An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

Start Date13 Jun 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06431750

/ Not yet recruitingNot Applicable

Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)

This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis

Start Date30 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06905288

/ RecruitingNot Applicable

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.

Start Date02 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Secukinumab

100 Translational Medicine associated with Secukinumab

100 Patents (Medical) associated with Secukinumab

2,245

Literatures (Medical) associated with Secukinumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of generalized pustular psoriasis during pregnancy with secukinumab in a patient hypersensitive to spesolimab: a case report

Article

Author: Zhang, Yun ; Peng, Guoyao ; Nie, Xinyi ; Zhang, Hongwei ; Yu, Tao ; Liao, Chengcheng ; Li, Xia ; Xiang, Jie ; Luo, Jiaxin ; Luo, Liping ; Li, You ; Zhang, Shuang

OBJECTIVE:

Generalized pustular psoriasis (GPP) is a rare autoinflammatory skin disease characterized by recurrent, widespread eruption of sterile pustules rich in neutrophils. In addition to skin manifestations, this condition may be accompanied by fever, muscle pain, joint pain, systemic inflammation, or organ failure. GPP during pregnancy poses a serious threat to both mother and fetus, with limited options for medication. This study aimed to evaluate the safety of secukinumab during pregnancy as a treatment option for psoriasis.

MATERIALS AND METHODS:

We report the case of a 35-year-old pregnant woman presenting with extensive, confluent erythematous scaly plaques and numerous pustules, accompanied by fever. Over the past few years, her lesions showed remission following treatment with corticosteroids, traditional Chinese medicine, and secukinumab. However, after a brief remission with spesolimab, the lesions recurred and no significant improvement was obtained with glucocorticoid therapy. Secukinumab treatment was then initiated.

RESULTS:

Secukinumab was administered subcutaneously at a dose of 300 mg at weeks 0, 1, 2, 3, 4, and 8. Following treatment, GPP symptoms were reduced, and fetal development remained normal. A healthy boy was delivered vaginally at term.

CONCLUSION:

Our findings provide evidence that secukinumab is an effective and safe treatment option for GPP during pregnancy.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Global research trends in biological therapy for ankylosing spondylitis: A comprehensive visualization and bibliometric study (2004–2023)

Article

Author: Yang, Haicheng ; Wu, Zixiang ; He, Weiliang ; Huang, JinFeng ; Yang, Xuanzhe

Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the spine and pelvic bones. Recently, many researchers have confirmed that biological therapy is effective for AS patients, which provides a new perspective for the treatment of AS. This study aimed to evaluate the characteristics of scientific research on AS and biological therapy worldwide and investigate research hotspots and the direction of future trends. Global literature on AS and biological therapy published from 2004 to 2023 was searched in the Web of Science, Scopus, and PubMed databases. Visualization and bibliometric analysis were carried out using the VOSviewer and CiteSpace software with the retrieved data regarding countries, institutions, journals, authors, and keywords. A total of 2,243 related articles were included, showing that the number of articles in this field has increased annually. The highest number of articles were from the USA (24.39%), followed by Italy (14.36%), England (12.19%), Germany (10.66%), and Spain (7.86%). Braun J was the most prolific author, with a h-index of 16. The institution with the most articles was Charite Universitatsmedizin Berlin, and the Rheumatology journal had the highest number of publications. "janus kinase inhibitor" and "secukinumab" displayed a notable citation burst in recent years, indicating IL-17i and JAKi are research hotspots. More and more attention has been paid to the association between AS and biological therapy in the past two decades. The USA plays a leading role, and China has made remarkable progress. This study has provided a valuable reference for future research in this field.

01 Dec 2025·IMMUNOLOGIC RESEARCH

Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study

Article

Author: Kraner Šumenjak, Tadeja ; Merzel Šabović, Eva Klara ; Božič Mijovski, Mojca ; Janić, Miodrag

Abstract:

