Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.

Start Date31 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06930859

/ Not yet recruitingNot Applicable

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.

Start Date31 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06849947

/ Not yet recruitingPhase 2IIT

Randomized Phase II Trial of Fulvestrant With Ribociclib Versus Physician's Choice Treatments for the Patients Who Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as First Line Treatment (CLEE011AKR06R)

▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment

Start Date30 Jun 2025

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Ribociclib Succinate

100 Translational Medicine associated with Ribociclib Succinate

100 Patents (Medical) associated with Ribociclib Succinate

1,351

Literatures (Medical) associated with Ribociclib Succinate

01 Jun 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of dual CDK4/6 and BRD4 inhibitor as apoptosis and autophagy inducers against NSCLC in vitro and in vivo

Article

Author: Luo, Zhongwen ; Zheng, Long ; Ma, Liangliang ; Zou, Meiting ; Zhang, Yonglei ; Kong, Lingyi ; Zheng, Yiwei ; Jiang, Yuhan ; Wang, Xiaobing

Target of cyclin dependent kinase (CDK) by inhibitors has demonstrated promising potential as a therapeutic agent for cancer. However, the efficacy of monotherapy on tumors is limited and there is an urgent need for combination therapy with other inhibitors. It has been reported that restoring bromodomain-containing protein 4 (BRD4) resensitivity to tumor cells by inhibiting CDK4/6 is a potential therapeutic strategy. In this study, we present the design and optimization of dual CDK4/6 and BRD4 inhibitors, among which B15 exhibited potent and selective inhibition of both targets in vitro, and significant antiproliferative effects in non-small cell lung cancer (NSCLC) cells. Importantly, it also showed good pharmacokinetic properties in rats, meanwhile, B15 effectively inhibited tumor growth in vivo (TGI = 85.3 %) without causing significant toxicity. Overall, our results introduce a promising strategy of dual CDK4/6 and BRD4 inhibitors for the treatment of NSCLC.

01 May 2025·INTERNATIONAL JOURNAL OF CANCER

Head‐to‐head comparison of palbociclib and ribociclib in first‐line treatment of HR‐positive/HER2‐negative metastatic breast cancer with real‐world data from the OPAL registry

Article

Author: Decker, Thomas ; Harbeck, Nadia ; Fricker, Roland ; Nusch, Arnd ; Zahn, Mark‐Oliver ; Wöckel, Achim ; Hagen, Volker ; Welt, Anja ; Thill, Marc ; Stickeler, Elmar ; Kaltenecker, Gabriele ; Dille, Stephanie ; Engelken, Kathrin ; Ringwald, Kai ; Kruggel, Lisa ; Zaiss, Matthias ; Gratzke, Katja ; Schulz, Holger ; Jänicke, Martina

Abstract:

Cyclin‐dependent kinase 4/6 inhibitors (CDKIs) in combination with endocrine therapy (ET) are the standard‐of‐care in the first‐line treatment of HR‐positive, HER2‐negative metastatic breast cancer. In the absence of direct head‐to‐head trials comparing the efficacy and safety of the different CDKIs, the individual choice of treatment in everyday practice is complex. Inverse probability of treatment weighting was used to emulate a head‐to‐head comparison of palbociclib +ET (PALBO) and ribociclib +ET (RIBO) in patients recruited into the prospective, observational, multicenter registry platform OPAL (NCT03417115). Progression‐free survival (PFS), overall survival (OS) and quality of life surveys were analyzed, also for subgroups stratified by treatment‐free interval (TFI). A total of 623 patients with HR‐positive, HER2‐negative metastatic breast cancer received PALBO (n = 388) or RIBO (n = 235) in their first line of treatment. No difference between PALBO and RIBO was found for PFS (median 26.7 months [23.6, 30.7] vs. 27.0 months [21.1, 30.4], HR 1.01 [0.80, 1.27]) and OS (median 42.4 months [38.8, 50.3] vs. 49.3 months [36.9, NA], HR 0.96 [0.71, 1.28]). There was a trend for longer PFS and OS in patients with TFI <12 months receiving RIBO. Patients reported comparable side effects for both CDKIs. This head‐to‐head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

01 May 2025·CLINICAL CANCER RESEARCH

Health-Related Quality of Life in Patients with HR+/HER2− Early Breast Cancer Treated with Ribociclib Plus a Nonsteroidal Aromatase Inhibitor: Results from the NATALEE Trial

