Wizz Air Cuts Back Ambitious Airbus Deliveries to Control Costs
The Hungarian airline is looking to slow deliveries from Airbus SE, cut back its A321 XLR order book and downsize its Middle East operations, Chief Executive Officer Jozsef Varadi said on Thursday in an interview. The carrier didn't provide guidance for fiscal 2026 in its earnings report, and the stock dropped as much as 10% in early trading.
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AXA wins UK court ruling against Santander over PPI claims
Frensh insurer AXA has won a legal case in a London court, resulting in a ruling of approximately £680m (€781.53m) against Santander for the mis-selling of payment protection insurance (PPI). The issue involved losses from mis-selling complaints related to PPI policies underwritten by two companies acquired by AXA from Genworth in 2015. These policies were originally sold by a company that Santander acquired in 2009. The legal proceedings initiated by AXA in the High Court of London in 2021 were prompted by losses associated with more than 650,000 customer complaints regarding PPI policies, with banks having disbursed around £40bn in compensation, according to Reuters. AXA, which assumed responsibility for these liabilities following its acquisition of two Genworth units in 2015, has already paid nearly £500m in consumer redress and over £70m related to complaints, Judge Julia Dias said in her ruling. In her judgement, Judge Dias confirmed that AXA "has a valid claim for an indemnity" against Santander Insurance Services UK concerning the payments made for redress and fees associated with the ombudsman. Legal representatives for AXA at Quinn Emanuel indicated that the ruling's value is estimated at £675m. However, an AXA spokesperson clarified that the company would only receive a portion of the total amount awarded, as Genworth has already compensated AXA for a significant share of the losses incurred from the mis-selling. Genworth Financial stated that it anticipates receiving around $750m, contingent on the current exchange rate. In response to the ruling, a spokesperson for Santander expressed disagreement with the court's decision and indicated plans to appeal. The spokesperson further stated: "We do not expect the net impact of the judgment to be material for Santander given provisions already made and the potential legal actions available. 'No customers have suffered loss as a consequence of the claim brought by AXA France or the judgment, nor does it impact upon past redress paid to customers for PPI complaints." "AXA wins UK court ruling against Santander over PPI claims" was originally created and published by Life Insurance International, 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. Sign in to access your portfolio
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Novo Nordisk faces 'show me' moment to boost Wegovy growth after US copycat ban
By Maggie Fick LONDON (Reuters) -A U.S. ban on copycat versions of Novo Nordisk's Wegovy has begun to lift use of the weight loss drug, but the company will need to show more robust growth in the months ahead to bolster market confidence, investors and analysts say. New Wegovy prescriptions have increased by about 33% since May 22, when a U.S. Food and Drug Administration ban on so-called compounded versions of Wegovy took effect, amounting to 181,200 in the week ended July 18, according to data from IQVIA that was shared with Reuters by industry analysts. Total Wegovy prescriptions have also increased, narrowing the lead for Eli Lilly and Co's Zepbound. In the week ended May 23, U.S. Zepbound prescriptions exceeded Wegovy by nearly 175,000. By July 18, the gap was about 133,000. Early signs of a shift come at a critical juncture for Novo. After Wegovy's initial stunning success, investor confidence was rattled when Zepbound and compounders started to slow the drug's growth. And then in May, the Danish company cut its full-year sales and earnings forecasts and announced the surprise exit of Chief Executive Lars Fruergaard Jorgensen, citing market challenges and a stock price nearly 60% below its 2024 peak. Jorgensen said at the time he expected the FDA compounding ban to lift sales in the second half of this year. Investors are keen to hear whether that is still likely when the company reports quarterly earnings on August 6. That leaves the drugmaker in what Barclays analyst Emily Field called a "show me" phase - no longer buoyed by optimism about a turnaround but under pressure to deliver. She has an "overweight" rating on Novo's shares. "We thought this trajectory change (in new prescriptions) would get the shares moving, but not so far," Berenberg analyst Kerry Holford told Reuters. "I suspect investors are now waiting for the (second quarter) update - will they/won't they trim guidance range? I think they will trim the top." Berenberg has a "hold" rating on Novo. Novo did not respond to a request for comment. Investors and analysts note that the IQVIA prescription data is incomplete, because it does not capture sales of Wegovy through the company's direct-to-consumer platform, NovoCare, launched in March. They estimate the channel is still a small slice of overall Wegovy volume. "We would hope to see strong growth from the NovoCare channel but are cognizant that this may come at initially lower prices" due to discount offers, said Marcus Morris-Eyton, a portfolio manager at Alliance Bernstein, whose fund holds Novo shares. "Sentiment towards Novo Nordisk is currently exceptionally weak, but given low expectations, the low valuation and hopefully accelerating prescription data in (the second half of 2025) we believe the market is underestimating Novo's long term growth potential," he said. BRINGING BACK PATIENTS Booming sales of Wegovy catapulted Novo to become Europe's most valuable listed company, peaking in June 2024 at about 615 billion euros, after the weekly injection became the first highly-effective obesity treatment approved in the U.S. in 2021. But supply disruptions and gaps in health insurance coverage for Wegovy helped fuel the market for cheaper compounded - or copycat - versions, which are allowed under U.S. law when drugs are in shortage. Investor sentiment on Novo soured after the company lost ground to U.S. rival Eli Lilly, which launched Zepbound in late 2023. In its first full-year forecast downgrade since Wegovy's launch, Novo said in May it expected local-currency sales growth of 13–21%, down from a previous forecast of 16–24%. Operating profit growth is projected at 16–24%, versus 19–27% previously. Capturing more of the patients who had turned to compounded drugs is key to meeting those targets. The FDA determined that Wegovy was no longer in shortage in February, leading to the ban on compounded versions. Novo has rolled out new tactics to bring patients back, including a limited-time discount for one month's supply, and secured better coverage from insurer CVS Health. Analysts at Berenberg and UBS are sceptical these moves will provide enough momentum and expect that Novo will reduce or narrow its full-year guidance ranges, according to research notes. TD Cowen said the outcome was hard to predict due to limited visibility on NovoCare. Bank of America and Guggenheim said they did not expect another guidance cut and Barclays said it was unlikely. ($1 = 0.8513 euros)
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BeOne Medicines Receives Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment
Recommendation based on Phase 3 RATIONALE-315 study, in which TEVIMBRA demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological response If approved, the expanded label builds on TEVIMBRA's momentum in lung cancer with EU approvals already in NSCLC and SCLC indications across both first- and second-line settings SAN CARLOS, Calif., July 28, 2025--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA® (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. This recommendation is based on the Phase 3 RATIONALE-315 study (NCT04379635). "Patients with resectable, early-stage NSCLC face an urgent challenge – despite surgery and current therapies, recurrence rates remain alarmingly high," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at the Faculty of Medicine of Universidad Autonoma de Madrid in Spain. "The significant clinical benefit observed in the RATIONALE-315 study has important implications for patients. If approved, perioperative tislelizumab will offer oncologists a powerful new option to improve outcomes and potentially alter the course of this difficult-to-treat disease." RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 20241, the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include: Statistically significant and clinically meaningful improvement in MPR and pathological complete response (pCR) rates: 56.2% of NSCLC patients treated with TEVIMBRA in combination with chemotherapy before surgery achieved MPR compared to 15.0% of patients treated with chemotherapy in combination with placebo (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001) 40.7% of patients on the TEVIMBRA-based regimen achieved pCR, compared to 5.7% of patients treated with chemotherapy in combination with placebo (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001) Statistically significant EFS (HR [95% CI], 0.56 [0.40–0.79]; 1-sided P=0.0003) and trend for overall survival (OS) (HR [95% CI], 0.62 [0.39–0.98]; 1-sided P=0.0193) benefits favoring TEVIMBRA in early data. Consistent safety profile of the TEVIMBRA arm with that of individual therapies, with 72.1% of patients in the TEVIMBRA arm (vs. 66.4% in the placebo arm) experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% of patients in the TEVIMBRA arm (vs. 8.0% in the placebo arm) experiencing serious TRAEs. There were no new safety signals identified with this regimen, and the most common Grade 3 or 4 TRAEs (≥ 10%) in the TEVIMBRA arm were decreased neutrophil count and decreased white blood cell count. No impact on the feasibility and completeness of surgery, a key concern around neoadjuvant treatment. Updated EFS and OS data from the pre-planned final analysis of RATIONALE-315 will be submitted for presentation at an upcoming medical conference. "TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients." In lung cancer, TEVIMBRA is already approved in the EU for the first-line treatment of patients with squamous NSCLC, for the first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression, for the treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, and as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also approved as a first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, and as a first-line treatment for patients with nasopharyngeal carcinoma (NPC). About NSCLC Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.2 In Europe, lung cancer is the third most frequent cancer with 484,306 new cases diagnosed in 2022.3 NSCLC accounts for 80–90% of all lung cancers4, of which resectable NSCLC patients at diagnosis represent around 25–30%5. About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency. This information is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne's plans, commitments, aspirations, and goals under the heading "About BeOne." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled "Risk Factors" in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom site. ______________________________ 1 Yue, D., et al. (2024, March). VP1-2024: RATIONALE-315: Event-free survival (EFS) and overall survival (OS) of neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS in resectable non-small cell lung cancer (NSCLC). Annals of Oncology, 35 (3), 332-333. 2 Bray, F., et al. (2022). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 74(3):229-263. 3 Ferlay, J., et al. (2024). Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. 4 European Society of Medical Oncology. Non-small-cell lung cancer: A guide for patients. 5 Isla, D., Majem, M. (2022). A paradigm shift for resectable non-small cell lung cancer. Archivos de Bronconeumologia. 58(12):792-793. View source version on Contacts Investor Contact Liza Heapes+1 857-302-5663ir@ Media Contact Kyle Blankenship+1 610-256-8932media@