Psoriasis is a chronic, immune-mediated disease. The systemic inflammation triggered by psoriasis contributes significantly to increased cardiovascular risk. While various treatments completely clear the skin, the associated effects on systemic inflammation are not yet clear. We investigated residual systemic inflammation in successfully treated patients. Circulating disease-specific and non-specific inflammatory markers were measured and compared in 80 psoriasis patients (aged 30–45 years) successfully treated with topical therapy, methotrexate, adalimumab, secukinumab or guselkumab, and in 20 healthy controls. Non-specific inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), complete blood count (CBC) parameters, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume-to-platelet ratio (MPR), and red blood cell distribution width-to-platelet ratio (RPR)) and disease-specific inflammatory markers (interferon-γ (IFN-γ), tumor necrosis factor (TNF), interleukin (IL)-1β, IL-12p70, IL-17, and IL-23) were measured and compared between groups. Disease-specific cytokines (IFN-γ, TNF, IL-1β, IL-12p70, and IL-17, but not IL-23), were significantly elevated in patients compared to controls, while non-specific inflammatory markers showed no differences compared to controls. The residual disease-specific cytokines were similarly elevated in all five treated groups. In addition, they correlated significantly with body mass index (BMI) and waist circumference. Our results suggest that psoriasis patients have elevated residual disease-specific cytokines despite successful treatment, while the non-specific inflammatory markers are similar to those in control subjects. Residual disease-specific inflammatory markers correlated with BMI and waist circumference. A possible beneficial effect of body weight control in psoriasis patients merits further investigation. The study was registered at http://clinicaltrials.gov (identifier: NCT05957120) on July 24, 2023.

260

News (Medical) associated with Secukinumab

29 Apr 2025

·www.globenewswire.com

Novartis continues strong momentum with double-digit sales growth, robust margin expansion and multiple approvals in Q1