Article

Author: Martín, Miguel ; Hortobagyi, Gabriel ; Chan, Arlene ; Huang, Chiun-Sheng ; Chia, Stephen ; Danyliv, Andriy ; Stroyakovskiy, Daniil ; Afenjar, Karen ; Loi, Sherene ; Slamon, Dennis ; Nowecki, Zbigniew ; Kukielka-Budny, Bozena ; Fresco, Rodrigo ; Untch, Michael ; Hurvitz, Sara ; Fasching, Peter A. ; Ferrusi, Ilia ; Yardley, Denise A. ; Rugo, Hope S. ; Li, Zheng

Abstract:

Purpose::

The phase III NATALEE trial reported a statistically significant invasive disease-free survival benefit with ribociclib plus nonsteroidal aromatase inhibitor (NSAI) versus an NSAI alone in stage II/III hormone receptor–positive, HER2-negative (HR+/HER2−) early breast cancer. In this study, we report health-related quality of life (HRQOL) data from NATALEE.

Patients and Methods::

Patients were randomized to receive ribociclib plus NSAI or NSAI alone. Patient-reported outcome scores [European Organisation for Research and Treatment of Cancer core quality of life questionnaire global health status and physical, social, and emotional functioning domains; the supplementary European Organisation for Research and Treatment of Cancer breast cancer–specific QOL questionnaire breast symptoms scale; health on a visual analog scale of the generic EuroQOL 5-level instrument; and the Hospital Anxiety and Depression Scale] were assessed. The prespecified primary HRQOL endpoint was physical functioning. Mean scores and time-categorical and prespecified linear-time repeated-measure models were used to evaluate HRQOL changes during treatment.

Results::

HRQOL was evaluated in all patients in the ribociclib plus NSAI (n = 2,549) and NSAI alone (n = 2,552) arms. Compliance was high in both arms (≈93%–97%). Mean scores did not differ meaningfully from baseline for any analyzed domain. Likewise, neither a meaningful change from baseline (in either treatment arm) nor a difference between arms was observed during treatment in the time-categorical, model-adjusted mean scores for any HRQOL domains—using published thresholds for interpreting longitudinal and between-group differences, with all values being within 0.5 SD of their baseline values. Linear-time regression analysis confirmed these findings.

Conclusions::

These analyses of NATALEE show that adding adjuvant ribociclib to an NSAI does not negatively affect HRQOL in patients with HR+/HER2− early breast cancer.

342

News (Medical) associated with Ribociclib Succinate

29 Apr 2025

·www.fiercepharma.com

As Novartis builds momentum with new drug launches, CEO says he's 'comfortable' navigating US tariffs

Novartis has raised its full-year guidance even after taking into account potential effects from upcoming U.S. tariffs on pharmaceuticals. Novartis has a lot cooking with new drug launches, and the company is not letting potential U.S. tariffs on pharmaceuticals get in the way of its progress.With recent indication additions, breast cancer drug Kisqali, radioligand therapy Pluvicto and third-generation tyrosine kinase inhibitor Scemblix all delivered double-digit year-over-year sales growth in the first quarter of 2025. Meanwhile, kidney disease drugs Fabhalta and Vanrafia are in the early days of their commercialization.The rollout of Kisqali in early-stage breast cancer has been top on investors’ minds given the $4 billion peak sales potential Novartis has pegged to the indication.In the first quarter, Novartis collected $956 million in global Kisqali sales, a 52% increase compared with the same period last year. The figure beat Wall Street’s estimates by 5%, according to analysts with ODDO BHF.With an FDA approval in the postoperative adjuvant setting in September, Kisqali has grown its new-to-brand share to 60%, Novartis CEO Vas Narasimhan told investors on a call Tuesday. And 56% of those newly added prescriptions are coming from the patient population that’s unique to Kisqali’s label, as opposed to those shared with Eli Lilly’s rival CDK4/6 inhibitor Verzenio, he said.In addition, considering Kisqali's tied-for-the-lead market share in the metastatic setting, the drug is on track to meet its $8 billion total peak sales goal set by Novartis, Narasimhan said. By comparison, Pluvicto appears to need some extra work. For the second quarter in a row, Pluvicto’s sales have missed analysts’ expectations. While the prostate cancer drug saw sales grow 20% year-over-year to $371 million, the number landed 7% below consensus estimates.Pluvicto won a key FDA nod at the end of March to treat PSMA-positive metastatic castration-resistant prostate cancer before taxane-based chemotherapy. This expansion has yet to be reflected in Pluvicto’s quarterly sales, though, as it takes about four to seven weeks for new patients to get treated after necessary scans and lab tests, Narasimhan explained.Initial uptake of Pluvicto for pre-taxane treatment will come from existing treatment centers that have been prescribing the radiopharmaceutical in the post-taxane setting. Novartis expects these accounts will drive Pluvicto’s growth in the second half of the yearBut to realize Pluvicto’s full potential, Novartis needs to expand its reach in the community and urology settings over time, as well as treat more patients at each center, Narasimhan said.Of the 620 treatment sites that Novartis has enlisted, only about half are running at a target number of patients, Narasimhan noted.Pluvicto is already gaining traction in the community setting for the post-taxane indication, with 4,000 total scripts as of the first quarter, which marked an 11% increase versus the prior-year level, according to Narasimhan. But it’ll take a combination of efforts to meet Novartis’ targets, he acknowledged, including making doctors more comfortable with the medicine, building capacity for imaging and easing the referral process.“We’re also continuing to increase—and have increased—our promotional spend,” the chief executive said. “We’ve doubled our field force, and are maintaining a very robust direct-to-consumer advertising campaign.”Thanks to strong growth from eight priority brands, Novartis beat analysts’ expectations with $13.2 billion sales in the first quarter, good for 12% growth year over year.The Swiss pharma raised its full-year 2025 guidance and now expects sales to grow at a high-single-digit percentage compared with 2024. Projecting confidence amid tariff uncertaintyNovartis is “fully comfortable” with this year’s projection, as well as its near-term guidance, because the company has baked in potential effects from the expected U.S. tariffs on pharmaceuticals, Narasimhan said during a separate press call with reporters.“In general, we believe we can manage through the tariffs for this year, and then we’ll have to, step by step, manage for subsequent years,” Narasimhan said.“Our goal, as I mentioned, is [to] have 100% of our products produced in the U.S. for the U.S.,” he continued. “We do have a little bit of a lower mix at the moment, but that, again, is something we believe is manageable.” To achieve that made-in-U.S. target, Novartis earlier this month unveiled a $23 billion plan to build and expand 10 U.S. facilities over the next five years. This includes the build-out of four new manufacturing facilities and two more new radioligand therapy production sites.During Tuesday’s investor call, Narasimhan acknowledged that the company could have made the investment plan sooner.“This is a strategic decision to say that the U.S. is our most important single market from a growth and revenue standpoint, and we want to be in a position to be able to produce all of our key medicines end-to-end in the U.S.,” he said.“I think independent of who’s president, it’s prudent for us to be able to have our supply chain stable inside the United States,” he added.

