Latest news with #Scemblix
CNBC
17-07-2025
- Business
- CNBC
Swiss pharma giant Novartis bets on a breast cancer blockbuster as sales rise
Swiss pharmaceutical firm Novartis said Thursday that it expects its Kisqali breast cancer treatment to be the next blockbuster drug within its portfolio, as it looks to shift reliance away from its Entresto heart failure therapy. Sales of Kisqali, which treats metastatic breast cancer, surged 64% globally on a constant currency basis in the three months to June, the company said in its second-quarter sales report. That includes 100% growth in the U.S. It follows a 56% increase in Kisqali sales in the first quarter to March. Speaking on an earnings call, CEO Vas Narasimhan said Kisqali was the drug with the greatest scope for outperformance. Global breast cancer diagnoses and deaths are projected to increase by 2050, according to the World Health Organization's cancer agency, with 1 in 20 women worldwide expected to be diagnosed with breast cancer in their lifetime. That could translate to 3.2 million new cases and 1.1 million deaths a year worldwide by 2050 if current trends continue, the study found — significantly higher than 2022's 2.3 million new cases and 670,000-related deaths. Narasimhan also cited Novartis' "strong pipeline" of other drugs, including its Pluvicto prostate cancer treatment and Scemblix for chronic myeloid leukemia, which he said was also "on track to be a blockbuster." "We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio," he added in a statement accompanying the results. The comments come as Novartis seeks to shake its reliance on its top-selling Entreso heart failure drug, which faces U.S. patent expiry next year. Entresto brought in $7.8 billion in 2024, accounting for around 15% of the company's overall global sales. It said Thursday that it expects generic drug makers to begin producing copycat versions of the drug by mid-2025, although that timeline is "subject to ongoing IP [intellectual property] and regulatory litigation." On Wednesday, a U.S. federal judge rejected Novartis' request for a preliminary injunction to stop MSN Pharmaceuticals from selling a generic version of the drug before the patent expires. Sales of Entresto rose 22% in the second quarter, in line with the prior three-month period. "Short-term it's an important product for us," outgoing chief financial officer Harry Kirsch said of Entresto Thursday. "We have IP that we're defending. Should we be successful in further defending our appeal, each month we'll have some nice significant upside," he added. Overall, Novartis' second-quarter net sales rose 11% on a constant currency basis to $14.05 billion, just shy of the $14.18 billion estimated by analysts in an LSEG poll. Quarterly adjusted core operating income, meanwhile, rose 21% to $5.93 billion, slightly above the $5.69 billion expected. Novartis said it now expects full-year core operating income to grow by "low teens," up from "low double-digit" previously, while it retained its forecast for sales growth in the high single digits. The company also announced an up to $10 billion share buyback, citing "confidence" in its mid- and long-term growth.
Yahoo
02-06-2025
- Business
- Yahoo
ASCO25: Novartis hopes Scemblix becomes new standard for CML-CP
Novartis is hoping that Scemblix (asciminib) will become the physician's first choice of therapy for chronic myeloid leukaemia in chronic phase (CML-CP) after it has shown to be more tolerable than the standard of care (SOC) in a Phase IIIb trial. Scemblix is a first-in-class STAMP inhibitor which received accelerated approval by the US Food and Drug Administration (FDA) in 2021 in previously treated CML in adult patients. On 29 October 2024, the FDA granted accelerated approval to the drug as a first-line therapy in CML-CP. Interim data presented at the American Society of Clinical Oncology (ASCO) 2025 meeting, held from 30 May to 3 June in Chicago, from the ongoing ASC4START (NCT05456191) study showed the drug met its primary endpoint of superior tolerability. In the study, 120 patients were randomised to receive either Scemblix 80mg daily or nilotinib 300mg twice daily, a SOC tyrosine kinase inhibitor (TKI), with the primary endpoint looking at treatment discontinuation due to adverse events (AEs) or treatment-related deaths. Patients were evaluated for an average of 9.7 months with this preliminary data cutoff happening after 50 trial-reported AEs. At this cutoff, 10.9% of patients on Scemblix had discontinued treatment compared with 17.3% of patients on nilotinib, achieving the primary endpoint with a cause-specific hazard ratio of 0.45. Novartis added that the study is ongoing with further analyses planned for tolerability and efficacy of Scemblix with a 65-event cut-off. It follows the ASC4FIRST study (NCT04971226) for efficacy in which Scemblix outperformed SOC TKI with a major molecular response (MMR) rate of 74.1% at week 96 compared with 52% for those on SOC TKIs after 96 weeks of treatment. The company hopes this additional tolerability data will support physician preference for Scemblix as a first-line therapy for patients with CML-CP. While the data may convince physicians, its ability to become SOC will depend on the agencies and payers said Dr. Andreas Hochhaus, principal investigator and director of the University Tumor Center (UTC) at the Jena University Hospital, Germany. Speaking to Clinical Trials Arena, Hochhaus said: 'We did this study to convince the agencies in different countries for reimbursement because SOC means you need reimbursement, and it's important to show all kinds of data and that means efficacy, but also tolerability. In CML, we have improved survival almost to the survival expectation of the normal population. Therefore, this cannot be improved anymore, so you need other endpoints such as quality of life and AEs..' "ASCO25: Novartis hopes Scemblix becomes new standard for CML-CP" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-05-2025
- Business
- Yahoo
Enliven price target lowered to $27 from $36 at JonesResearch
JonesResearch analyst Soumit Roy lowered the firm's price target on Enliven (ELVN) to $27 from $36 and keeps a Buy rating on the shares. The company's abstract from the Phase 1 late line chronic myeloid leukemia trial with ELVN-001 'was met with a lukewarm initial stock reaction that weakened over time,' the analyst tells investors in a research note. The firm says that even though ELVN-001 showed efficacy and safety profile inline with the September 2024 update with two-times the patient population, the market treated the stock with a sell on news approach. Jones sees ELVN-001 performing at least inline with Novartis' Scemblix. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ELVN: Disclaimer & DisclosureReport an Issue Enliven Therapeutics' ELVN-001: Promising Competitor in the $3 Billion Late Line CML Market Enliven Therapeutics Reports Q1 Results and Pipeline Progress Enliven price target raised to $40 from $39 at H.C. Wainwright Enliven Therapeutics: Strategic Focus and Promising Developments Justify Buy Rating Positive Buy Rating for Enliven Therapeutics Driven by Promising Phase 1 Results of ELVN-001 in CML Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