Ad hoc announcement pursuant to Art. 53 LR Net sales grew +15% (cc1, +12% USD) with core operating income1 up +27% (cc, +23% USD) Sales growth driven by continued strong performance from Entresto (+22% cc), Kisqali (+56% cc), Kesimpta (+43% cc), Cosentyx (+18% cc), Leqvio (+72% cc) and Scemblix (+76% cc) Core operating income margin1 reached 42.1%, +400 basis points (cc), mainly driven by higher net sales Operating income grew +44% (cc, +38% USD); net income up +37% (cc, +34% USD)Core EPS1 grew +31% (cc, +27% USD) to USD 2.28Free cash flow1 of USD 3.4 billion (+66% USD) driven by higher net cash flows from operating activities Selected innovation milestones: Pluvicto FDA approval for pre-taxane mCRPC Vanrafia (atrasentan) FDA accelerated approval for IgA nephropathy Fabhalta (iptacopan) FDA, EC and China NMPA approvals for C3G Remibrutinib global submissions for CSU, with priority review voucher in US OAV101 IT Phase III STEER study positive readout in SMA Full-year 2025 guidance2 raised: Sales expected to grow high single digit, core operating income expected to grow low double-digit Basel, April 29, 2025 – Commenting on Q1 2025 results, Vas Narasimhan, CEO of Novartis, said:“Novartis has had a strong start to the year, delivering a +15% cc increase in sales and a +27% cc rise in core operating income in Q1. Our priority brands, including Kisqali, Kesimpta and Leqvio, continue to show strong momentum, which we anticipate will drive our growth through 2030 and beyond. We also achieved significant innovation milestones in the quarter, with new approvals for Pluvicto in the pre-taxane setting, Vanrafia for IgA nephropathy, and Fabhalta for C3G. Additionally, we completed global submissions for remibrutinib in CSU, the first indication for this promising pipeline-in-a-pill. We remain focused on advancing our leading pipeline and confident in achieving our growth outlook.” Key figures Q1 2025Q1 2024% change USD m USD mUSDccNet sales to third parties13 23311 8291215Operating income4 6633 3733844Net income3 6092 6883437EPS (USD)1.831.314042Free cash flow3 3912 03866 Core operating income5 5754 5372327Core net income4 4823 6812226Core EPS (USD)2.281.802731 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 31 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 5. 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 Net sales were USD 13.2 billion (+12%, +15% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a positive impact of 2 percentage points, benefiting from revenue deduction adjustments mainly in the US. Operating income was USD 4.7 billion (+38%, +44% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Net income was USD 3.6 billion (+34%, +37% cc), mainly driven by higher operating income, partly offset by higher income taxes. EPS was USD 1.83 (+40%, +42% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.6 billion (+23%, +27% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches, and R&D investments. Core operating income margin was 42.1% of net sales, increasing 3.7 percentage points (4.0 percentage points cc). Core net income was USD 4.5 billion (+22%, +26% cc), mainly due to higher core operating income. Core EPS was USD 2.28 (+27%, +31% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 3.4 billion (+66% USD), compared with USD 2.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities. Q1 priority brands Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q1 growth) including: Entresto(USD 2 261 million, +22% cc) sustained robust, demand-led growth globally, including in China and Japan with increased penetration in hypertensionKisqali(USD 956 million, +56% cc) sales grew strongly across all regions, including +87% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancerKesimpta(USD 899 million, +43% cc) sales grew across all regions driven by increased demand and strong accessCosentyx(USD 1 534 million, +18% cc) sales grew mainly in the US, emerging growth markets and Europe, driven by recent launches as well as volume growth in core indicationsLeqvio(USD 257 million, +72% cc) continued steady growth, with a focus on increasing account and patient adoption, and continuing medical educationScemblix(USD 238 million, +76% cc) sales grew across all regions, demonstrating the continued high unmet need in CML and strong momentum from the recently launched early-line indication in the USFabhalta(USD 81 million) sales grew driven by continued launch execution across all markets in PNH as well as the recent launch in IgAN in the USPluvicto(USD 371 million, +21% cc) continued stable performance in the US and grew in Europe in the mCRPC post-taxane setting. With the FDA’s approval for earlier use before chemotherapy, which approximately triples the eligible patient population, the focus is on driving demand in established RLT sites while activating new sites and supporting referring providers to enable patient accessZolgensma(USD 327 million, +13% cc) sales grew as it continues to demonstrate strong performance in the incident populationLutathera(USD 193 million, +15% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier line adoption particularly in the US and Japan Net sales of the top 20 brands in the first quarter Q1 2025 % change USD mUSDccEntresto2 2612022Cosentyx1 5341618Kisqali 9565256Kesimpta 8994143Tafinlar + Mekinist 5521619Promacta/Revolade 54658Jakavi 49237Xolair 4561419Ilaris 4191820Tasigna 377-5-2Pluvicto 3712021Zolgensma 3271113Sandostatin Group 317-11-9Leqvio 2577072Scemblix 2387576Lutathera 1931415Lucentis 189-40-38Exforge Group 179-7-1Diovan Group 150712Galvus Group 124-17-11Top 20 brands total10 8371719 R&D update - key developments from the first quarter New approvals Pluvicto(lutetium Lu177 vipivotide tetraxetan)FDA expanded the indication for Pluvicto to include patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor and are considered appropriate to delay chemotherapy, approximately tripling the eligible patient population. Vanrafia(atrasentan)FDA granted an accelerated approval for Vanrafia for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy.Fabhalta(iptacopan)Fabhalta was approved by the US FDA, European Commission and China’s NMPA for adult patients with C3 glomerulopathy (C3G), making it the first and only treatment approved for this condition in all three markets. Regulatory updates RemibrutinibRegulatory submissions for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) were completed in the US, EU and China. A priority review voucher was used in the US and approval is anticipated in H2 2025, and priority review was granted in China. Scemblix(asciminib)Regulatory submission for Scemblix in adults with newly diagnosed CML was completed in the EU based on 96-week data from the Phase III ASC4FIRST study. Results from ongoing trials and other highlights OAV101 IT(onasemnogene abeparvovec)Novartis announced positive safety and efficacy results from the Phase III program for investigational intrathecal OAV101 IT in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA). In the Phase III STEER study, treatment with OAV101 IT led to a statistically significant and clinically meaningful 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded vs. 0.51 points in the sham control arm. In addition, in the Phase IIIb STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with nusinersen or risdiplam demonstrated stabilization of motor function over 52 weeks of follow-up. OAV101 IT demonstrated a favorable safety profile, consistent in both treatment-naïve and treatment-experienced patients. Data were presented at MDA.RemibrutinibThe New England Journal of Medicine published data from the 24-week double-blind placebo-controlled period of the Phase III REMIX-1 and -2 studies. Remibrutinib showed early symptom improvement and sustained efficacy, with improvements in CSU symptoms compared to placebo observed as early as week 1 and response rate maintained through the double-blind treatment period. Remibrutinib was well tolerated, with overall adverse event rates comparable to placebo. Multiple analyses of the REMIX-1 and -2 trials were presented at medical congresses in Q1. At AAAAI, long-term results showed that patients experienced improved urticaria control within two weeks of starting treatment. Patients who switched from placebo to remibrutinib at week 24 achieved similar improvements through week 52. At AAD, data was presented showing that treatment with remibrutinib had positive effects on sleep and daily activities for CSU patients.IanalumabThe results of Phase II VAYHIT3 study in adult patients with advanced primary ITP, previously treated with at least a corticosteroid and a thrombopoietin receptor agonist, indicate that a short course of ianalumab has clinically meaningful efficacy and is well tolerated in these patients. These results will be presented at a future medical meeting and are expected to support a filing in second-line ITP, based on the Phase III VAYHIT2 study, expected to read out in H2 2025.Selected transactionsNovartis has completed the acquisition of Anthos Therapeutics, a clinical-stage biopharmaceutical company developing abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathway in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The acquisition adds a Phase III asset and is aligned with the Novartis growth strategy and expertise in the cardiovascular therapeutic area. 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. In Q1 2025, Novartis repurchased a total of 24.8 million shares for USD 2.6 billion on the SIX Swiss Exchange second trading line under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 2.7 billion still to be executed). In addition, 1.5 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 10.5 million shares (equity value of USD 0.3 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 15.8 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 2.5 billion and a net cash outflow of USD 2.7 billion. Net debt increased to USD 22.3 billion at March 31, 2025, compared with USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 3.4 billion being more than offset by the USD 5.3 billion annual net dividend payment in March (which is the gross dividend of USD 7.8 billion reduced by the USD 2.5 billion Swiss withholding tax that was paid in April 2025, according to its due date), cash outflows for treasury share transactions of USD 2.7 billion and cash outflows for purchases of intangible assets of USD 1.2 billion. As of Q1 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2025 outlook Barring unforeseen events; growth vs. prior year in ccNet salesExpected to grow high single-digitCore operating incomeExpected to grow low double-digit Key assumptions: We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes Foreign exchange impact If late-April exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be 0 percentage points on net sales and negative 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Q1 2025Q1 2024% change USD m USD mUSDccNet sales to third parties13 23311 8291215Operating income4 6633 3733844As a % of sales35.228.5 Net income3 6092 6883437EPS (USD)1.831.314042Net cash flows from operating activities3 6452 26561 Non-IFRS measures Free cash flow 3 3912 03866 Core operating income5 5754 5372327As a % of sales42.138.4 Core net income4 4823 6812226Core EPS (USD)2.281.802731 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 31 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below:https://ml-eu.globenewswire.com/resource/download/f5843473-7c9e-4c13-b263-db739fdcf6d6/ DisclaimerThis press release 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 “anticipate,” “can,” “will,” “continue,” “ongoing,” “growth,” “launch,” “expect,” “expand,” “deliver,” “accelerate,” “deliver,” “guidance,” “outlook,” “priority,” “potential,” “momentum,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure. 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. You should not place undue reliance on these 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. Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this press release 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; uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in 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; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; uncertainties in the development or adoption of potentially transformational digital technologies, including artificial intelligence, and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; 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; uncertainties regarding future global exchange rates; uncertainties regarding 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 press release 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 nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X and Instagram. Novartis will conduct a conference call with investors to discuss this news release today at 14:00 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 https://www.novartis.com/investors/event-calendar. 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 https://www.novartis.com/investors/event-calendar. Important datesJuly 17, 2025October 28, 2025November 19-20, 2025Second quarter & half year 2025 resultsThird quarter & nine months 2025 resultsMeet Novartis Management 2025 (London, UK) Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-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)