Drug ApprovalClinical Result

29 Apr 2025

·endpts.com

Novartis continues earnings winning streak as it raises 2025 sales expectations

Novartis is starting the year on a strong note as several of its core medicines beat Wall Street’s sales projections, prompting the drugmaker to shift its full-year guidance to a higher bar. In the first three months of 2025, the company’s net sales increased by 15% to $13.2 billion, beating Wall Street’s consensus of around $13 billion, the Swiss pharma said in a Tuesday release . With that, Novartis now expects net sales in 2025 to grow by high-single digits, up from a previous range spanning the mid- to high-single digits. This means Novartis could reach up to $55 billion in sales this year, Jefferies analysts said in a same-day note. Novartis’ Tuesday update follows its positive full-year 2024 earnings, which it described as one of the strongest in its history after its yearslong rejig as a pure-play pharma company. It achieved $50.3 billion in sales last year. As for its clinical pipeline, the company axed two programs: a chondrogenic asset called LRX712 and a radiopharmaceutical candidate dubbed GIZ943. Novartis dropped LRX712 after it showed “insufficient effect on knee cartilage” in a Phase 2 trial of patients with osteoarthritis, a company spokesperson told Endpoints News in an email. It nixed GIZ943, which was in development for ovarian and lung cancer, based on a Phase 1 risk-benefit assessment, the spokesperson said. The first half of 2025 should be especially strong, CFO Harry Kirsch said in a media call. Novartis expects generic competition for its heart failure drug Entresto, cancer medicine Tasigna and blood disorder treatment Promacta from midyear onwards. Products that performed better than the Street expected in Q1 included asthma drug Xolair ($456 million), spinal muscular atrophy therapy Zolgensma ($327 million) and Still’s disease treatment Ilaris ($419 million), according to Jefferies analysts. Meanwhile, Kisqali sales in the quarter grew 56% to $956 million, reflecting its position as “the CDK4/6 inhibitor of choice across metastatic and early breast cancer,” CEO Vas Narasimhan said on the call. And sales of cholesterol-lowering medicine Leqvio increased 72% to $257 million as it remains on track to reach blockbuster status this year. The company also highlighted that it won three FDA approvals in Q1, which should bolster its performance this year. In March, its radioligand drug Pluvicto was greenlit for certain prostate cancer patients who haven’t received chemotherapy. Pluvicto reached blockbuster status for the first time last year. Also in March, Fabhalta secured its third indication for an ultra-rare kidney disease called C3 glomerulopathy. And earlier this month, Vanrafia was approved for a rare kidney disease called IgA nephropathy.

