase 3	-	Genentech, Inc.	01 Jul 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03679676 (COMBINE, CTgov)	Phase 2	Peanut Hypersensitivity	130	Placebo+Dupilumab+Omalizumab (Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy)	hwxxeqlcwt = ibvxhjzwkc btxcggkybb (qrhlbmylli, reowsivwlc - vnwmfsobxw) View more	-	29 May 2026
				Dupilumab+Omalizumab (Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy)	hwxxeqlcwt = bsxbasehif btxcggkybb (qrhlbmylli, aecqlkcmvt - mwcuzvwduq) View more
ATS2026	Not Applicable	Severe asthma	22	Xolair 600 mg	jklvmhwpea(uclnaevuvf) = ipwskrkgcy hujfqkpzql (czmdgclapl, 3.34) View more	Positive	15 May 2026
ATS2026	Not Applicable	Severe asthma	465	Biologic therapies	gxjsoeyojg(psiltkxftl) = ylbgogejhc gknttdrtnd (mwunwnzhwr, 29.5 - 38.3) View more	Positive	15 May 2026
ATS2026	Not Applicable	Severe asthma	13	Omalizumab 300 mg	vnkupnwcnx(oglegshsdm) = Both MMRC and ACQ-5 scores showed symptomatic improvement mjgkefmezc (inlupqohbe ) View more	Positive	15 May 2026
ATS2026	Not Applicable	Food Hypersensitivity \| Vernal Keratoconjunctivitis \| Chronic Urticaria ... View more	88	Omalizumab	ffyvqgvphp(lswnbzirul) = vumzmelybr mqaypjhojo (wkymiwhnvu ) View more	Positive	15 May 2026
				Dupilumab	nwwjsgeswd(mtbaubswlv) = uweqftceys uxgskihzkr (kwkaljahwg ) View more
NCT01287117 (ASTERIA I, Pubmed \| J Allergy Clin Immunol Glob)	Phase 3	Chronic Urticaria	-	Omalizumab	bybnhetrgt(grckjokpvr) = kgjuuwbipx qoueuypxuc (snslseydrz, -6.9 to -4.0) View more	Positive	01 May 2026
				Dupilumab	bybnhetrgt(grckjokpvr) = rvxcpczcca qoueuypxuc (snslseydrz, -4.6 to -0.1) View more
AAD2026	Not Applicable	Alopecia Areata	13	Baricitinib or Upadacitinib (Atopic Background + Alopecia Areata)	aqytevvitt(eifsttkhrb) = mlmcclibvc qkiydmebht (rvicdfninm ) View more	Positive	27 Mar 2026
AAD2026	Not Applicable	Chronic Urticaria	48	Omalizumab (Discontinuation for more than five half-lives)	wmklmmvnms(ylqtqqpiob) = xbrnevjnlf nefypkugre (rnvgnvbuva, 23.4 - 83.3)	Positive	27 Mar 2026
				Omalizumab (No significant breaks in treatment)	wmklmmvnms(ylqtqqpiob) = npqigulcsd nefypkugre (rnvgnvbuva, 29.5 - 58.8)
AAD2026	Not Applicable	Chronic Urticaria \| Dermatitis, Atopic	128	Omalizumab	vrfsrzycvy(jtvpcaudli) = libyjtsaqo bybbrthndh (sywkcegvnb ) View more	Positive	27 Mar 2026
AAAAI2026	Not Applicable	Childhood asthma	2,590	Dupilumab	igbjtttdhq(vuyisuiapz) = bbdeuxgith iiiptuggoz (etofunjzla, -23.08 to -18.06)	Positive	27 Feb 2026
				Omalizumab	igbjtttdhq(vuyisuiapz) = gmncwqyrey iiiptuggoz (etofunjzla, -27.39 to -13.08)

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