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

24 Apr 2025

·www.biopharmadive.com

Versant startup Granite debuts with $100M and two immune drugs

Venture capitalists have been scouring the globe in search of better immunology drugs. Biotech startup creator Versant Ventures is among them, having formed and funded several companies in recent years looking to change the way certain inflammatory diseases are treated.Versant isnt done with that effort. On Thursday, the firm revealed its latest foray into immunology research a startup called Granite Bio thats already secured $100 million in funding and has two drugs either in, or nearing, clinical testing.Granite is a product of Ridgeline Therapeutics, part of an initiative Versant hatched more than a decade ago to help turn scientific discoveries into new companies. Operating in stealth mode, the company raised a $30 million Series A led by Versant and Novartis venture arm in 2021 and a $70 million Series B from Forbion and Sanofis venture fund two years later.The startup is working on two antibody drugs for inflammatory conditions. One, dubbed GRT-001, is being developed for inflammatory bowel disease and is currently in Phase 1 testing in healthy volunteers, with a trial in ulcerative colitis patients expected later this year. Another, GRT-002, is seen as a new way to potentially treat itch and allergies and should start its first trial in 2026.GRT-001 homes in on white blood cells called pro-inflammatory monocytes, which are part of the immune systems response to infections and inflammation. According to Granite CEO Patrick Loustau, this approach targets the “cellular source“ of IBD and has the potential to “reset“ patients' immune systems, which could lead to better and longer-lasting results than existing therapies.Monocyte depleters could have a similar impact on the innate immune system as B-cell targeting drugs appear to have on the adaptive part of the bodys defenses, giving them the potential to treat a range of inflammatory conditions,Loustau wrote in an email to BioPharma Dive.Granites other drug, GRT-002, homes on IL-3, a different inflammatory cytokine than the ones targeted by drugs like Dupixent and Cosentyx. Granite, in a statement announcing its launch, noted how IL-3 is a key player in autoimmunity as well as a kind of immune response called type 2 inflammation.Versant has started up several immune disease-focused biotechsof late. In 2024 alone, the firm formed Santa Ana Therapeutics, a developer of targeted immune therapies, as well as Borealis Biosciences, which is focused on medicines for inflammatory kidney diseases.Immunology investments more than doubled last year, surging to about $3.1 billion among the private rounds involving the prominent venture firms tracked by BioPharma Dive. Theyre on a similar trajectory in 2025, with about $1 billion raised so far. '