Drug ApprovalPhase 1Clinical ResultPhase 2

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

100 Deals associated with Ribociclib Succinate

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KEGG	Wiki	ATC	Drug Bank
-	Ribociclib Succinate	L01XE	DB11730

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Metastatic breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Hormone receptor positive HER2 negative breast cancer	United States	Novartis Pharmaceuticals Corp.	13 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced HER2-Positive Breast Carcinoma	Phase 3	United States	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Portugal	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Spain	Novartis AG	28 Mar 2022
Early Stage Breast Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	07 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04539496 (BRIGHT-1, Pubmed \| Cancer Commun (Lond)) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	131	Bireociclib 480 mg BID	fhutnvwicn(zlmfilrqaa) = ievpkuamux vctmfjqqqe (lryuoouiyq, 22.1 - 38.4) View more	Positive	27 Feb 2025
NCT03237390 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm Rb status \| CDK2 \| CDK4/6 complexes	43	Ribociclib 800 mg daily + Gemcitabine 1000 mg/m2	mcjnvuvrbd(mejqwfmsvj) = ytuweyjzpk pdpujjfwsj (cndoriczem )	Positive	14 Jan 2025
NCT04256941 (CTgov)	Phase 2	Metastatic breast cancer	4	Fulvestrant (Fulvestrant)	qvkbvwezjr(xijhdwtflf) = eexanzxnep owvdxqiutr (iyyqsgdvbz, fdlkrwfiue - nyiawipiod) View more	-	27 Dec 2024
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	qvkbvwezjr(xijhdwtflf) = dwyahugftk owvdxqiutr (iyyqsgdvbz, ynxainbcuk - bsezbrgwxz) View more
NCT05508906 (Company_Website) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer First line	63	Palazestrant + Ribociclib	tzinixsjkm(xeluortfwo) = gizivuvjfq xepqjkxcpy (dgnytkaaqn ) View more	Positive	10 Dec 2024
				Palazestrant + Ribociclib (prior treatment with a CDK4/6i plus an endocrine therapy)	tzinixsjkm(xeluortfwo) = usnfhditzf xepqjkxcpy (dgnytkaaqn ) View more
ESMO_ASIA2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	380	Ribociclib	pkngzodwwq(lrvytnlbwb) = otdlvimoab dwnskcliek (pfaoqecepy ) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HER2 Negative \| Hormone Receptor Positive	377	Palbociclib	xykvyvcael(bahhpkuxqq) = zfaodhurka ugjnbzrfzc (ewzaetzjpy ) View more	Similar	07 Dec 2024
				Ribociclib	xykvyvcael(bahhpkuxqq) = yceasayjil ugjnbzrfzc (ewzaetzjpy ) View more
NCT02278120 (MONALEESA-7, ESMO_ASIA2024)	Phase 3	Hormone receptor positive breast cancer	672	Ribociclib+Endocrine Therapy	dxkiwcexfl(dgxrwbxsto) = zriunnwwow tufswkpahq (rvauybnxav )	Positive	07 Dec 2024
				Placebo+Endocrine Therapy	dxkiwcexfl(dgxrwbxsto) = avhhzmwlga tufswkpahq (rvauybnxav )
NCT02632045 (MAINTAIN, CTgov)	Phase 2	Advanced breast cancer	169	Placebo+Fulvestrant (Placebo/Fulvestrant)	xbyfrsbkeg(whmhmczhlv) = tygvpvauzr vusjofxnbt (cvnnmekslk, tdljufnngt - mrfbunjfrb) View more	-	06 Dec 2024
				Fulvestrant+LEE-011 (Ribociclib (LEE-011)/Fulvestrant)	xbyfrsbkeg(whmhmczhlv) = xkxetnnvff vusjofxnbt (cvnnmekslk, nwfsvvocge - qgjhmwfsku) View more
NCT04657679 (LEANORA, CTgov)	Phase 4	Breast Cancer	21	Ribociclib (African American/Black)	wspyikoqpk(owyxnizjmg) = yjndbgwzzd wlztjhwniz (hsvyzwllxs, nxvsclaoqg - hipqgalzkq) View more	-	26 Nov 2024
				Ribociclib (Non-Hispanic White)	dyjfttfsnn(fqruvitdga) = aknnlwzzjb cuynebhujh (udwmycxftw, lzromigcge - itoqypznee) View more
CCRG-04 (SNO2024)	Not Applicable	Breast Cancer estrogen receptor \| progesterone receptor \| HER2 negative	1	Ribociclib	wjjwyxmymj(wauwtubfez) = sqcmkefvty ljobpvclmk (gwnlzqycwc )	Positive	11 Nov 2024

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