ImmunotherapyPhase 1

09 Apr 2025

·www.echemi.com

Novartis Launches Bold Attack Eyes 100 Billion Dollar Autoimmune Market

Novartis has reignited its competitive streak, targeting the reign of Dupixent (dupilumab), the newly crowned “autoimmune drug king” from Sanofi. The company has initiated a head-to-head Phase III trial for its investigational BTK inhibitor remibrutinib against Dupixent, aiming to disrupt the dominance of this top-tier therapeutic. This is not Novartis’ first strike at market leaders. In the past, its blockbuster Cosentyx (secukinumab) outperformed AbbVie's Humira and Johnson & Johnson’s Stelara in direct head-to-head trials, cementing its position as a key player in psoriasis treatment. However, despite these wins, Novartis’ 2024 autoimmune business revenue of $9.293 billion left it short of the $10 billion milestone and outside the top three in the field. Industry giants such as AbbVie, Johnson & Johnson, and Sanofi dominate the autoimmune space with super blockbuster drugs. AbbVie leads with a commanding $11.7 billion in Skyrizi sales and strong growth from Rinvoq, while Johnson & Johnson relies on products like Stelara and Tremfya. Sanofi, with Dupixent achieving $14.2 billion in sales, has solidified its position as the third-largest player in the sector. Novartis, though just shy of the $10 billion mark, is not backing down. Cosentyx, its flagship IL-17A inhibitor, has driven significant revenue growth, reaching $6.141 billion in 2024 sales, thanks to approvals for multiple indications like plaque psoriasis and psoriatic arthritis. Expansion into conditions such as polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), with Phase III trial results expected in 2025, could further elevate its market potential to $8 billion in peak sales. Yet, its other autoimmune drugs lag behind. Xolair (omalizumab), co-developed with Roche, generated $1.643 billion outside the US, but faces increasing pressure from Dupixent, which is now approved for chronic spontaneous urticaria (CSU) in Japan and awaiting FDA approval. Additionally, Chinese competitors are advancing innovative IgE-targeting therapies, challenging Xolair’s dominance. To counter these threats, Novartis has taken bold steps. It became the first company to file for remibrutinib’s approval in CSU treatment in China and has begun the RECLAIM Phase III trial, comparing remibrutinib directly with Dupixent. As a highly selective, oral, and irreversible BTK inhibitor, remibrutinib offers convenience over injectable biologics, with Novartis projecting $3 billion in peak sales. Additionally, Novartis secured an $830 million deal with Kyorin Pharmaceutical to develop MRGPRX2 antagonists like KRP-M223, targeting allergic and inflammatory mast cell diseases such as CSU. This emerging class of drugs represents a blue ocean market, with few competitors currently in clinical trials. Novartis is also advancing a robust autoimmune pipeline, with 15 early-stage and 8 late-stage clinical programs exploring diverse mechanisms, including NLRP3 inhibitors, CD19 CAR-T therapies, and BAFF-R monoclonal antibodies. Analysts suggest that Novartis’ strategy of head-to-head trials, pipeline diversification, and strategic licensing could help secure its place in the $100 billion autoimmune market. While challenges remain, including strong competition from Sanofi and Johnson & Johnson, Novartis’ aggressive moves could reshape the landscape, positioning it as a leading force in the autoimmune sector.

Phase 3Drug ApprovalLicense out/inImmunotherapy

100 Deals associated with Secukinumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09967	Secukinumab	L04AC10	DB09029

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pustular psoriasis	Japan	Novartis Pharma KK	21 Dec 2015
Ankylosing Spondylitis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Axial Spondyloarthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Enthesitis-Related Arthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Hidradenitis Suppurativa	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Juvenile Idiopathic Arthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Non-radiographic axial spondyloarthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Plaque psoriasis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Arthritis, Psoriatic	Japan	Novartis Pharma KK	26 Dec 2014
Psoriasis vulgaris	Japan	Novartis Pharma KK	26 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polymyalgia Rheumatica	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Japan	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Chile	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Colombia	Novartis Pharmaceuticals Corp.	22 Mar 2023
Polymyalgia Rheumatica	Phase 3	Czechia	Novartis Pharmaceuticals Corp.	22 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P3-2.007 (AAN2025)	Not Applicable	Maintenance NA	1	Secukinumab	fwohwdtxfk(xjwlntosof) = olfylnejhc sqwxnikdbe (injkizdxck ) View more	-	07 Apr 2025
NCT04737330 (ORBIT, CTgov)	Phase 3	Graves Ophthalmopathy	28	Secukinumab (Secukinumab 300 mg)	vdaocmeyzp(lnwbvpunid) = nqggegcsve cwylgxgeps (mrvxnlqkag, 0.58) View more	-	09 Jan 2025
				Placebo (Placebo)	vdaocmeyzp(lnwbvpunid) = rjivbgcest cwylgxgeps (mrvxnlqkag, 0.47) View more
NCT04179175 (SUNSHINE and SUNRISE extension trial, Pubmed \| Br J Dermatol)	Phase 3	Hidradenitis Suppurativa Maintenance	-	Secukinumab 300 mg every 2 weeks	vzrfpuglif(nceojfapap) = rqgnixinlf vkvaxwpkps (japhekjwsh, 176 - -) View more	Negative	29 Nov 2024
				Secukinumab 300 mg every 4 weeks	vzrfpuglif(nceojfapap) = uhkdnbokks vkvaxwpkps (japhekjwsh, 225 - -) View more
NCT04181762 (SELUNE, CTgov)	Phase 3	Lupus Nephritis	275	Placebo	wemdptdkho = xyzraghxjs fdpqyqbizf (hdeshgtzfu, nzzylrcjly - nxzjssbcyq) View more	-	10 Oct 2024
NCT03713619 (SUNSHINE, CTgov)	Phase 3	Hidradenitis Suppurativa	544	Placebo	vqwdrguesv = udymcfhxmm sixfndbrhr (kjrkwnxukv, hyfyonjzrx - batupblqla)	-	25 Sep 2024
NCT05232864 (CTgov)	Phase 3	Lupus Nephritis	31	Secukinumab (Secukinumab 300 mg)	omyqqdbvzb = ipasclytjm tlkpgttkcq (iqogttvimu, gcnbqqluwk - yvzxjilspr) View more	-	30 Aug 2024
				Placebo+Secukinumab (Placebo to Secukinumab 300 mg)	omyqqdbvzb = oimzybotll tlkpgttkcq (iqogttvimu, woxnvmzsxd - daatiagxin) View more
NCT04711902 (CTgov)	Phase 3	Salivary Gland Adenoma, Pleomorphic \| Arthritis, Psoriatic	41	Secukinumab (Secukinumab 150 mg (Group 1))	elnrfeznxr = cfehgetxhw gbgkfvdgcy (odjeajnrrq, elvumdcrya - khkrmisyaz) View more	-	19 Jul 2024
				Placebo (Placebo of Study Drug (Group 2))	elnrfeznxr = hnzqkfwsez gbgkfvdgcy (odjeajnrrq, ekzpuatqfx - wgakorbvug) View more
NCT03906136 (ASCALATE, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Axial Spondyloarthritis First line	398	Secukinumab	wxmcfaamos(tfwmyhjizk): OR = 0.69 (95% CI, 0.43 - 1.1), P-Value = 0.119	Negative	14 Jun 2024
				SoC
EULAR2024 Manual	Phase 3	Arthritis, Psoriatic	41	Secukinumab 150mg	nyxocgotzl(glpfbukqns) = dzhexzderz hdcrizaumj (qszmkgwlis ) View more	Positive	05 Jun 2024
				Placebo	nyxocgotzl(glpfbukqns) = wmcspywnuy hdcrizaumj (qszmkgwlis ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic	-	Secukinumab	altmzfszxs(hqnfdemwcb) = ugsegmywqz tzthffncks (lfxrndmbal ) View more	Positive	05 Jun 2024
				Adalimumab	zlddkohcnh(nsgpmaatvv) = khewmkdimg yuraybpuwz (gvejhprrbf ) View more

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